Navitas Life Sciences is delighted to be exhibiting at Booth 49 at the upcoming Outsourcing in Clinical Trials East Coast 2023. The event will explore effective strategies for outsourcing clinical trial operations to ensure trials run smoothly and within budget.

We encourage you to come and meet our team of experts and discuss how we can support your clinical trial needs to help bring your drugs to the market sooner. If you would like to arrange to meet with our team please click here.

For further information, please visit the event website at: https://www.arena-international.com/event/octeastcoast/

We are delighted to confirm that Navitas Data Sciences are a Gold Sponsor at the upcoming PharmaSUG 2023 event. Our team of subject matter experts is looking forward to meeting with you at Booth 315/412.

The theme for this event is ‘Putting Digitalization to Work’ with many of our team presenting over the course of the event:

As the Functional Service Provider (FSP) of Data Services for Navitas Life Sciences, we have global solutions for all your Statistical Programming, Biostatistics, Data Management, and Project Management needs.

If you would like to arrange to meet with our team and learn how we can help you to meet the future challenges of Data Requirements in your clinical trials, then please click here.

For further information or to register your interest in attending this meeting, please visit the PharmaSUG website: https://www.pharmasug.org/us/index.html

We are pleased to share that Dr. Akash Gadgade, Senior Manager - Medical and Scientific Affairs, Navitas Life Sciences, will be sharing his knowledge, expertise, and experience with students of Pharmacology at the Jawaharlal Nehru Medical College as he delivers a session as part of their upcoming event which will address career prospects for MD Pharmacology and look at elective posting for MBBS CBME batch.

For further information about the Pharmacology Department at Jawaharlal Nehru Medical College please visit: https://jnmc.edu/m-b-b-s-phase-ii/department-of-pharmacology/

We are delighted that our PV and Medtech Networks Thought Lead, Dr. Latika Sharma, MBBS, MD, will be presenting as session at Sidley’s mtlegal Spring Biannual Meeting which is taking place in Belgium.

Join Latika between 14 :00 – 14 :45 as she explores ‘Navigating Combination Products for Patient Safety Organizations’ her session will address:

• Combination products – the rising meteor
• Combination products in pharma – complexity and challenges
• Safety obligations – device vigilance and pharmacovigilance
• Considerations for the future safety organizations

About mtlegal

Sidley’s mtlegal is the newest benchmarking group for in-house counsel in the medical devices and in vitro diagnostic industry. In the same way as Sidley’s other groups, in-house regulatory counsel have the opportunity to benchmark their company's compliance with MedTech regulations against peers in the industry.

We are pleased to share that Dr. Akash Gadgade our Senior Manager - Medical and Scientific Affairs will be presenting a workshop session for the National Association of Pharmacology and Therapeutics that will focus on SAE and compensation guidelines in India as per NDCT 2019.

For further information or to register, please visit the event website here: https://www.nationalpharmacology.org/Images/GCP2023.pdf

This March we are delighted to bring together our pvnet membership as part of a working group as they discuss Translational Safety in PV organizations – Why now? Where next?

Moderated by our PV and Medtech Networks Thought Lead, Dr. Latika Sharma we will look at just what translational safety means for patient safety organizations. We are delighted to welcome our industry expert speaker, Dr. Claire Brulle Wohlhueter, Head of Translational Safety at Sanofi, and industry expert panelist, Dr. Lin Zhang, VP and Head of Clinical Safety and PV at Daiichi Sankyo as they:

• Review emerging trends in translational safety
• Align on a common definition
• Agree on operating models
• Explore opportunities to futher shape the future of translational safety in PV

This session is open to pvnet members and senior experts from large biopharmaceutical companies. If you would like more information about this network, or details about how to join our upcoming meeting, please click here.

cmonet is a network for Chief Medical Officers, addressing strategic and governance topics within the remit of the CMO.

Please be advised that this is an invitation-only event.

For further information please contact us at cmonet@navitaslifesciences.com

Navitas Life Sciences are delighted to be attending the DIA Europe 2023 meeting in Basel.

If you would like to arrange to meet with our PV and MedTech Networks Thought Lead, Dr Latika Sharma, onsite then please click here to schedule a meeting.

For further information please visit the event website: https://www.diaglobal.org/en/flagship/dia-europe-2023

We are delighted to be a media sponsor for the upcoming PHUSE India Spring Single Day Event. Navitas Data Sciences’ Shrishaila Patil will be producing his fifth event in his role as India SDE Lead. Taking place on 18 March, the event will be focused on ‘Open-source technologies in Data Sciences and Analytics – Making it happen, making it matter.’

We look forward to the first face-to-face event of the year. For further information or to register your place, please click here.

pvindia is a network for PV leads of life sciences companies in the APAC region with Pharma, Consumer, Generics, or mixed portfolios. Launched in March 2016, pvindia provides a neutral platform for pharmacovigilance leaders facing similar challenges to network, debate, compare performance, and share ideas on how to tackle the latest hot issues.

We are delighted to be hosting our 14th forum this Spring.

For further information, or to register your interest, please contact us at pvindia@navitaslifesciences.com

medtechnet is a network for Safety, Regulatory, and Labeling leaders from pharma and medical technology companies to partner and shape NextGen Device and Combination Product Safety.

Following the successful inaugural launch of medtechnet in December 2021 we are delighted to host our 5th roundtable.

For further information or to register your interest in attending this meeting, please contact: networks@navitaslifesciences.com

The Navitas Data Sciences team is delighted to be a Platinum sponsor and exhibitor at the PHUSE US Connect 2023 event. Our team of subject matter experts is looking forward to meeting with you at exhibition booth #9.

Navitas Data Sciences is the Functional Service Provider (FSP) of Data Services for Navitas Life Science, we build bespoke global solutions to support your Statistical Programming, Biostatistics, and Data Management needs.

If you would like to schedule time to meet with a member of our team at the event and discuss how we may help you to meet the future challenges of Data Requirements in your clinical trials, please click here.

For further information or to register your interest in attending this meeting, please visit the PHUSE website: https://phuse.global/

We are delighted that Navitas Life Sciences’ Senior Managing Consultant, Carolyn Lyons, will be attending Sidley’s pvlegal Spring Biannual Meeting.

pvlegal is a membership-based forum for in-house counsel and compliance personnel working on drug and device safety issues in the life sciences sector. The network focuses on topics relating to the monitoring, surveillance, detection, assessment, and regulatory reporting of adverse events or reactions, and provides legal and regulatory updates to support pvlegal members in the U.S. and the EU. This is supported by regular benchmarking of member performance and best practice sharing in the area of drug and device safety surveillance and reporting. Sidley Austin LLP serves as counsel to pvlegal. Additional support and sponsorship is provided by Navitas Life Sciences.

For further information please click here or contact the pvlegal team directly via email at pvlegal@sidley.com

Navitas Life Sciences are delighted to be a Platinum Partner for the upcoming ISCR 16th Annual Conference taking place 24 – 25 February 2023 in New Delhi. The theme of this event is Demystifying Innovations in Clinical Trials with highlighted topics to include: current regulations, contemporary trends in clinical trials, processing and reporting of clinical trial data, and technology driven innovations in clinical research to name but a few.

Our team will be available at our booth within the exhibition area as well as participating in the following sessions:

24 February | 15:00 – 16:00 IST | Panel discussion - Innovation as a way of life in Pharmacovigilance

24 February | 16:30 – 18:00 IST | Presentation – How does CDM adapt to the DCT trials?

25 February | 15:00 – 16:30 IST | Presentation - Centralized Medical Data Review at the Core of RFBM: The Path to Success

If you would like to arrange to meet with our team onsite then please click here to schedule a meeting.

For further information please visit the event website: http://iscrconference2023.org/index.php

We are delighted that Navitas Life Sciences’ Senior Manager – Medical Services, Dr. Akash Gadgade, will be presenting a session titled ‘WHODrug SDGs and CDGs from an investigator’s point of view’ at the WHODrug User Group meeting in India, we hope that you can join us between 14:30 – 15:05 for what we are sure will be an insightful session.

For further information about WHODrug please visit: https://who-umc.org/whodrug/

Navitas Life Sciences are delighted to be attending the DIA Regulatory Submissions, Information, and Document Management Forum. The event will bring together industry and regulatory stakeholders working across the scope of regulatory information to examine current and evolving data standards and requirements and effective regulatory information management approaches to align related people, processes, and technology. The forum will present four tracks:

• Regulatory Information Business
• Regulatory Informatics Technology
• Trial Master File (TMD) Inspection Readiness and Electronic Document Management
• Electronic Regulatory Submissions

February 15, 2023 | 08:30 – 09:45

Session 9 | Track 3 | Using Automation to replace manual documentation processing, realize resource efficiencies, and gain valuable insights into your data

We look forward to hearing our partner, Glemser Technologies, present as part of this session. Join Jamie Morisco, Director of Client Success, as he explores Natural Language Processing for Life Sciences. To learn more about our partnership please click here.

If you would like to arrange to meet with our Vice President, Business Partner Regulatory and Safety Technology, Govind Srinivasan, at the event please click here.

For further information or to register to attend, please visit the event website: https://www.diaglobal.org/en/conference-listing/meetings/2023/02/regulatory-submissions-information-and-document-management-forum

Navitas Life Sciences are delighted to present a webinar on Technology Enabled Centralized Data Surveillance in Risk Based Monitoring: Thinking the Unthinkable

The webinar will explore the following key themes:

• Remote data collection, centralized monitoring, and decentralized clinical trials
• Centralized monitoring: a greater advantage to a broader range of trials
• What is Risk-Based Monitoring (RBM) and how the RBM approach can improve clinical trial data quality
• Successful RBM execution and harmonization

To register your place please click here.

We are delighted to be a media sponsor for the upcoming PHUSE India Winter Single Day Event. Navitas Data Sciences’ Shrishaila Patil will be producing his fourth event in his role as India SDE Lead for 2022. Taking place on 10 December, the event will be focused on the Application of Artificial Intelligence (AI), Machine Learning (ML), and Natural Language Processing (NLP) in Clinical Trials.

We look forward to the second face-to-face event of the year. For further information or to register your place, please click here.

We are delighted to confirm that our Senior Vice President, Statistical Programming, Shrishaila Patil K, will be presenting at the upcoming SCDM India Annual Conference 2022.

The session titled Introduction to Metadata and Standards in Clinical Trials is part of the ‘Solutions for effective metadata and standards management in clinical studies’ theme and will take place as follows:

Saturday 03 December | 11:30 – 13:00 IST

For further information, please visit the event website: https://scdmindia.org/index.php

labelconnect is a network for labeling leaders of large and mid-sized life sciences companies, with a specific focus on operational aspects of the full life cycle of labeling.

The themes for the labelconnect forum are Outsourcing and Offshoring Strategies and End-to-End Labeling Governance

For further information, or to register your interest, please contact us at labelconnect@navitaslifesciences.com

Established in 2001, pvnet is a network for Heads of Safety of top 30 life sciences companies, invests in thought leadership to help shape future practices.

The theme for the pvnet Autumn week two session is Rewriting the PV Playbook – Poetry and Prose.

For further information, or to register your interest, please contact us at pvnet@navitaslifesciences.com

pvtech is a network for Heads of Information Technology for PV departments, focused on increasing business value from technology investments.

The theme for the pvtech forum is Digital PV Choices – Bespoke or Be all?

For further information, or to register your interest, please contact us at pvtech@navitaslifesciences.com

labelnet is a network for labeling leaders of large and mid-sized life sciences companies, with a specific focus on strategic aspects of the full life cycle of labeling.

The theme for the labelnet Autumn week two session is E-Labeling and Digital Labeling.

For further information, or to register your interest, please contact us at labelnet@navitaslifesciences.com

Established in 2006, pvconnect is a network for Heads of Safety of mid-sized life science companies with a range of product portfolios including one or more of Pharma, Biologicals, Consumer, and Medical Devices.

The theme for the pvconnect Autumn week two session is New Tools for Global Harmony.

For further information, or to register your interest, please contact us at pvconnect@navitaslifesciences.com

Navitas Life Sciences are pleased to be an exhibitor sponsor at the Sparta Systems TrackWise User Group India 2022 meeting.

We have been working together with Sparta Systems for over 10 years, helping to simplify the technology landscape to enable better outcomes for our clients and to drive informed decisions. We look forward to participating at this event, joining industry peers as we explore the latest solutions, features, and benefits of TrackWise and TrackWise Digital.

labelnet is a network for labeling leaders of large and mid-sized life sciences companies, with a specific focus on strategic aspects of the full life cycle of labeling.

We are delighted to host a face-to-face event for labelnet members. The theme for the labelnet Autumn week one session is Future Fit Labeling Organizations.

For further information, or to register your interest, please contact us at labelnet@navitaslifesciences.com

Established in 2001, pvnet is a network for Heads of Safety of top 30 life sciences companies, invests in thought leadership to help shape future practices.

We are delighted to host a face-to-face event for pvnet members. The theme for the pvnet Autumn week one session is Rewriting the PV Playbook – Poetry and Prose.

For further information, or to register your interest, please contact us at pvnet@navitaslifesciences.com

rimnet is a network for Global Heads of Regulatory Affairs and RIM IT professionals to create transformational enterprise solutions for Regulatory Information Management

The theme for the rimnet Autumn session is RIM – Transitioning to Data Excellence and Automation

For further information, or to register your interest, please contact us at rimnet@navitaslifesciences.com

Established in 2006, pvconnect is a network for Heads of Safety of mid-sized life science companies with a range of product portfolios including one or more of Pharma, Biologicals, Consumer, and Medical Devices.

We are delighted to host a face-to-face event for pvconnect members. The theme for the pvconnect Autumn week one session is Reimagining PV – Where are we? Spotlight on Science, Digital, and Value.

For further information, or to register your interest, please contact us at pvconnect@navitaslifesciences.com

Navitas Life Sciences are excited to be back exhibiting with CPHI at the CPHI Frankfurt 2022 event taking place 01 – 03 November. Come and find us in the ICSE zone where our team of subject matter experts looks forward to meeting with you at booth 91H74.

If you would like to preschedule a time to meet with our team to discuss your key objectives and learn how we can help support your Generic Drug Development needs with our end-to-end services to help bring your product to market quickly and effectively please click here.

For further information about the event, please visit the CPHI website: https://www.cphi.com/europe/en/home.html

Navitas Data Sciences are pleased to be a Ruby Sponsor at the CDISC 2022 US Interchange. Our team of subject matter experts looks forward to meeting with you at exhibition Booth 19.

Navitas Data Sciences is the Functional Service Provider (FSP) of Data Services for Navitas Life Sciences and has global solutions for all your Biostatistics, Statistical Programming, and Data Management needs.

If you would like to arrange to meet with our team of experts and learn how we can help you to meet the future challenges of Data requirements in your clinical trials, please click here.

Navitas Life Sciences is delighted to be attending the IoPP Pharmaceutical and Medical Device Labeling Committee Leadership Meeting. The meeting’s theme is ‘Explore New Innovations’.

Our Managing Consultant, Debi Schimpf, will be presenting between 14:00 – 14:45 on 23 October.

For further information or to register your interest in attending this meeting, please visit the event website here.

Navitas Clinical Research is delighted to be attending the 8^th International Symposium on Focused Ultrasound which is taking place as a hybrid event.

Our Senior Clinical Project Manager - Clinical Operations, Sarah Lawrence, will be onsite and would be delighted to discuss your objectives and how we can help optimize your clinical trials for augmented market reach. To arrange to meet with Sarah please click here.

For further information or to register your interest in attending this meeting, please visit the event website: https://symposium.fusfoundation.org/

medtechnet is a new network for Safety, Regulatory, and Labeling leaders from pharma and medical technology companies to partner and shape NextGen Device and Combination Product Safety.

Following the successful inaugural launch of medtechnet in December 2021 we are delighted to host our 4^th roundtable. The agenda for this event will be released shortly.

For further information, or to register your interest, please contact us at networks@navitaslifesciences.com

cmonet is a network for Chief Medical Officers, addressing strategic and governance topics within the remit of the CMO.

The theme for this event is Governance of Digital Health Platforms.

Please be advised that this is an invitation-only event.

For further information please contact us at cmonet@navitaslifesciences.com

pvindia is a network for PV leads of life sciences companies in the APAC region with Pharma, Consumer, Generics, or mixed portfolios. Launched in March 2016, pvindia provides a neutral platform for pharmacovigilance leaders facing similar challenges to network, debate, compare performance, and share ideas on how to tackle the latest hot issues.

We are delighted to be hosting our 13th forum this Autumn. The themes for this event are Patient Engagement with Technology and Automation

For further information, or to register your interest, please contact us at pvindia@navitaslifesciences.com

Navitas Life Sciences are delighted to be hosting a live webinar titled ‘Innovation and Optimization in Early Phase Oncology Studies’ to be conducted on Thursday October 06, 2022.

The webinar will explore the opportunities available for speed, success, and savings, addressing:

• How applying innovative designs in early phase oncology trials can accelerate timelines and reduce costs
• How to focus development on the most promising agents at the right doses in the right indications for the right patients
• Simple strategies on Dose Escalation: A legacy of statistical innovation
• Expert insights on Novel endpoints to sail through dose expansion and proof of concept

To register your place for this webinar please click here.

Navitas Life Sciences are pleased to be exhibiting at the World Drug Safety Congress Americas taking place in Boston, MA.

If you would like to arrange to meet with our team of experts at the event, then please click here.

We would love to learn more about your objectives and discuss how we can help with our End-to-End Pharmacovigilance Services, combining Artificial Intelligence (AI) and smart processes to advance drug development and deliver solutions.

For further information or to register your interest in attending this meeting, please visit the event website: https://www.terrapinn.com/conference/world-drug-safety-us/index.stm

labeltech is a network for Regulatory and IT professionals; focused on exploring end-to-end labeling technologies to improve processes and increase business value.

The labeltech forum will explore End-to-End Labeling Technologies. A detailed agenda will be released shortly.

For further information, or to register your interest, please contact us at labeltech@navitaslifesciences.com

We are delighted to be a sponsor and exhibitor at the upcoming PHUSE Computational Science Symposium 2022. The event will provide a wealth of opportunities to learn, contribute, and collaborate with the following PHUSE Working Groups taking part:

• Data Transparency
• Data Visualization and Open Source Technology
• Emerging Trends and Technologies
• Nonclinical Topics
• Optimizing the use of Data Standards
• Safety Analytics

Please do visit our team at exhibition Booth 6. If you would like to pre-schedule a meeting with our team of data science experts, please click here.

For further information about the event, please visit the PHUSE website here.

labeltech is a network for Regulatory and IT professionals; focused on exploring end-to-end labeling technologies to improve processes and increase business value.

The labeltech forum will explore End-to-End Labeling Technologies. A detailed agenda will be released shortly.

For further information, or to register your interest, please contact us at labeltech@navitaslifesciences.com

We are delighted to be a media sponsor for the upcoming PHUSE India Autumn Single Day Event. Navitas Data Sciences’ Shrishaila Patil will be producing his third event in his role as India SDE Lead for 2022. Taking place on 17 September the day will be focused on Data Analysis and Reporting of New Age Clinical Trials, exploring automation in clinical programming, standards, latest protocol designs, RWD, RWE, and more. We are also pleased to confirm that our Associate Manager and Statistical Programmer, Ram Mohan Konda, will also be presenting a session titled Automation by Macro’s in SAS programming as he explores how automating unique tables and listings using macros can save Statistician time, reduce human error, and deliver high-quality work.

For further information about this virtual event or to register your attendance, please visit the event website by clicking here.

Navitas Life Sciences are pleased to be attending the RAPS Convergence 2022 event in Phoenix, Arizona.

If you would like to schedule a time to meet with Govind Srinivasan, Vice President and Business Partner for Regulatory and PV Technology, then please click here.

We would love to learn more about your organization’s objectives and discuss how we can help with our End-to-End Regulatory Services, offering fit-for-purpose, cost-effective solutions for small, mid-sized, and large pharma companies.

For further information or to register your interest in attending this meeting, please visit the event website: https://www.raps.org/convergence-2022/home

The Navitas Life Sciences team is excited to be exhibiting at the 24^th SCDM Annual Conference which will reconnect the global Clinical Data Management community, celebrate imaginative ideas and pioneering mindsets, as well as inspire delegates.

We look forward to welcoming you to booth 111 where we can discuss your objectives and how we can support you with data-driven, patient-centric, and efficient trials to help speed your product to market. If you would like to preschedule a time to meet with our team, please click here.

For further information about the event, please visit the SCDM website: https://scdm2022.org/

We are delighted that our Global Head Generics, Dr. Ayaaz Hussain Khan, will participate in this upcoming virtual roundtable as part of a panel discussion.

As we emerge from the global COVID-19 pandemic, this event will explore the challenges faced, the lessons learned, and the successes gained in the field of Clinical Trials. Key discussion points include:

• Lessons learned while conducting clinical trials during the pandemic
• Decentralized clinical trials
• Technology adoption and organization restructuring for new age clinical trials
• Use of Real-World Data
• Integration of Cloud

For further information or to register your seat, please visit the event website: https://health.economictimes.indiatimes.com/webinar/the-future-of-clinical-trials-challenges-opportunities/2244?redirect=1#overview_section

rimnet is a network for Global Heads of Regulatory Affairs and RIM IT professionals to create transformational enterprise solutions for Regulatory Information Management.

The theme for the rimnet Spring week two session is IDMP – How Ready Are You?

For further information, or to register your interest, please contact us at rimnet@navitaslifesciences.com

medtechnet is a new network for Safety, Regulatory, and Labeling leaders from pharma and medical technology companies to partner and shape NextGen Device and Combination Product Safety.

Following the successful inaugural launch of medtechnet in December 2021, and a further Spring meeting in March 2022 we are delighted to host our third Forum. Chaired by our PV and Medtech Networks Thought Lead, Dr. Latika Sharma, the theme for this event is ‘Spotlight on SaaMD’ and we will address the following:

• Software as a Medical Device – Regulations in Evolution
• Medical Device and Combination Product Inspections – How to be Inspection Ready

We are delighted to welcome Michelle Gondolfo, Associate, and Josefine Sommer, Senior Managing Associate from Sidley as speakers.

For further information or to register your interest in attending this meeting, please click here

rimnet is a network for Global Heads of Regulatory Affairs and RIM IT professionals to create transformational enterprise solutions for Regulatory Information Management.

The theme for the rimnet Spring week one session is Elevating RIM from Technology to Strategic Business Capability.

For further information, or to register your interest, please contact us at rimnet@navitaslifesciences.com

Navitas Clinical Research and Open Clinica invite you to our exclusive webinar titled “Digital registry platforms - Considerations for EHR/EDC Integration” to be conducted on Thursday, 23 June 2022.

Digital transformation and technology disruption are the next steps in improving operational excellence and speeding up clinical research in Life Sciences with EHR-EDC integration - but where should you begin?

Navitas Clinical Research and OpenClinical proudly present a webinar to show you the way with “Digital registry platforms - Considerations for EHR/EDC Integration”.

Electronic Health Record- Electronic Data Capture (EHR-EDC) integration holds great promise in reducing the load on trial investigators, while improving patient recruitment, accelerating trial execution, and increasing patient safety.

During the webinar, explore the art and science of registry platforms and learn

• What goes into Registry platform planning
• How EHR - EDC integration can accelerate your registry study
• How to obtain Optimized Digital Solutions through the data coordinating center

Learn from experts from Navitas Clinical Research and OpenClinica to get in-depth insights on digital registry platforms and considerations for EHR/EDC Integration.

Click here to REGISTER

pvtech is a network for Heads of Information Technology for PV departments, focused on increasing business value from technology investments.

The theme for the pvtech Spring week two session is PV Technology. This session will explore:

• PV Technology Landscape – does one size fit all?
• Harnessing intelligent automation in PV

For further information, or to register your interest, please contact us at pvtech@navitaslifesciences.com

Established in 2001, pvnet is a network for Heads of Safety of top 30 life sciences companies, invests in thought leadership to help shape future practices.

The theme for the pvnet Spring week two session is Reimagining PV Organizations. This session will explore:

• Reimaging PV organizations – commitment to reset
• Roundtable | Future-fit PV organization

For further information, or to register your interest, please contact us at pvnet@navitaslifesciences.com

Established in 2006, pvconnect is a network for Heads of Safety of mid-sized life science companies with a range of product portfolios including one or more of Pharma, Biologicals, Consumer, and Medical Devices.

The theme for the pvconnect Spring week two session is Talent, Territories, and Tools. This session will explore:

• People in PV – hiring, retention, and talent management strategies
• Local safety – sourcing models, oversight, and governance
• Tools and tech – risk and return on investment

For further information, or to register your interest, please contact us at pvconnect@navitaslifesciences.com

labelnet is a network for labeling leaders of large and mid-sized life sciences companies, with a specific focus on strategic aspects of the full life cycle of labeling.

The theme for the labelnet Spring week two session is Where next for Labeling? This session will explore:

• Future shifts on the horizon – the labeling response?
• Roundtable Session | Future-fit labeling organization
• What is the quantifiable value of labeling?

For further information, or to register your interest, please contact us at labelnet@navitaslifesciences.com

We are pleased that Navitas Data Sciences’ Shrishaila Patil will be producing his second PHUSE India Single Day Event (SDE) of the year as the India SDE Lead for 2022. We are also delighted to share that Navitas Data Sciences are committed as a PHUSE Media Sponsor for 2022. This event will be taking place virtually on Saturday 11 June. Chaired by representatives from Bayer and IQVIA, the event will look to explore Virtual Trial Design, Hybrid Trials, and Digital Data Collection Methodologies including Mobile Technology, Wearables, ePRO, and eCPA.

For further information about this event or to register your attendance, please visit the event website by clicking here.

Established in 2001, pvnet is a network for Heads of Safety of top 30 life sciences companies, invests in thought leadership to help shape future practices.

The theme for the pvnet Spring week one session is Will Safety Science master the data corridor? This session will explore:

• Future of Safety Science – what’s on the horizon?
• Spotlight on data, patients, digital, and regulatory
• Innovative applications of data science in BRM

For further information, or to register your interest, please contact us at pvnet@navitaslifesciences.com

labelconnect is a network for labeling leaders of large and mid-sized life sciences companies, with a specific focus on operational aspects of the full life cycle of labeling.

The theme for the labelconnect Spring week one session is Mastering the Challenges of Labeling Operations. This session will explore:

• How to leverage AdPromo – global process and roles
• Divergent quality models – impact on labeling

For further information, or to register your interest, please contact us at labelconnect@navitaslifesciences.com

pvtech is a network for Heads of Information Technology for PV departments, focused on increasing business value from technology investments.

The theme for the pvtech Spring week one session is PV Technology. This session will explore:

• PV Technology Landscape – does one size fit all?
• Harnessing intelligent automation in PV

For further information, or to register your interest, please contact us at pvtech@navitaslifesciences.com

labelnet is a network for labeling leaders of large and mid-sized life sciences companies, with a specific focus on strategic aspects of the full life cycle of labeling.

The theme for the labelnet Spring week one session is Spotlight on Patient Centric Labeling. This session will explore:

• Future shifts on the horizon – impact on patients?
• Use of RWE/RWD in labeling – what, how, and when?
• Patient led labeling – the direction of travel?

For further information, or to register your interest, please contact us at labelnet@navitaslifesciences.com

Established in 2006, pvconnect is a network for Heads of Safety of mid-sized life science companies with a range of product portfolios including one or more of Pharma, Biologicals, Consumer, and Medical Devices.

The theme for the pvconnect Spring week one session is Compliance and Connectivity. This session will explore:

• Big impact regulations – have we done enough?
• Contracts – chaos or calm?

For further information, or to register your interest, please contact us at pvconnect@navitaslifesciences.com

We are pleased that Navitas Life Sciences Labeling Networks Lead, Tris Nockles, will be presenting at Amplexor Life Sciences’ virtual conference, Be the Expert. The event will bring together leading subject matter experts and industry professionals from around the globe to discuss and exchange strategies to combat challenges confronting the life sciences industry.

With digital labeling already widely available across the globe Tris’ session titled The Future of Labeling – A Digital Reality? will explore the focus needed to ensure that both patients and healthcare professionals have access to the most up-to-date label. With a number of regulatory authorities exploring the possibility of delivering labeling through digital means, supported by a number of pilots already in place to validate if the provision of digital labeling can meet the needs of target audiences, we are seeing some countries moving beyond to implement within their regulations. So, just what is the reality of digital labeling for the future, and what does that mean for industry?

For further information about this event or to register your attendance, please visit the event website by clicking here.

If you would like to schedule a meeting with Tris to discuss how we may work together to support your labeling and artwork management then please click here.

The Navitas Data Sciences team are delighted to be a Gold Sponsor at PharmaSUG 2022. Our team of subject matter experts are looking forward to meeting with you at our exhibition booth.

As the global Functional Service Provider (FSP) division of Navitas Life Sciences, we have global solutions for all of your statistical programming, biostatistics, and data management needs.

If you would like to arrange to meet with a member of our team and learn how we can help you meet the future challenges of Data Requirements in your clinical trials then please click here.

For further information about the conference, please visit the event website by clicking here.

We are pleased to share that our CISO and AVP IT, Mr. Maharajan Suriyanarayanan, will be presenting as part of a Roundtable Discussion at the 11th Infosec Maestros 2022 Awards and Conference, which will take place virtually. The session, titled ‘Building Trust in the Digital World with Seamless Identity Management in the Pharma Industry’ forms part of Track 2’s agenda and will take place between 16:50 and 17:50 IST, bringing together industry leaders and innovators as they explore new ideas and innovative technologies.

For further information about this event or to register your attendance, please visit the event website: https://www.infosecmaestros.com/

We are pleased to share that our CISO and AVP IT, Mr. Maharajan Suriyanarayanan, will be presenting as part of a Panel Discussion at the Chennai Cloud and Datacenter Convention 2022. We are excited to be back at an in-person event with Maharajan contributing to a session, titled ‘Infrastructure and capacities on a stand-by mode’ which will take place between 14:30 – 15:15 IST and bring together industry leaders and innovators as they explore new ideas and innovative technologies.

For further information about this event or to register your attendance, please visit the event website: https://w.media/chennai-cloud-datacenter-convention-2022/

We are pleased that Navitas Clinical Research’s Client Partner, Deb Fenster, will be attending the upcoming BioNJ 12^th Annual BioPartnering Virtual Conference. The event has been designed to foster productive partnerships, create fruitful opportunities, grow the ecosystem, and bolster medical innovation.

For further information about this event or to register your attendance, please visit the event website by clicking here.

If you would like to schedule a meeting with Deb to discuss how we may work together to improve your clinical trial outcomes then please click here.

cmonet is a network for Chief Medical Officers, addressing strategic and governance topics within the remit of the CMO.

The theme for this event is Governance of Digital Health Platforms.

Please be advised that this is an invitation only event.

For further information please contact us at cmonet@navitaslifesciences.com

The Navitas Data Sciences team are delighted to be a platinum sponsor at PHUSE US Connect 2022. Our team of subject matter experts are looking forward to meeting with you at our exhibition booth.

Navitas Data Sciences is the global Functional Service Provider (FSP) division of Navitas Life Sciences providing highly skilled Data Manager, Statistical Programmers, and Biostatisticians for all your Biostatistics, Statistical Programming, and Data Management Needs.

If you would like to schedule time to meet with a member of our team at the event and discuss how we may help you to meet the future challenges of Data Requirements in your clinical trials, please click here.

For further information about the conference, please visit the event website by clicking here.

medtechnet is a new network for Safety, Regulatory, and Labeling leaders from pharma and medical technology companies to partner and shape NextGen Device and Combination Product Safety.

Following the successful inaugural launch of medtechnet in December, 2021 we are delighted to host our first Spring Forum. This event will be themed around EU Regulations for Medical Devices and Combination Products.

We are delighted to welcome Harminder Mudhar, Device and Digital Safety Principal at AstraZeneca as a speaker.

For further information or to register your interest in attending this meeting, please contact: networks@navitaslifesciences.com

Navitas Clinical Research invites you to our exclusive webinar titled “Don’t Treat Your Registry Like It’s a Clinical Trial!” to be conducted on Tuesday, 22 March 2022.

Registry studies are observational, and are retrospective while Clinical trials are investigational, they are prospective and dictate the treatment plan. This webinar will help you understand the difference between registries and clinical trials.

Key Highlights of the webinar:

• The importance of registries and their role in improving public health
• The need for a comprehensive strategy for patient registry
• Find out more about approaches like streamlining of cost efficiencies, minimal monitoring, site training, documents, and remote data collection
• Identify key considerations that will decide the outcome of successful registry studies - clearly defined goals, patient population, data collection etc.

Learn from our experts from Navitas Clinical Research to get in-depth insights on how to build a successful registry and how it is different from a clinical trial.

Click here to REGISTER

We are delighted that Navitas Data Sciences’ Shrishaila Patil will be producing his first PHUSE India Single Day Event in his new role as India SDE Lead for 2022. The event will be taking place on 19 March with a focus on Application of Open-source Technologies in Data Sciences and Analytics.

For further information about this virtual event or to register your attendance, please visit the event website by clicking here.

We will be taking part in Sparta Systems’ upcoming Asia-Pacific TrackWise User Group (TUG) 2022 virtual meeting taking place on 17 March. The event, for TrackWise customers, will address the following:

• Learn how to get more value from your TrackWise investment
• Hear about the latest solutions, product features, and benefits including updated on TrackWise and TrackWise Digital
• Understand how Artificial Intelligence (AI) acts as a transformational catalyst for quality management

For further information about the conference, please visit the event website: https://event.on24.com/wcc/r/3651824/81F4ED4BCEE6CFA42A93C778C38EDD4C?partnerref=social

pvindia is a network for PV leads of life sciences companies in the APAC region with Pharma, Consumer, Generics, or mixed portfolios. Launched in March, 2016 pvindia provides a neutral platform for pharmacovigilance leaders facing similar challenges to network, debate, compare performance, and share ideas on how to tackle the latest hot issues.

We are delighted to be hosting our 12th forum this Spring. The theme for this event is PV Enablers – Managing Complexity.

For further information, or to register your interest, please contact us at pvindia@navitaslifesciences.com

We are delighted that Navitas Data Sciences’ Shrishaila Patil is to take part in a Panel Discussion at the upcoming 15th Indian Society for Clinical Research (ISCR) Annual Conference. The panel discussion forms part of the Clinical Data Management (CDM) track and is titled: CDM through the crystal ball – What is in store in the coming decade?

The session will take place on Saturday 05 March between 16:10 – 17:10 IST. We hope that you can join for what we are sure will be an insightful discussion.

For further information about the conference, please visit the event website: https://www.iscr.org/Main_Conference.aspx

We are pleased to share that our CISO and AVP IT, Mr Maharajan Suriyanarayanan, will be presenting a session at the 7^th Innovative CIO Awards and Symposium 2022. The session, titled ‘Security Strategies for a Work-from-Anywhere World’ will explore new ideas and innovative technologies from industry leaders and innovators.

For further information about this event or to register your attendance, please visit the event website: https://cioawardsindia.com/

Navitas Life Sciences are delighted to be taking part in the Fierce JPM Week 2022.

If you are attending the event and would like to schedule a meeting with our Client Partner, Deborah Fenster, or our Business Development Manager, Rajesh Rao to learn how we can help you to improve your clinical trial outcomes, please click here.

For further information about the event, please visit the official website at: https://www.fiercejpmweek.com/

Navitas Life Sciences are delighted to be taking part in the BIO Partnering at JPM event.

If you are attending the event and would like to schedule a meeting with our Client Partner, Deborah Fenster, to learn how we can help you to improve your clinical trial outcomes, please click here

For further information about the event, please visit the official website at: https://www.bio.org/events/bio-partnering-jpm

Join our latest webinar, Risk Mitigation in Gene Therapy Clinical Development, as our subject matter expert, Dr. Atul Gupta, explores some of the barriers that are affecting gene therapy clinical trials, and the ways in which such challenges can be overcome.

The webinar will look at:

• Optimum Patient Population – Stratification factors to be considered
• Surrogate endpoints for changes to gene expression to accelerate approvals
• Pragmatic approaches to long term follow up
• Exclusion based on pre-existing neutralising antibodies
• DSMB considerations
• Adverse Events of special interest
• Patient centricity and retention

Speaker

Dr. Atul Gupta
Associate Vice President – Medical and Scientific Affairs
Navitas Life Sciences

To register for this webinar please click here

We are delighted to be launching medtechnet this December as a new network for Safety, Regulatory, and Labeling leaders from pharma and medical technology companies to partner and shape NextGen Device and Combination Product Safety.

Following discussions with the membership of our leading PV and Regulatory networks, we have identified an opportunity for cross-network collaboration to help drive device safety processes and organization. This new and innovative network will facilitate strategic thinking and peer exchange for members. This inaugural meeting will focus on:

• Overview of our ‘new’ network medtechnet
• Life cycle of Medical Device and Combination Products with applicable Regulations and Standards
• Medical Device and Combination Product Safety – Organizing for Success

For further information or to register your interest to attend this meeting please contact: networks@navitaslifesciences.com

We are pleased to share that our Senior Program Manager – IT Delivery, Saravanaperumal K, and our Principal Engagement Manager, Krishnan S, will be presenting a session titled ‘The role of the Quality Management System in enhancing efficiency and compliance’ at the upcoming virtual ISPE event, Malaysia Towards the Implementation of Pharma 4.0. This session will take place between 11:30 – 12:15 MST.

Speakers

Saravanaperumal K
Senior Program Manager, IT Delivery
Navitas Life Sciences

Krishnan S
Principal Engagement Manager
Navitas Life Sciences

For further information about this virtual event or to register your attendance, please visit the event website: https://ispemalaysia.org/pharma_4-0/

rimnet is a network for Global Heads of Regulatory Affairs and RIM IT professionals to create transformational enterprise solutions for Regulatory Information Management

The rimnet Autumn agenda for day two is themed around RIM in Action – where next? This session will focus on building out the vision for RIM in 2025, the roadmap to get there, as well as looking at the challenges.

For further information, or to register your interest, please contact us at rimnet@navitaslifesciences.com

labelconnect is a network for labeling leaders of large and mid-sized life sciences companies, with a specific focus on operational aspects of the full lifecycle of labeling.

The labelconnect Autumn agenda for day two is themed around Labeling Tracking – Start, Stop, Reset and will focus on the following:

• Day 0 and tracking
• Categories and timelines – evolution and where next?

For further information, or to register your interest, please contact us at labelconnect@navitaslifesciences.com

Established in 2001, pvnet is a network for Heads of Safety of top 30 life sciences companies, invests in thought leadership to help shape future practices.

The pvnet Autumn agenda for day two continues the theme PV Success Stories – Collaborate, Co-Create, and Co-Innovate and will focus on the following:

• Reimaging safety science organizations – enhancing efficiency, creating value
• Exploring the expanded PV eco-system – Epidemiology, Clinical Safety
• Innovations in signal and risk management

For further information, or to register your interest, please contact us at pvnet@navitaslifesciences.com

pvtech is a network for Heads of Information Technology for PV departments, focused on increasing business value from technology investments.

The pvtech Autumn agenda is themed around Digital PV Tools – a Tech Showcase and will focus on the following:

• AI enabled ICSR Automation/Alternative SDB
• Modern safety science systems
• Tools for efficiency: Ancillary activities (Inspections, PVA, AI, enabled literature, etc.)

For further information, or to register your interest, please contact us at pvtech@navitaslifesciences.com

rimnet is a network for Global Heads of Regulatory Affairs and RIM IT professionals to create transformational enterprise solutions for Regulatory Information Management

The rimnet Autumn agenda for day one is themed around Driving innovation in challenging times and will focus on the value of RIM as an integral business driver, delivering ROI from RIM, and the RIM Maturity Model.

For further information, or to register your interest, please contact us at rimnet@navitaslifesciences.com

labelnet is a network for labeling leaders of large and mid-sized life sciences companies, with a specific focus on strategic aspects of the full lifecycle of labeling.

The labelnet Autumn agenda for day two is themed around Accelerated Labeling – the new normal? and will focus on the following:

• Target labeling – defining what good looks like
• Accelerated submissions – readying labeling for competitive advantage?

For further information, or to register your interest, please contact us at labelnet@navitaslifesciences.com

Established in 2006, pvconnect is a network for Heads of Safety of mid-sized life science companies with a range of product portfolios including one or more of Pharma, Biologicals, Consumer, and Medical Devices.

The pvconnect Autumn agenda for day two is themed around Starting small and seeing success and will focus on the following:

• The latest RPA use cases
• Spotlight on signal detection
• Innovation in the PSMF
• Social media – scope for change?

For further information, or to register your interest, please contact us at pvconnect@navitaslifesciences.com

Navitas Life Sciences are delighted to be joining Sidley for the launch of their new network, mtlegal. Our PV Networks Lead, Dr. Latika Sharma, will be in attendance as a delegate. If you would like to arrange to meet with Latika, please reach us at contact@navitaslifesciences.com

The mtlegal benchmarking group is a new legal network for life sciences peers who work at MedTech companies. Through this new group, MedTech in-house counsel have the opportunity to benchmark their company's compliance with MedTech regulations against others in the industry. In particular, the group will discuss compliance with the EU Medical Devices Regulation (MDR) and the EU In Vitro Diagnostic Medical Devices Regulation (IVDR), as well as digital health. Participants will also have the opportunity to exchange views on best practices, engage in peer-to-peer discussion, and build connections to expand their professional network.

For further information about the network and the inaugural event, please contact Sidley directly at mtlegal@sidley.com

About mtlegal

mtlegal is a membership-based forum for in-house counsel at MedTech companies working on legal issues relating to EU medical device and IVD regulations. The members will be supported by regular benchmarking of performance and best practice sharing.

Navitas Life Sciences are pleased that Koushik Ganguly, Vice President, Clinical Operations, Navitas Life Sciences will be a panelist for a discussion titled Innovation through Crisis Development of Indigenous Vaccine for COVID-19 – An India Story taking place on Friday 12 November between 17:20 – 18:35 IST at the ISCR Mid-Year Virtual Autumn Conference.

If you would like to arrange to meet with Koushik, please reach us at contact@navitaslifesciences.com

For further information about the event please click here

labelconnect is a network for labeling leaders of large and mid-sized life sciences companies, with a specific focus on operational aspects of the full lifecycle of labeling.

The labelconnect Autumn agenda for day one is themed around Quality Management – the simpler the better and will focus on the following:

• Leveraging Quality Management and Compliance for efficiency
• Process and document simplification – the art of the possible

For further information, or to register your interest, please contact us at labelconnect@navitaslifesciences.com

Established in 2001, pvnet is a network for Heads of Safety of top 30 life sciences companies, invests in thought leadership to help shape future practices.

The pvnet Autumn agenda for day one is themed around PV success stories – Collaborate, Co-Create, and Co-Innovate and will focus on the following:

• Inspections and cross-functional collaborations
• Navigating the Global – EU – Local QPPV Networks
• Gaining efficiencies in PV agreements

For further information, or to register your interest, please contact us at pvnet@navitaslifesciences.com

pvtech is a network for Heads of Information Technology for PV departments, focused on increasing business value from technology investments.

The pvtech Autumn agenda is themed around Digital PV Tools – a Tech Showcase and will focus on the following:

• AI enabled ICSR Automation/Alternative SDB
• Modern safety science systems
• Tools for efficiency: Ancillary activities (Inspections, PVA, AI, enabled literature, etc.)

For further information, or to register your interest, please contact us at pvtech@navitaslifesciences.com

labelnet is a network for labeling leaders of large and mid-sized life sciences companies, with a specific focus on strategic aspects of the full lifecycle of labeling.

The labelnet Autumn agenda for day one is themed around Fueling Innovation – Digital and Beyond and will focus on the following:

• Digital and automation – powering the future of labeling
• Real World Data and beyond – building data capabilities

For further information, or to register your interest, please contact us at labelnet@navitaslifesciences.com

Established in 2006, pvconnect is a network for Heads of Safety of mid-sized life science companies with a range of product portfolios including one or more of Pharma, Biologicals, Consumer, and Medical Devices.

The pvconnect Autumn agenda for day one is themed Collaborate beyond Compliance and will focus on the following:

• Regulatory Intelligence – what does good look like?
• FDA IND Submissions – overcoming challenges
• Gaining efficiencies in PV agreements
• Cross-functional safety – best practices working with clinical and quality

For further information, or to register your interest, please contact us at pvconnect@navitaslifesciences.com

pvindia is a network for PV leads of life sciences companies in the APAC region with Pharma, Consumer, Generics, or mixed portfolios. Launched in 2016, pvindia provides a neutral platform for pharmacovigilance leaders facing similar challenges to network, debate, compare performance, and share ideas on how to tackle the latest hot issues.

We are delighted to be hosting our 11^th forum this autumn. The agenda for the event is themed around the Evolution of the PV Ecosystem and will focus on the following:

• Navigating the Global/Local QPPV Landscape
• Next Generation Safety Systems
• Post Pandemic Strategies

For further information, or to register your interest, please contact us at pvindia@navitaslifesciences.com

Navitas Data Sciences are pleased to be a Virtual Diamond Sponsor at the CDISC 2021 US Interchange.

Navitas Data Sciences is the Functional Service Provider (FSP) of Data Services for Navitas Life Sciences and has global solutions for all your biostatistics, statistical programming, and data management needs.

If you would like to arrange to meet with our team of experts and learn how we can help you to meet the future challenges of Data requirements in your clinical trials, please click here.

cmonet is a network for Chief Medical Officers, addressing strategic and governance topics within the remit of the CMO.

This roundtable meeting will explore Governance of Digital Health Platforms – with a spotlight on COVID-19 as an accelerator, strategies to building capability, and Health Authority expectations and impact.

Please be advised that this is an invitation only event.

For further information please contact us at cmonet@navitaslifesciences.com

Join our latest webinar, Enhance your Data Science toolkit with open source tools, as our subject matter experts explore how R can create efficiencies in data review and insight.

The webinar will explore the following key topics:

• Alternative solutions to unlocking valuable insights from rich and diverse data
• Statistics, Analytics, and Visualization – complementing the use of SAS with R
• Ensuring regulatory compliance when using open source software
  • A robust Risk Assessment Framework
  • Validation
  • Documentation
• Industry innovation and collaboration to develop better technology ecosystems

Speakers

Shrishaila Patil
Vice President, Statistical Programming
Navitas Data Sciences

Troy Ruth
Director, Clinical Reporting
Navitas Data Sciences

To register for this webinar, please click here

The Navitas Life Sciences team are delighted to be a sponsor at the SCDM Global Conference which is themed around Future Now: v2.021.

We look forward to meeting with you at our virtual exhibition booth where we can discuss how we can support you with data driven, patient centric, and efficient trials to help speed your product to market. If you would like to meet with our subject matter experts please click here to schedule a meeting.

For further information about the conference, please visit the event website at: https://scdm2021.org/

cmonet is a network for Chief Medical Officers, addressing strategic and governance topics within the remit of the CMO.

This roundtable meeting will explore Medical Affairs of the Future – with a spotlight on the use of social media, the value proposition and metrics, and the diversity of investigators and data collection.

Please be advised that this is an invitation only event.

For further information please contact us at cmonet@navitaslifesciences.com

Join our subject matter expert, Dr. Latika Sharma, PV Networks Lead at Navitas Life Sciences for our live webinar Shifting Sands of Pharmacovigilance – Pivot, Maneuver, Breakout as she explores the following key themes:

• Macro shifts shaping the future course of PV
• Industry’s response – data, digital, and skills
• What might PV in 2030 look like?

To register for this webinar, please click here

IDMP is fast becoming a reality. Join subject matter experts, Gary Wilson, Director at CorrIT and Raj Srinivasan, Executive Business Partner - Safety and Regulatory Technology – EMEA & APAC at Navitas Life Sciences for our live webinar as we explore the following key themes:

• The IDMP countdown has started
• Opportunities for Enhancing Regulatory Information Management
• A global approach to Regulatory compliance with associated guidance and timelines
• Technology that supports RIM and Harmonization of Global/Local Term Stores

To register for this webinar, please click here

The Navitas Data Sciences team are delighted to be a media sponsor at PHUSE Virtual US Connect 2021 – The Clinical Data Science Conference

Navitas Data Sciences is the global Functional Service Provider (FSP) division of Navitas Life Sciences providing highly skilled Data Manager, Statistical Programmers, and Biostatisticians for all your Biostatistics, Statistical Programming, and Data Management Needs.

For further information about the conference, please visit the event website at: https://www.phuse-events.org/attend/frontend/reg/thome.csp?pageID=2283&eventID=6

Navitas Data Sciences are pleased to be presenting at the upcoming PHUSE India Summer Single Day event. Our expert and Principal SAS Programmer, Mr Sasidhar Amilineni will be presenting a session between 12:30 and 13:00 IST on Real World Data/Real World Evidence providing an introduction as well as the associated challenges and best practices from a programmer’s perspective.

If you would like to arrange to speak with Sasidhar and learn how we can help you meet the future challenges of data requirements in your clinical trials then please click here

For further information please visit the event website: https://www.phuse-events.org/attend/frontend/reg/thome.csp?pageID=2841&ef_sel_menu=251&eventID=7

Navitas Clinical Research are delighted to be attending and exhibiting at the upcoming Outsourcing in Clinical Trials East Coast 2021 event. The event aims to explore effective strategies for outsourcing clinical trial operations to ensure that studies run smoothly and within budget.

If you would like to meet with our subject matter experts and learn how you can gain a competitive edge throughout your clinical development process then please click here to arrange a meeting.

For further information please visit the event website: https://www.arena-international.com/octeastcoast/

The Navitas Data Sciences team are delighted to be a Platinum Sponsor at the upcoming PharmaSUG US 2021 event. We look forward to meeting you at virtual exhibition booth where we are happy to discuss how our reliable statistical programmers can provide key data insights to power better decisions and drive successful outcomes for your organization.

Navitas Data Sciences is the global Functional Service Provider (FSP) division of Navitas Life Sciences providing highly skilled Data Manager, Statistical Programmers, and Biostatisticians for all your Biostatistics, Statistical Programming, and Data Management Needs.

For further information about the conference, please visit the event website at: https://www.pharmasug.org/us/index.html

Navitas Life Sciences is proud to be a Gold Sponsor at the Oracle Health Sciences – India event.

With over 50 Argus projects across the globe, we are proud to have been an Oracle Gold partner for over 10 years. Visit our booth to learn how we can help you transform your Pharmacovigilance efforts to deliver maximum value.

For further information about the event or to register please visit: https://www.oracle.com/in/industries/life-sciences/health-sciences-connect/sessions/

With the ever-increasing need to be compliant as well as audit ready, pharma companies are aspiring to automate and transform their QMS while, at the same time, taking advantage of the latest quality management technology and best practices.

We are delighted to be hosting a webinar with our client Natco Pharma and our partner Sparta Systems. Presented by R. Sridhar Reddy, Vice President – QA, Natco Pharma, this webinar will explore:

• Key industry trends and operational challenges impacting the Pharmaceutical industry
• Best practices for building a successful QMS business case and ensuring project success
• How Natco Pharma transformed their quality management operations by implementing TrackWise QMS

To register for this webinar please click here.

We are delighted to be presenting at the upcoming Uppsala Monitoring Centre WHODrug Webinar on Drug Data Coding Conventions. Our Clinical Data Co-ordinator II, Imtiayaz Khan, will deliver a presentation on Drug Data Coding Conventions, exploring processes and also providing an interactive session on the challenges in drug coding.

For further information about the event or to register please visit: https://www.who-umc.org/whodrug/training/webinars/

Navitas Life Sciences is proud to be a Gold Sponsor at the Oracle Health Sciences – Europe event.

With over 50 Argus projects across the globe, we are proud to have been an Oracle Gold partner for over 10 years. Visit our booth to learn how we can help you transform your Pharmacovigilance efforts to deliver maximum value.

For further information about the event or to register please visit: https://www.oracle.com/uk/industries/life-sciences/health-sciences-connect/sessions/

Navitas Life Sciences is proud to be a Gold Sponsor for the Oracle Health Sciences Connect event.

With over 50 Argus projects across the globe, Navitas Life Sciences is proud to have been an Oracle Gold Partner for over 10 years. Visit our booth to learn about how we can help transform your Pharmacovigilance efforts to deliver maximum value.

Click here to Learn more about the event and to Register

Navitas Data Sciences are pleased to be presenting at the upcoming PHUSE India Spring Single Day Event. Our expert, Shrishaila Patil, Vice President of Statistical Programming, will be presenting a session titled Clinical Data Standards in the era of Artificial Intelligence, Machine Learning, and Digital Transformation between 12:30 and 13:00 IST. The session will explore the following:

• Motivation - The Need of the Hour
• COVID-19 and the wave of Digital Transformation
• Why Data Standards?
• CDISC
• The Road Ahead
• Key Takeaways

If you would like to arrange to speak with Shrishaila and learn how we can help you meet the future challenges of data requirements in your clinical trials, then please click here

For further information or to register to attend, please visit the event website at: https://www.phuse-events.org/attend/frontend/reg/thome.csp?pageID=2841&ef_sel_menu=251&eventID=7

pvindia is a network for PV leads of life sciences companies in the APAC region with Pharma, Consumer, Generics, or mixed portfolios. Launched in March, 2016 pvindia provides a neutral platform for pharmacovigilance leaders facing similar challenges to network, debate, compare performance, and share ideas on how to tackle the latest hot issues.

We are delighted to be hosting our 10th forum this Spring. The agenda for this event is themed around Optimizing PV in a Post-Pandemic World and will focus on the following:

• Industry context
• Reflections on current Regulatory landscape
• PV Workforce of the Future

For further information, or to register your interest, please contact us at pvindia@navitaslifesciences.com

Navitas Data Sciences are pleased to be presenting at the upcoming CDISC webinar ‘Current and Forthcoming ADaM Publications’. Our expert, Luke Reinbolt, Lead Consultant and Clinical SAS Programmer Analyst will be presenting on ADNCA.

As the Functional Service Provider (FSP) of Data Services for Navitas Life Sciences, Navitas Data Sciences is a CDISC Registered Solutions Provider and Platinum Member delivering high quality data while ensuring regulatory compliance.

For further information or to register to attend, please visit the event website at: https://www.cdisc.org/events/education/webinars/2021/03/current-and-forthcoming-adam-publications

Navitas Clinical Research are delighted to be participating at the upcoming BioCapital Life Sciences Virtual Career Fair. We look forward to discussing the open opportunities that we have available

For further information or to register to attend, please visit the event website at: https://mdls.vfairs.com/

Navitas Life Sciences are pleased to be participating at the DIA Regulatory Submissions, Information, and Document Management Forum. The event brings together industry and regulatory stakeholders working across the scope of regulatory information to examine current data standards and requirements and effective regulatory information management approaches to align related systems. The forum will address four tracks: Regulatory Informatics Business, Regulatory Informatics Technology, Electronic Document Management, and Electronic Regulatory Submissions.

Our subject matter expert, Tris Nockles, will be presenting as part of Track 1: IRISS Forum Hot Topics on 10 February between 16:15 and 17:15 EST. Her session will explore the Electronic Product Information Topic Group Highlights.

If you would like to discuss Tris’ session in more detail, then please complete the form available here.

For further information, please visit the event website: https://www.diaglobal.org/en/conference-listing/meetings/2021/02/regulatory-submissions-information-and-document-management-forum#showcontent

Navitas Life Sciences are delighted to be taking part in the BIO Partnering at JPM event.

If you are attending the event and would like to schedule a meeting with our team of experts to learn how we can help you to improve your clinical trial outcomes, please click here.

For further information about the event, please visit the official website at: https://www.bio.org/events/bio-partnering-jpm

Navitas Data Sciences are delighted to be chairing a session at the upcoming SCDM India 2020 virtual event.

Our subject matter expert, Shrishaila Patil, Vice President of Statistical Programming, will be chairing the Track 3 Session titled SDTM and CDASH – Do we need both data standards? on Friday 04 December, 2020 between 14:00 and 15:30 IST.

If you would like to arrange to speak with Shrishaila and learn how we can help you to meet the future challenges of data requirements in your clinical trials, then please click here.

For further information, please visit the event website at: https://scdmindia.org/index.php

Navitas Data Sciences are pleased to be participating at the PHUSE EU Connect 2020 event.

Sid Kumar, AVP Statistical Programming, Navitas Data Sciences will be taking to the virtual podium to present a session title Clinical Graphs using the Python packages. This session will be available via the event’s on demand platform.

To schedule a meeting with our team of experts and learn how we can help you to meet the future challenges of data requirements in your clinical trials, please click here.

For further information, please visit the event website at: https://www.phuse-events.org/attend/frontend/reg/thome.csp?pageID=256&eventID=2

Kathy Dimeo, the President of KAI Research, Inc., a Navitas Life Sciences enterprise, will be sharing our clinical trial expertise and COVID-19 experiences in a conversation with Marty Rosendale, CEO of the Maryland Tech Council (MTC). The virtual event “Coffee with CEOs” is conducted by MTC and is free for members.

To register for the event, click here.

pvindia is a network for PV leads of life sciences companies in the APAC region with Pharma, Consumer, Generics, or mixed portfolios. Launched in March, 2016 pvindia provides a neutral platform for pharmacovigilance leaders facing similar challenges to network, debate, compare performance, and share ideas on how to tackle the latest hot issues.

We are delighted to be hosting our 9th forum this Spring. The agenda for this event is themed around PV Regulatory and Technology Excellence – A continued journey and will focus on the following:

• Industry context
• Reflections on current Regulatory landscape
• Operational excellence through PV Automation and Artificial Intelligence

Navitas Life Sciences are pleased to attend at the upcoming Bio Asia 2020 conference in Hyderabad, India.

BioAsia is a comprehensive framework dedicated to investors, researchers, start-ups, conglomerates in biotechnology, pharma, and to create business paradigms for the ever-evolving needs of the Lifesciences industry. The theme 'Today for Tomorrow 'explores the capabilities that Life sciences companies should invest in Today to thrive and create value Tomorrow.

The conference also presents an opportunity for corporates to interact with government agencies by providing valuable feedback and recommendations on regulatory compliances, investments, policymaking and reforms needed for the scope of Lifesciences.

If you would like to meet with our subject matter experts onsite, then please click here to schedule a meeting.

For further information about the event, please visit the event website here.

Navitas Life Sciences are pleased to be supporting Sidley’s upcoming Life Sciences College event ‘Inside the Minds of Regulators – Perspectives on EU Pharmaceutical and Medical Devices Law’

The event will bring together senior members of the European Commission and industry thought leaders. This interactive discussion will focus on a variety of topics, including the latest regulatory developments in the EU and the outlook for the life sciences industry as a whole. Hot topics to be addressed include:

• Update on recent key EU regulatory law developments
• IP incentives review and outlook for IP regulatory rights
• GDPR and EU data protection
• Regulatory aspects of EU competition law
• The changing landscape of medical devices and IVDs in Europe
• The World Health Organization’s fair pricing initiative
• Registries and real-world evidence

Navitas Life Sciences’ Latika Sharma, PV Networks Lead, will presenting at this event alongside Dr Alexander Natz, Secretary General, European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) in a session chaired by Maarten Meulenbelt, Partner, Sidley, on the topic of the ‘Emerging Role of Real World Evidence (RWE) in the Pharmaceutical Industry’. If you would like to arrange to meet with Latika please click here.

For further information regarding the event please contact Cristina Menéndez Ruiz at Sidley: cmenendezruiz@sidley.com

Navitas Life Sciences are pleased to attending and exhibiting at the upcoming ISCR Conference 2020 in Mumbai, India.

The Indian Society for Clinical Research (ISCR) is an association of Indian clinical research professionals registered under the Societies Registration Act (1860). The Society brings together all those who are engaged in clinical research activities in India and provides a forum for exchange of information and learning. The conference will be attended by over 500 delegates from medical institutions, ethics committees, biopharmaceutical industry, government, patient organizations and clinical research organizations.

The 2020 edition aims to brings the clinical research community together to learn, connect, and explore opportunities to drive excellence in clinical research.

If you would like to meet with our subject matter experts onsite then please click here to schedule a meeting.

For further information about the event, please visit the event website here.

Navitas Life Sciences will be present at the 38th JP Morgan Healthcare conference in San Francisco from the 13th to 16th of January. Meet our experts Ram Yeleswarapu (President) and Subhashri Sriram (Chief Financial Officer) to learn how Navitas Life Sciences can enable you to drive better outcomes for your business.

For further information about the event, please visit the event website here

Navitas Life Sciences are pleased to attending and exhibiting at Booth #1 at the upcoming 14th Biosimilars Congregation, 2019 in Mumbai, India.

The event will bring together leading industry experts to discuss latest issues related to development, manufacturing to commercialization - The current landscape, legal, regulatory, funding, challenges, business models and go-to-market challenges related to Biosimilars in India.

If you would like to meet with our subject matter experts onsite then please click here to schedule a meeting.

For further information about the event, please visit the event website here.

Join our Safety experts as they look at how you can transform your End-to-End Safety Operations for greater visibility and control by leveraging leading edge technology.

This webinar will look at:

• How Navitas Life Sciences can provide absolute transparency and control of your safety operations
• How Oracle Argus enables greater flexibility, data security and regulatory compliance
• Why Navitas Life Sciences is best suited to take care of your clinical trial and post-marketing safety requirements

Presenters:

• Raj Srinivasan, Executive Business Partner – Safety & Regulatory Technology (EMEA & APAC) at Navitas Life Sciences
• Michael Braun-Boghos, Senior Director Safety Strategy at Oracle Health Sciences Business Unit

To register for this webinar, please click here.

Navitas Life Sciences are pleased to attending and exhibiting at booth #12 at the upcoming Clinical Operations in Oncology Trials Europe 2019. The event will bring together executives responsible for clinical operations in oncology.

If you would like to meet with our subject matter experts onsite then please contact us at marketing@navitaslifesciences.com to arrange a meeting.

For further information about the event, please visit the event website here.

Navitas Life Sciences are pleased to attending and exhibiting at Booth 80 at the upcoming Clinical Trials Europe conference. The event aims to drive innovation, collaboration, and new drug development; bringing together clinical trials stakeholders to swap insights, share knowledge, and gain new perspectives.

If you would like to meet with our subject matter experts onsite to discuss how we can transform your Clinical Trials through our Insights and Data-Driven Clinical Solutions that are customized to address your critical challenges then please contact us at marketing@navitaslifesciences.com to arrange a meeting.

For further information about the event, please visit the event website here.

labelconnect is a network for labeling leaders of large and mid-sized life sciences companies, with a specific focus on operational aspects of the full lifecycle of labeling.

The labelconnect November agenda is themed around Intelligent Labeling – processes by design and will focus on the following:

• Labeling implementation teams – role remit and interfaces, define decision making in governance
• Focus on inspections – experiences including with respect to outsourcing R&Rs
• Back translations – measuring the balance between effort and value

For further information, or to register your interest, please contact us at labelconnect@navitaslifesciences.com

Established in 2006, pvconnect is a network for Heads of Safety of mid-sized life science companies with a range of product portfolios including one or more of Pharma, Biologicals, Consumer, and Medical Devices.

The pvconnect November agenda will address:

• Latest regulatory context - member responses to regulations and strategies for inspections
• The PV workforce – resource, capabilities, and vendors – how do we ensure we have the right people in the right roles?
• QMS, training and SOPs – best practices and future focus
• Automation of analytics in PV…continued – Experience share of live projects

For further information, or to register your interest, please contact us at pvconnect@navitaslifesciences.com

labelnet is a network for labeling leaders of large and mid-sized life sciences companies, with a specific focus on strategic aspects of the full lifecycle of labeling.

The labelnet November agenda is themed around Intelligent Labeling – realizing our full potential and will focus on the following:

• Early involvement, framework, TPP, TPLs interface between labeling and regulatory strategy leader
• Talent and capability – map key roles (early strategists, digital data science, labeling intelligence, vendor management) and feedback from working group
• Patients in labeling – patient centricity, RWE alternative data sources. Apps are devices in combination with medicinal products
• Digital and automation – mapping the end-to-end process looking for opportunities for automation

For further information, or to register your interest, please contact us at labelnet@navitaslifesciences.com

pvtech is a network for Heads of Information Technology for PV departments, focused on increasing business value from technology investments.

The pvtech November agenda will address:

• The PV Safety Database: implementation and NextGen SDB
• PV Technology beyond the Safety Database: right sourcing for emerging technologies and technology deep dive

For further information, or to register your interest, please contact us at pvtech@navitaslifesciences.com

rimnet is a network for Global Heads of Regulatory Affairs and RIM IT professionals to create transformational enterprise solutions for Regulatory Information Management.

The rimnet November agenda is themed around NextGen RIM – focus on structured data and will address:

• Latest regulatory and industry context
• Structured data elements through the entire value chain – connecting structured data elements to the patient
• Revisit and update RIM Maturity Model – focus on process
• RMM – candidate for industry standard approach
• Grandmaster File V2

For further information, or to register your interest, please contact us at rimnet@navitaslifesciences.com

Established in 2001, pvnet is a network for Heads of Safety of top 30 life sciences companies, invests in thought leadership to help shape future practices.

The pvnet November agenda is themed around NextGen PV – gearing up for success and will focus on the following:

• Latest regulatory and industry context
• Regulatory intelligence and HA influencing
• PV automation and analytics... a continued conversation
• How to gear up – talent, capability, and partnering
• Community way forward

For further information, or to register your interest, please contact us at pvnet@navitaslifesciences.com

labelconnect is a network for labeling leaders of large and mid-sized life sciences companies, with a specific focus on operational aspects of the full lifecycle of labeling.

The labelconnect November agenda is themed around Intelligent Labeling – processes by design and will focus on the following:

• Labeling implementation teams – role remit and interfaces, define decision making in governance
• Focus on inspections – experiences including with respect to outsourcing R&Rs
• Back translations – measuring the balance between effort and value

For further information, or to register your interest, please contact us at labelconnect@navitaslifesciences.com

labelnet is a network for labeling leaders of large and mid-sized life sciences companies, with a specific focus on strategic aspects of the full lifecycle of labeling.

The labelnet November agenda is themed around Intelligent Labeling – realizing our full potential and will focus on the following:

• Early involvement, framework, TPP, TPLs interface between labeling and regulatory strategy leader
• Talent and capability – map key roles (early strategists, digital data science, labeling intelligence, vendor management) and feedback from working group
• Patients in labeling – patient centricity, RWE alternative data sources. Apps are devices in combination with medicinal products
• Digital and automation – mapping the end-to-end process looking for opportunities for automation

For further information, or to register your interest, please contact us at labelnet@navitaslifesciences.com

pvtech is a network for Heads of Information Technology for PV departments, focused on increasing business value from technology investments.

The pvtech November agenda will address:

• The PV Safety Database: implementation and NextGen SDB
• PV Technology beyond the Safety Database: right sourcing for emerging technologies and technology deep dive

For further information, or to register your interest, please contact us at pvtech@navitaslifesciences.com

Established in 2006, pvconnect is a network for Heads of Safety of mid-sized life science companies with a range of product portfolios including one or more of Pharma, Biologicals, Consumer, and Medical Devices.

The pvconnect November agenda will address:

• Latest regulatory context - member responses to regulations and strategies for inspections
• The PV workforce – resource, capabilities, and vendors – how do we ensure we have the right people in the right roles?
• QMS, training and SOPs – best practices and future focus
• Automation of analytics in PV... continued – Experience share of live projects

For further information, or to register your interest, please contact us at pvconnect@navitaslifesciences.com

rimnet is a network for Global Heads of Regulatory Affairs and RIM IT professionals to create transformational enterprise solutions for Regulatory Information Management.

The rimnet November agenda is themed around NextGen RIM – focus on structured data and will address:

• Latest regulatory and industry context
• Structured data elements through the entire value chain – connecting structured data elements to the patient
• Revisit and update RIM Maturity Model – focus on process
• RMM – candidate for industry standard approach
• Grandmaster File V2

For further information, or to register your interest, please contact us at rimnet@navitaslifesciences.com

Established in 2001, pvnet is a network for Heads of Safety of top 30 life sciences companies, invests in thought leadership to help shape future practices.

The pvnet November agenda is themed around NextGen PV – gearing up for success and will focus on the following:

• Latest regulatory and industry context
• Regulatory intelligence and HA influencing
• PV automation and analytics... a continued conversation
• How to gear up – talent, capability, and partnering
• Community way forward

For further information, or to register your interest, please contact us at pvnet@navitaslifesciences.com

Navitas Life Sciences are pleased to be attending the upcoming Outsourcing in Clinical Trials Nordics 2019 event. This event will explore how to accelerate trial timelines and cut costs by reducing inefficiencies in global supply chains.

If you would like to meet with our subject matter experts onsite to learn how you can gain a competitive edge throughout your clinical development process then please contact us at marketing@navitaslifesciences.com to arrange a meeting.

For further information about the event, please visit the event website here.

pvindia is a network for PV leads of life sciences companies in the APAC region with Pharma, Consumer, Generics, or mixed portfolios. Launched in March, 2016 pvindia provides a neutral platform for pharmacovigilance leaders facing similar challenges to network, debate, compare performance, and share ideas on how to tackle the latest hot issues.

We are delighted to be hosting our 8th forum this autumn. The agenda is themed around Empowering PV operations with proactive regulatory compliance and NextGen PV automation and will focus on the following:

• Global & Domestic Regulatory Updates
• Taking Regulatory compliance to the next level
• Achieving operational excellence through PV Automation and Artificial Intelligence (AI)

For further information, or to register your interest, please contact us at pvindia@navitaslifesciences.com

Navitas Life Sciences are pleased to be attending the upcoming Outsourcing in Clinical Trials DACH 2019 event. The event will explore the operational challenges facing clinical development in Germany, Austria, and Switzerland.

If you would like to meet with our subject matter expert onsite to learn how you can gain a competitive edge throughout your clinical development process then please contact us at marketing@navitaslifesciences.com to arrange a meeting.

For further information about the event, please visit the event website here.

Navitas Life Sciences are pleased to be attending the upcoming UK Biotech Summit. The event will look at the evolving design of cancer drug trials, the ways in which oncology studies will be adapted in the coming years, and the influence that will have on developers in general, regardless of disease.

If you would like to meet with our team onsite to discuss how you can transform your clinical trials through our insights and data-driven clinical solutions that are customized to your critical challenges, then please contact us at marketing@navitaslifesciences.com to arrange a meeting.

For further information about the event, please visit the event website here

Navitas Life Sciences are pleased to be exhibiting at booth #605 at the upcoming SCDM 2019 conference; celebrating the 25th anniversary of SCDM. If you would like to meet our subject matter experts to discover how you can transform your Clinical Trials through our Insights and Data Driven Clinical Solutions that are customized to address your critical challenges then please click here to schedule a meeting.

For further information about the conference, please visit the event website here

Meet with our Regulatory experts at RAPS booth 345 and leverage our experience to improve your Regulatory strategy and processes.

We are proud to have more than 70,000 regulatory submissions under our belt. At Navitas Life Sciences we have the insights to support the regulatory end-to-end lifecycle management across the entire value chain of the drug and device regulatory environment.

If you would like to arrange a meeting with a member of our team then please click here.

For further information about the meeting, please visit the event website here

Navitas Life Sciences’ Global Head for Generics, Dr Ayaaz Khan will be one of the speakers at the ‘The Economic Times L.I.F.E. Summit’ (Life Sciences Industry Forum for Excellence), taking place on 23rd August 2019 at Taj Krishna, Hyderabad contributing to the theme ‘Product Innovation & Development – Biosimilars - The race is on!’

For further information about ‘The Economic Times L.I.F.E. Summit’ (Life Sciences Industry Forum for Excellence), please visit the event website here

Navitas Life Sciences are pleased to be attending and presenting at Sidley’s pvlegal Biannual Meeting. The event will include hot topics in Pharmacovigilance (US and EU), benchmarking trends, and practical case studies on industry issues.

Navitas Life Sciences’ Zuby Okemefuna, Senior Consultant, will co-present a case study, Safety Information Communication Tool, with Todd Rudo and Kevin Tynan of CSL Behring. If you would like to arrange to meet with Zuby please contact us at marketing@navitaslifesciences.com

About pvlegal

pvlegal is a membership based forum for in-house counsel and compliance personnel at pharmaceutical companies working on pharmacovigilance issues in the Life Sciences sector. This is supported by regular benchmarking of member performance and best practice sharing in the areas of drug safety. Sidley Austin LLP serves as counsel to pvlegal. Additional support and sponsorship is provided by Navitas Life Sciences. For further information please contact pvlegal@sidley.com

Navitas Life Sciences’ are delighted to be exhibiting at booth #954 the DIA 2019 Global Annual Meeting.

If you would like to meet with our onsite team to learn how you can gain a competitive edge throughout your clinical development process then please click here

For further information about the conference, please visit the event website at: https://www.diaglobal.org/en/flagship/dia-2019