End-to-End Labeling is one of the most complex cross-functional processes within the pharmaceutical industry. In order to meet regulatory expectations and ensure future success, it is necessary to develop a robust, scalable, and harmonized solution for the global labeling capability. Join our subject matter experts as they examine how leveraging technology can improve outcomes across your End-to-End Labeling processes.

• Harnessing labeling technologies as a game changer for end-to-end process optimization and tangible outcomes
• Exploring conceptual models – moving from current state architecture towards a future state for labeling technology nirvana
• Extracting business value from your technology investments: moving from retrospective tracking to predictive analytics

Presenters:
Denis Fung, Head of Consulting Europe, Navitas Life Sciences
Zuby Okemefuna, Senior Consultant, Navitas Life Sciences

To register for this webinar, please click here.

Navitas Life Sciences’ Chief Growth Officer, Dr. Krishnan Rajagopalan, will be presenting at the 8th Annual Regulatory Operations and Submissions conference:

Tuesday 11 June, 2019 11:00 – 11:45: Partnership Models for Global Submissions and Publishing

The session will explore:

• Industry challenges and priorities
• Benchmark metrics and insights
• Key objectives in Regulatory Affairs, Submissions/Publishing
• Partnership Model – Scope | Unit Pricing | Sample KRAs | Governance | Learnings

Navitas Life Sciences’ Client Partner, Vencislav Cheshmedzhiev, will be attending the 13^th Biosimilars Congregation.

If you would like to meet with Vencislav to find out more about our Biosimilars capabilities and discuss how you can leverage OneClinical, our optimized eClinical and analytics platform or comprehensive trial oversight, faster decisions, and better outcomes then please contact marketing@navitaslifesciences.com

For further information about the conference, please visit the event website at: https://www.virtueinsight.com/pharma/13th-Biosimilars-Congregation-2019/

labeltech is a network for Regulatory or Labeling IT professionals focused on exploring E2E labeling technologies to improve processes and increase business value.

The labeltech June agenda is themed around 'Streamlining the future with technology' and will focus on the following:

• Overarching systems
• Digital health
• SCA, Automation, Artificial Intelligence, and Apps

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 meeting agenda will address

• Latest regulatory context: member responses to regulations and strategies for inspections
• Automation experience share - lessons learned and next steps
• Impact on PV organisation and capabilities – spotlight on interaction with outsourcing
• Modern metrics

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

The meeting agenda will address:

• EVDAS - updates and learnings
• Safety database upgrades - top tips for success
• PV technology landscape - beyond the Safety Database
• Mapping tools and gaps for safety science

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 June agenda is themed around 'Intelligent Labeling' and will focus on the following:

• Early involvement, framework, TPP, and TPLs
• Patient centricity and RWE
• Competencies and resources - talent management and offshoring

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 June agenda is themed around 'Optimizing the E2E Labeling Process' and will focus on the following:

• Interfaces with PV and SC
• Vendor and partner management
• QC, labeling standard, and how to track

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 June agenda is themed around 'PV Evolution - spotlight on analytics, alliances, and agility'.

• Latest regulatory and industry context with benchmark highlights
• Digital journey - spotlight on PV analytics and data
• Alliances in action - vendors, affiliates, academia, and regulators
• PV budgets and productivity measures in a digital era

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 June agenda is themed around 'New solutions to existing challenges' and will focus on the following:

• Technology: vendor showcase; Artificial Intelligence, Automations, and RIM; SCA
• Process: Data modelling/data standards - establish core data model; Process engineering to bring on RIM; Supply Chain Management and Regulatory Operations Management
• Strategy: Cross functional interactions; System, Clinical and RA interactions; Bridge CMC, Clinical, and Regulatory
• Regulations: Regulatory intelligence, IDMP

Navitas Life Sciences will be present at the 8th annual Global Pharma Regulatory Summit from 29 -31 May 2019 at The Lalit Mumbai, India. Raj Srinivasan, VP – Business Partner, Safety & Regulatory will be speaking on the topic "Journey towards regulatory excellence by leveraging technology" on Day 3 of the summit. pharmaREADY will also be demonstrated at the summit.

The 8th Edition of Global Pharma Regulatory Summit is a platform where key leaders and experts of regulatory affairs, compliances, quality assurance and policy makers discuss the current trends and challenges in global regulatory landscape. The forum will discuss the latest challenges in the regulatory environment and examine the impact of new initiatives for emerging markets, review the global perspective of regulatory system and understand how companies world over will revamp pharma regulatory strategies.

For further information, or to register your interest, please contact us at: https://navitaslifesciences.pages.salesfusion.com/8th-Annual-Global-Pharma-Regulatory-Summit-2019

labeltech is a network for Regulatory or Labeling IT professionals focused on exploring E2E labeling technologies to improve processes and increase business value.

The labeltech May agenda is themed around 'Streamlining the future with technology' and will focus on the following:

• Overarching systems
• Digital health
• SCA, Automation, Artificial Intelligence, and Apps

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 May agenda is themed around 'Intelligent Labeling' and will focus on the following:

• Early involvement, framework, TPP, and TPLs
• Patient centricity and RWE
• Competencies and resources - talent management and offshoring

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 May agenda is themed around 'Optimizing the E2E Labeling Process' and will focus on the following:

• Interfaces with PV and SC
• Vendor and partner management
• QC, labeling standard, and how to track

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 meeting agenda will address

• Latest regulatory context: member responses to regulations and strategies for inspections
• Automation experience share - lessons learned and next steps
• Impact on PV organisation and capabilities - spotlight on interaction with outsourcing
• Modern metrics

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 May agenda is themed around 'New solutions to existing challenges' and will focus on the following:

• Technology: vendor showcase; Artificial Intelligence, Automations, and RIM; SCA
• Process: Data modelling/data standards - establish core data model; Process engineering to bring on RIM; Supply Chain Management and Regulatory Operations Management
• Strategy: Cross functional interactions; System, Clinical and RA interactions; Bridge CMC, Clinical, and Regulatory
• Regulations: Regulatory intelligence, IDMP

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 May agenda is themed around 'PV Evolution - spotlight on analytics, alliances, and agility'

• Latest regulatory and industry context with benchmark highlights
• Digital journey – spotlight on PV analytics and data
• Alliances in action – vendors, affiliates, academia, and regulators
• PV budgets and productivity measures in a digital era

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

The meeting agenda will address:

• EVDAS - updates and learnings
• Safety database upgrades - top tips for success
• PV technology landscape - beyond the Safety Database
• Mapping tools and gaps for safety science

Navitas Life Sciences’ Client Partner, Dr. Peder Seglund, will be in attendance at the Sparta Connection 2019 event and will speak to Quality Professionals about TrackWise support, web services, and Quality Connect Integrations.

The 2019 conference is themed around ‘Making Digital Quality and Reality’. We are proud to have completed one of the first TrackWise digital implementations in the industry. If you would like to meet with Dr. Seglund to learn how you can optimize your TrackWise investment, then please contact marketing@navitaslifesciences.com

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

Navitas Life Sciences are pleased to be attending Sidley’s ctlegal Biannual Meeting. This interactive meeting will include hot topics in clinical trials (EU and USA), benchmarking trends, and practical case studies on industry issues. Agenda topics include:

• Investigator Sponsored Research
• Clinical Trial Agreements
• Post Approval Access
• Subject Injuries and Reporting

Navitas Life Sciences’ Client Partner, Piet Smet, will be in attendance at the 9th Annual Outsourcing in Clinical Trials Europe 2019 event. The conference will discuss ever-pressing partnership and outsourcing challenges as well as having a dedicated track to address clinical trial technology and data.

If you would like to meet with Piet Smet to find out more about our services and discuss how you can leverage OneClinical, our optimized eClinical and analytics platform offering comprehensive trial oversight and enabling fast decisions, then please contact marketing@navitaslifesciences.com

For further information about the conference, please visit the event website at: http://www.arena-international.com/octeurope/

John D'Antonio, Global Head of Consulting, Navitas Life Sciences, will provide a case study on how companies are moving to the Cloud to reduce costs, expedite implementations and/or upgrades, and ensures data security and privacy at the Oracle Health Sciences Connect 2019 Conference in Philadelphia, Pennsylvania on Wednesday, April 10, 2019, at 9:15am EST.

To meet with our experts at the conference, please visit click here.

Navitas Life Sciences are both speaking and exhibiting at the eRegulatory Summit. The event will bring together the innovators of the changing face of Information Management and eSubmissions to look at telematics, RIM, eCTD, IDMP, and filing variations – providing actionable insights to improve regulatory strategy.

On Monday 08 April, 2019 between 10:20 – 10:55, Navitas Life Sciences’ Global Head of Regulatory and Safety, Marty Boom, will be presenting a session titled: ‘Strategic progression to RIM excellence – transforming information into intelligence and insights’. This session will:

• RIM Maturity Model: Building a single, consistent, and reliable source of truth
• Integrating processes to drive value across the RIM landscape
• Turning Regulatory information into intelligence and insights to enhance integrated processes

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

Navitas Life Sciences’ Louise Tan, Senior Consultant – PV Thought Lead, will be in attendance at this event. If you would like to arrange to meet with Louise please contact us at marketing@navitaslifesciences.com

About pvlegal
pvlegal is a specialized forum for in-house counsel and compliance personnel working on drug and device safety issues in the Life Sciences sector. 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

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 7^th forum, which will include:

• Context and Regulatory update
• PV today – moving towards operational excellence
• Automation and how it fits into the PV evolution

Join our subject matter expert as she examines the role of Automation, Analytics and AI within PV organizations. The current state of the industry is at an inflection point with stakeholders investing in new and collaborative ways of working.

This webinar, the first in a series on NextGen PV Technology Transformation, will discuss the building blocks needed to develop an early adoption strategy for successful Transformation.

Using illustrative case studies and industry benchmarks we will explore:

• A metrics driven approach to automation – the what, when, and how
• A value driven approach to developing an analytics program
• An efficiency driven approach to adoption of AI technologies

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 look at how the latest legal and regulatory developments in EU law will affect companies operating in the Life Sciences space. It will bring together senior and former members of the European Commission, the European Medicines Agency, the Dutch Medicines Evaluation Board, the Swiss Agency for Therapeutic Products, the US Food and Drug Administration, as well as representatives from the regulatory and business community to address key issues.

Panel discussions will cover clinical trials, pharmacovigilance, orphan drugs, new pathways to marketing authorizations, falsified medicines, pharmaceutical incentives, transparency on pricing, pharmacy compounding, advanced therapy medicinal products (ATMPs), fees, off-label use, biosimilars, medical devices and Brexit among other topics.

Navitas Life Sciences’ Piet Smet, Client Partner and Sara Giadrossi, Networks Operations Manager, will be in attendance at this event. If you would like to arrange to meet with Piet or Sara, please contact us at marketing@navitaslifesciences.com

For more information, visit here

Navitas Life Sciences are pleased to be attending Sidley’s Women’s Life Sciences Network event ‘EU/US Perspectives on Innovation and Market Access’

The event will feature a discussion with Kristine Peers, General Counsel, European Federation of Pharmaceutical Industries (EFPIA) and Rebecca Wood, Partner, Sidley and Former Chief Counsel, Food and Drug Administration (FDA).

Kristine will focus on the challenging environment in Europe for the innovative pharmaceutical business, reflecting on the ongoing debate around patient access, IP incentives and innovation. Becky will discuss inflection points at the new FDA, as the agency modernizes its approach to biopharmaceutical innovation and competition.

Navitas Life Sciences’ Sara Giadrossi, Networks Operations Manager, will be in attendance at this event. If you would like to arrange to meet with Sara please contact us at marketing@navitaslifesciences.com

For further information about the event please contact Cristina Menendez Ruiz at cmenendezruiz@sidley.com

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

This event, hosted by the KOWAL Foundation, will look at IT software solutions for verifying the authenticity of medicines in accordance with the Delegated Regulation 2016/161.

Navitas Life Sciences’ Vice President and Business Partner for Regulatory and Safety Technology, Varadarajan Srinivasan, will be in attendance showcasing our EU FMD Module for traceREADY

For further information or to register your attendance, please visit the KOWAL Foundation website here

To arrange to meet with a member of our team please contact marketing@navitaslifesciences.com

Navitas Life Sciences will conduct a Thought Leadership podium presentation at Partnerships in Clinical Trials Europe. Our Chief Growth Officer, Dr. Krishnan Rajagopalan together with Dr. Niranjan Rao, Vice President Clinical Development at Asana BioSciences will be presenting the session on Wednesday 28 November, 2018 at 15:00.

Leveraging AI based platform and analytics for RBM, CM/RM, trial operations, and improved outcomes

With the industry pursuing several new models transforming Clinical Trial operations, Dr. Rajagopalan and Dr. Rao will look to address some of the key topics below as part of the discussion:

• An Overview of the Challenges in the Clinical Trials Landscape and the Drivers towards Innovations
• Leveraging Operating Models - Risk Based Monitoring (RBM), Quality by Design (QdB), and CM/RM
• Technology developments and considerations – AI, automation, and digital approaches
• Case study: ‘Implementing innovative technology’ – looking at how Navitas Life Sciences’ OneClinical (an integrated clinical enterprise platform) is leveraged to optimize data integration, analytics and data visualization and some pivotal decisions on the study

Join our subject matter experts as they explore the topic of Clinical and Regulatory data convergence and how you can improve information flow to increase enterprise value.

This webinar will explore:

• Industry challenges related to content management and data re-use across the drug development life-cycle
• Evolution of life sciences data and technologies that support clinical and regulatory data convergence
• Clinical and regulatory touch points and opportunities to improve data flow and information management

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

We are delighted to offer a two day meeting this November, to include a unique one day session across our portfolio of PV and Regulatory networks. Our aim is to:

• Provide a rich and practical perspective on the latest technology innovations – how automation and analytics are changing our world
• Host a deep dive discussion on the cross functional interfaces across the overarching (patient to patient) E2E PV and labeling process
• Ensure focused discussion on hot topics emerged at recent forums and the latest industry benchmark data

• The latest RIM context and Regulatory updates
• Implementing risk based global processes
• Systems integration

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 offer a two day meeting this November, to include a unique one day session across our portfolio of PV and Regulatory networks. Our aim is to:

• Provide a rich and practical perspective on the latest technology innovations – how automation and analytics are changing our world
• Host a deep dive discussion on the cross functional interfaces across the overarching (patient to patient) E2E PV and labeling process
• Ensure focused discussion on hot topics emerged at recent forums and the latest industry benchmark data

• The latest Regulatory insights
• PV automation
• PV workforce of the future
• Vendors, value, and how to measure success

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.

We are delighted to offer a two day meeting this November, to include a unique one day session across our portfolio of PV and Regulatory networks. Our aim is to:

• Provide a rich and practical perspective on the latest technology innovations – how automation and analytics are changing our world
• Host a deep dive discussion on the cross functional interfaces across the overarching (patient to patient) E2E PV and labeling process
• Ensure focused discussion on hot topics emerged at recent forums and the latest industry benchmark data

• Regulatory insights and Reference Labeling
• Development Labeling – what does good look like?
• How to build a business case for strategic labeling

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.

We are delighted to offer a two day meeting this November, to include a unique one day session across our portfolio of PV and Regulatory networks. Our aim is to:

• Provide a rich and practical perspective on the latest technology innovations – how automation and analytics are changing our world
• Host a deep dive discussion on the cross functional interfaces across the overarching (patient to patient) E2E PV and labeling process
• Ensure focused discussion on hot topics emerged at recent forums and the latest industry benchmark data

• Regulatory insights and Reference Labeling
• Labeling for different sectors: Devices, Combination Products, Biosimilars, and Consumer Products
• Next generation competencies and resourcing

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

We are delighted to offer a two day meeting this November, to include a unique one day session across our portfolio of PV and Regulatory networks. Our aim is to:

• Provide a rich and practical perspective on the latest technology innovations – how automation and analytics are changing our world
• Host a deep dive discussion on the cross functional interfaces across the overarching (patient to patient) E2E PV and labeling process
• Ensure focused discussion on hot topics emerged at recent forums and the latest industry benchmark data

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 offer a two day meeting this November, to include a unique one day session across our portfolio of PV and Regulatory networks. Our aim is to:

• Provide a rich and practical perspective on the latest technology innovations – how automation and analytics are changing our world
• Host a deep dive discussion on the cross functional interfaces across the overarching (patient to patient) E2E PV and labeling process
• Ensure focused discussion on hot topics emerged at recent forums and the latest industry benchmark data

• Regulatory update
• Vendor management – new perspectives
• Benefit Risk management – future focus
• Leveraging data and technology

The Falsified Medicines Directive (FMD) introduces harmonized European measures to prevent falsified medicines from entering the legal supply chain. Companies that manufacture, sell or dispense drugs in the European Union have until February 9, 2019 to comply.

Are you READY?

Join us as we discus how you can speed up your efforts to meet the EU FMD deadline with innovative industry leading technology.

Presenters:
Govind Srinivasan, Vice President, Technology, Navitas Life Sciences

Bill Fletcher, Managing Partner, Pharma Logic Solutions, LLC

To register for this webinar, please click here.

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.

We are delighted to offer a two day meeting this November, to include a unique one day session across our portfolio of PV and Regulatory networks. Our aim is to:

• Provide a rich and practical perspective on the latest technology innovations – how automation and analytics are changing our world
• Host a deep dive discussion on the cross functional interfaces across the overarching (patient to patient) E2E PV and labeling process
• Ensure focused discussion on hot topics emerged at recent forums and the latest industry benchmark data

• Regulatory insights and Reference Labeling
• Development Labeling – what does good look like?
• How to build a business case for strategic labeling

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.

We are delighted to offer a two day meeting this November, to include a unique one day session across our portfolio of PV and Regulatory networks. Our aim is to:

• Provide a rich and practical perspective on the latest technology innovations – how automation and analytics are changing our world
• Host a deep dive discussion on the cross functional interfaces across the overarching (patient to patient) E2E PV and labeling process
• Ensure focused discussion on hot topics emerged at recent forums and the latest industry benchmark data

• Regulatory insights and Reference Labeling
• Labeling for different sectors: Devices, Combination Products, Biosimilars, and Consumer Products
• Next generation competencies and resourcing

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

We are delighted to offer a two day meeting this November, to include a unique one day session across our portfolio of PV and Regulatory networks. Our aim is to:

• Provide a rich and practical perspective on the latest technology innovations – how automation and analytics are changing our world
• Host a deep dive discussion on the cross functional interfaces across the overarching (patient to patient) E2E PV and labeling process
• Ensure focused discussion on hot topics emerged at recent forums and the latest industry benchmark data

• The latest RIM context and Regulatory updates
• Implementing risk based global processes
• Systems integration

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

We are delighted to offer a two day meeting this November, to include a unique one day session across our portfolio of PV and Regulatory networks. Our aim is to:

• Provide a rich and practical perspective on the latest technology innovations – how automation and analytics are changing our world
• Host a deep dive discussion on the cross functional interfaces across the overarching (patient to patient) E2E PV and labeling process
• Ensure focused discussion on hot topics emerged at recent forums and the latest industry benchmark data

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 offer a two day meeting this November, to include a unique one day session across our portfolio of PV and Regulatory networks. Our aim is to:

• Provide a rich and practical perspective on the latest technology innovations – how automation and analytics are changing our world
• Host a deep dive discussion on the cross functional interfaces across the overarching (patient to patient) E2E PV and labeling process
• Ensure focused discussion on hot topics emerged at recent forums and the latest industry benchmark data

• Regulatory update
• Vendor management – new perspectives
• Benefit Risk management – future focus
• Leveraging data and technology

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 offer a two day meeting this November, to include a unique one day session across our portfolio of PV and Regulatory networks. Our aim is to:

• Provide a rich and practical perspective on the latest technology innovations – how automation and analytics are changing our world
• Host a deep dive discussion on the cross functional interfaces across the overarching (patient to patient) E2E PV and labeling process
• Ensure focused discussion on hot topics emerged at recent forums and the latest industry benchmark data

• The latest Regulatory insights
• PV automation
• PV workforce of the future
• Vendors, value, and how to measure success

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 6th forum, which will include:

• A roundtable discussion on recent achievements and forthcoming challenges
• A look at the latest Indian and International Regulatory context
• Vision of the PV space 3-5 years from now
• Optimising the handling of PV agreements
• EudraVigilance data

Navitas Life Sciences will be at the CPhI Worldwide conference October 9-11, 2018. CPhI is an established pharmaceutical event with experience of bringing together over 25 thousand pharmaceutical executives from throughout the world.

We welcome you to Stand No. 3A102, Hall 3, to learn about your key objectives and to demonstrate how you can leverage Navitas Life Sciences’ industry expertise to overcome your challenges and beat your competitors to market. To schedule a meeting, click here

BioForward is an international conference focused on creating and developing a practical roadmap for early stage, emerging, and developing life sciences companies to achieve sustainable business success and growth. The event is aimed at professionals who are keen to gain the knowledge, skills, connectivity, and support necessary to maximise their chances of success and efficiently navigate through the various development phases to market and beyond.

Navitas Life Sciences are delighted to be exhibiting at this event. Meet with our subject matter experts, Dr. Krishnan Rajagopalan and Neil Cummins at Stand No. 4 to discover how you can transform your Clinical Trials through our insight driven Clinical, Regulatory, and Safety solutions that are customised to address your critical challenges and help you to gain a competitive advantage.

For further information, please visit the event website here.

Meet with Navitas Life Sciences at the RAPS Regulatory Convergence conference at booth 605 to learn how you can seamlessly integrate your regulatory processes to derive greater benefits from your Regulatory Information Management investments.

For more information about the conference, click here

The SCDM 2018 annual conference will explore cutting edge solutions and best practices in the Clinical Data Management industry.

Meet with us at booth 112 to discover how you can leverage OneClinical, our eClinical and analytics platform, to better manage trials, reduce risks, and make informed decisions.

For further information, please visit the event website here

RIM has emerged as a way to provide reliable, reusable, and submittable product and regulatory information. Getting to next-generation RIM requires methodical maturity that plans implemental program improvement over 5 dimensions:

1. Process
2. Governance
3. Data
4. Technology
5. Culture

This meeting will see Oracle Health Sciences strategists and solution experts meet to explore Oracle Health Sciences Empirica product updates and discuss current pharmacovigilance hot topics. The event will look at how Artificial Intelligence will revolutionise case processing in the coming years, the latest in drug safety regulations, as well as looking at the benefits of moving to the cloud.

Navitas Life Sciences’ Marty Boom and Raj Srinivasan will be in attendance at this event.

For further information please visit the event website by clicking here

If you would like to arrange to meet with a member of our team please contact marketing@navitaslifesciences.com

Presented by Sparta Systems’ Brandon Henning and Navitas Life Sciences’ Tom Beatty, this webinar will provide an overview of the FDA Guidance for the recent IDMP regulation, and explain how pharmaceutical companies should prepare and build a solution to meet the IDMP specifications that are connected to the TrackWise system.

idmpREADY, combines Navitas Life Sciences’ data management technologies to capture, record, publish, and maintain IDMP data points, together with Sparta Systems’ TrackWise QualityConnect framework to define, track, exchange, and report IDMP core processes.

Join us to explore:

• FDA and ISO requirements for IDMP
• A solution to meet the new IDMP regulations, including IDMP Submission and eCTD
• Document Management using pharmaREADY and idmpREADY software solutions

With an estimated R&D cost of $2.5 billion for a drug to reach the market, sponsor companies face increasing pressure to complete clinical trials within time and budget. Updated regulations should accelerate adoption of technology and process / role changes that will enhance operational efficiency, quality and patient safety.

Sponsors are making key changes that include adopting a quality management and risk-based approach, improved data integrity and analysis, operating model and governance model redesign, risk based monitoring, redefined roles and responsibilities (RACI) translating to a robust set of SOP updates and outcomes.

Ensuring First Time Right submissions with regulators require the development, management and near real-time analysis of data that supports the desired trial outcomes across all phases of studies. Join us to learn how companies can achieve successful outcomes through streamlined technologies that enable proactive quality and improved outcomes.

Presenters:

Dr Krishnan Rajagopalan, Chief Growth Officer, Navitas Life Sciences

Dawne Nanda, Senior Managing Consultant, Navitas Life Sciences

To register for this webinar please click here.

Hosted by Celgene, the Sidley pvlegal Forum is an interactive meeting which will include presentations on global regulatory and litigation developments, benchmarking trends, and practical case studies on industry issues. Navitas Life Sciences’ Wilfred Gilich will be in attendance at this meeting.

For further information please visit the pvlegal website here or contact a member of the team at pvlegal@sidley.com

pvlegal is a specialized forum for in-house counsel and compliance personnel working on drug and device safety issues in the Life Sciences sector. Sidley Austin LLP serves as counsel to pvlegal. Additional support and sponsorship is provided by Navitas Life Sciences.

As internal labeling processes become more mature and better defined, and labeling operations more efficient and value-driven, companies are turning their attention towards the potential of outsourcing to maximize strategic value.

This webinar explores where there are outsourcing opportunities in the labeling process and key considerations to help ensure that favorable outcomes are achieved.

Speakers:

Dr Denis Fung, Head of Regulatory and labelnet lead, Navitas Life Sciences

Zuby Okemefuna, Senior Consultant, Navitas Life Sciences

To register for this webinar please click here.

The DIA 2018 Global Annual Meeting will bring together thousands of innovators from across the globe. The event is designed to drive insights into action by connecting key policy discussions to real-world knowledge. Sessions will include distinguished speakers and expert panellists from regulatory, industry, patient advocacy, and academia.

Navitas Life Sciences are delighted to be exhibiting at this event. Meet with us at booth 2641 to discover how you can transform your Clinical Trials through our insight driven Clinical, Regulatory, and Safety solutions that are customized to address your critical challenges. To schedule a meeting with one of our Subject Matter Experts, please click here.

For further information, please visit the event website here.

Established in 2011, labelnet is a network for labelling professionals, focused on the full lifecycle of labelling. The network provides a neutral platform for Heads of Labelling and Labelling professionals to network, share insights and experiences, benchmark performance, develop best practices across the full lifecycle of labelling, from the definition of company positions (CCDS, CCSI) to local/regional labelling (SmPC, USPI, reference labels, etc.) and, ultimately, to label implementation (artwork, packaging, and electronic media)

Our June forum agenda is themed around ‘Labelling to the next level’ and will focus on the following:

• Regulatory update:
  • GVP Module IX – updates and learnings so far
  • EudraVigilance lessons learned
• Future ready labeling
  • Next generation Medical Governance – CMO viewpoint
  • Patient focus labeling – moving forward
  • E-labeling - myth or future reality?
  • Sourcing and resource models – today and tomorrow
• Labeling scorecard now and in the future
  • Why measure? What to measure and how? Early development, operational, and strategic

Established in 2006, pvconnect is a network for Heads of Safety of mid-sized life sciences companies with general portfolios or a specific focus. The network 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.

Our June agenda is themed around ‘Smart solutions in a complex world’ and will focus on the following:

• The latest PV context
  • Regulatory update
    • RoW regulations
    • CT monitoring
    • Brexit
• Inspection Readiness in a shifting global context
• Smart solutions to everyday complexities

pvtech is the joint pvnet and pvconnect interest group for individuals responsible for enable and supporting PV technologies in their organisations. Our vision is to shape the future of technology in Pharmacovigilance by providing business and technology leaders with an open environment to share challenges, but also discuss alternative solutions and develop best practices that are aligned to the future of Pharmacovigilance.

Our June agenda is themed around Automation & modern PV analytics and will focus on the following:

• PV tools and systems
  • Automation opportunities
  • Working Group update
• New sources of data
  • Changing landscape PV analytics
  • Opportunities of RWD, EHR
• PV digital roadmap

Discussions around Regulatory Information Management (RIM) within our drug safety and labelling oriented networks; pvnet, pvconnect, and labelnet, led to the initiation of a roundtable to provide a platform to share and discuss the emerging area of RIM. Established in 2014, the roundtable has since become a full network focusing on global RIM implementation – enabling members to discuss the organisation, process and technology aspects of implementing a RIM governance framework and the challenges of achieving RIM data quality.

Our June forum agenda is themed around ‘The journey to RIM maturity’ and will focus on the following:

• Brexit impact and the level of preparedness
• E2E RIM (value for business and RIM business case)
• RIM Quality metrics and KPIs
• What is RIM data?
• RIM Technology

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

Our June agenda is themed around ‘PV strategies...explored’ and will focus on the following:

• The latest PV context
  • Regulations and EudraVigilance review
  • Benchmark insights

• PV Value – the role of automation
• New approaches to value
• Automation as an enabler
• Impact on resources/talent

• The road ahead

Established in 2011, labelnet is a network for labelling professionals, focused on the full lifecycle of labelling. The network provides a neutral platform for Heads of Labelling and Labelling professionals to network, share insights and experiences, benchmark performance, develop best practices across the full lifecycle of labelling, from the definition of company positions (CCDS, CCSI) to local/regional labelling (SmPC, USPI, reference labels, etc.) and, ultimately, to label implementation (artwork, packaging, and electronic media)

Our June forum agenda is themed around ‘Labelling to the next level’ and will focus on the following:

• Regulatory update:
  • GVP Module IX – updates and learnings so far
  • EudraVigilance lessons learned
• Future ready labeling
  • Next generation Medical Governance – CMO viewpoint
  • Patient focus labeling – moving forward
  • E-labeling - myth or future reality?
  • Sourcing and resource models – today and tomorrow
• Labeling scorecard now and in the future
  • Why measure? What to measure and how? Early development, operational, and strategic

pvtech is the joint pvnet and pvconnect interest group for individuals responsible for enable and supporting PV technologies in their organisations. Our vision is to shape the future of technology in Pharmacovigilance by providing business and technology leaders with an open environment to share challenges, but also discuss alternative solutions and develop best practices that are aligned to the future of Pharmacovigilance.

Our June agenda is themed around Automation & modern PV analytics and will focus on the following:

• PV tools and systems
  • Automation opportunities
  • Working Group update
• New sources of data
  • Changing landscape PV analytics
  • Opportunities of RWD, EHR
• PV digital roadmap

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

Our June agenda is themed around ‘PV strategies...explored’ and will focus on the following:

• The latest PV context
  • Regulations and EudraVigilance review
  • Benchmark insights

• PV Value – the role of automation
• New approaches to value
• Automation as an enabler
• Impact on resources/talent

• The road ahead

Established in 2006, pvconnect is a network for Heads of Safety of mid-sized life sciences companies with general portfolios or a specific focus. The network 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.

Our June agenda is themed around ‘Smart solutions in a complex world’ and will focus on the following:

• The latest PV context
  • Regulatory update
    • RoW regulations
    • CT monitoring
    • Brexit
• Inspection Readiness in a shifting global context
• Smart solutions to everyday complexities

Discussions around Regulatory Information Management (RIM) within our drug safety and labelling oriented networks; pvnet, pvconnect, and labelnet, led to the initiation of a roundtable to provide a platform to share and discuss the emerging area of RIM. Established in 2014, the roundtable has since become a full network focusing on global RIM implementation – enabling members to discuss the organisation, process and technology aspects of implementing a RIM governance framework and the challenges of achieving RIM data quality.

Our June forum agenda is themed around ‘The journey to RIM maturity’ and will focus on the following:

• Brexit impact and the level of preparedness
• E2E RIM (value for business and RIM business case)
• RIM Quality metrics and KPIs
• What is RIM data?

Presented by Navitas Life Sciences’ Marty Boom and Denis Fung this webinar will look at the changing expectations that Regulators, and also Business Partners, have for Regulatory Affairs organisations. The core deliverables of a Regulatory organisation are still omnipresent but, in addition, we expect global integration, lowered costs, compliance, and oversight across different jurisdictions and across different, disparate processes, systems, and organisational entities. Unless we rethink how our Regulatory organisation in all its facets need to function, we will not be able to keep delivering the high quality output that Regulators and our Business Partners are demanding. Using Labeling as an example, we will provide you with a view on how a next generation Regulatory organisation can adapt to the paradigm. Join us to explore:

• What are the key drivers for change in Regulatory?
• What are the challenges?
• How can we stay compliant, improve operational efficiency, and create value?
• Our model for success for the NextGen Regulatory Operations

Navitas Life Sciences, an integrated provider with CRO, regulatory, safety, technology and benchmark services to global life sciences industry will be speaking to Life Science professionals at the May 15 – 16 Outsourcing in Clinical Trials conference in Barcelona, Spain. Navitas Life Sciences will also host an evening reception at the conference. The conference will attract life science industry professionals from the majority of the world’s largest pharmaceutical and biotech companies.

Navitas’ subject matter experts and senior management will be on hand to speak to industry professionals about current clinical trial trends, best practices on partnership models and other key topics. For more information, visit http://www.arena-international.com/octeurope/

Navitas Life Sciences will be exhibiting at OPPI (Organisation of Pharmaceutical Producers of India) The forum will provide operational and hands on discussion on the important updates that impact work across the different functions in medical (Medical Affairs , Clinical Research, Regulatory and Pharmacovigilance) to lead to better cross functional alignment for improved favorable outcomes in day to day function.

This platform will provide access to a captive audience of medical affairs personnel of most of OPPI member companies. The platform provides influence, through face-to-face opportunities to engage in dialogue with prospective clients and decision makers.

Navitas Life Sciences are sponsoring the eRegulatory Summit. The event is focused on RIM, eCTD, IDMP and TMF.

On Wednesday 25 April between 12:25 – 12:55 Navitas’ Managing Director, Marty Boom, will be presenting a session titled: ‘Ensuring regulatory outcomes through NextGen regulatory operations’

For further information about the conference, please visit the event website at: https://lifesciences.knect365.com/eregulatory-summit/

If you would like to arrange to meet with a member of our team please contact marketing@navitaslifesciences.com

Navitas Life Sciences will be at the DIA Global Labeling Conference in Bethesda, Maryland on April 24th and 25th. The conference will attract labeling and clinical safety professionals from some of the world’s largest pharmaceutical and biotech companies.

Navitas’ subject matter experts will be on hand to speak about the challenges of the end-to-end labeling and artwork management process. This one of the most difficult business processes for any life science company to manage effectively. The process typically spans the three primary divisions of any life science company – Commercial, Research and Supply Chain. World class processes and governance do not develop organically – they require a clear strategy, rigorous process design and discipline, and effective cross divisional governance. Navitas Life Sciences is an experienced strategic partner in labeling and artwork management. We have more than a decade of experience in Enterprise Labeling Process re-engineering and have team members who have played industry leadership roles in Structured Product Labeling and related data standards. In addition, we have access to a pool of talent in our Chennai Center of Excellence as well as our Central American hub in Columbia to provide cost effective labeling coordination and proof reading expertise.

Oracle Industry Connect is a two-day conference where industry peers join together to share deep-domain expertise and best practices on the mission-critical applications that are core to their businesses. Ninety percent of the breakout session content is comprised of Oracle customers providing insights on identifying and overcoming complex industry challenges.

The invitation-only event showcases:

• A community of distinguished industry thought leaders
• Exclusive networking opportunities
• Examples of cross-industry collaboration

This webinar will be co-presented by the Quality Consortium – The Avoca Group and Navitas Life Sciences and will discuss the transformations that are being made in clinical operations in order to address the requirements of ICH E6 (R2).

Presenters

Hershell Thompson- Senior Managing Consultant, Navitas Life Sciences

Dr. Janet Fernihough – Senior Consultant, Navitas Life Sciences

Dr. Cristin MacDonald – Executive Director Client Delivery, The Avoca Group

Key Takeaways

• Gain insight into how companies are modifying their standard practices to reach ICH E6 (R2) compliance
• Learn key challenge organizations face in modifying current processes for ICH E6 (R2) compliance
• Learn positive steps organizations have taken to adapt current practices to be compliant with the regulations

To register to attend please click here

Following the successful launch of pvindia in 2016, we are delighted to be hosting our fifth event this year.

pvindia is our network for regional PV leads of life science companies with pharma, consumer, generic, or mixed portfolios within the Asia Pacific region.

Our March meeting will look at the PV Change Journey. The agenda will look at:

• Introductions and the latest PV context
  • Roundtable discussion – recent achievements and forthcoming challenges
  • A regulatory perspective, the latest from the FDA , EMA and ROW
  • Other drivers for PV change and growth
• PvPI revisited – check in and lesson learnt so far
  • Reflections on PvGI implementation – to date
  • A view from PvPI, and an industry perspective on experiences so far
• E2B (R3) – expectation vs reality and where next?
  • Temperature check on the reality of E2B(R3) and where next
  • Pushing technology to the next level – Apps, automation and beyond
• Managing PV change and growth
  • Navigating PV change in an M&A situation
  • How PV Partners and vendors are changing the PV landscape – for good and bad
• Community next steps
  • Roadmap of dates, hot topics, new tools/ways to interact as a community

Dr. Janet Fernihough, MBA from Navitas Lifesciences, will lead the panel “ICH E6 R2 Compliance, Reflecting on the Actions and Process Adjustments Taken to Achieve ICH E6 R2 Compliance”. The panel includes Siobhan Hurley from Abbvie, Bodo Lutz from Novartis, Celeste Gonzalez from Boston Scientific, and Karen Hue from Aimmune Therapeutics. The panel discussion will:

• Examine how operations were assessed to determine where adjustments needed to be made to ensure compliance
• Conceptualize action plans and align responsibilities
• Evaluate the challenges and obstacles and how they were overcome
• Discuss lessons learned and what could have been done better

The session will take place at 3pm, February 27th, at the Radisson Blu Portman Hotel in London. For more information, click here

Agenda:

• The New EV System
  • Setting the context
  • Review the key elements of EV System
• Temperature check on EV Changes
  • E2B(R3) implementation - Impact to exiting processes
  • EVDAS Changes
• Summary
  • Key challenges
  • Lessons learnt
  • Q & A, Close

Join your life sciences peers for topical conversation, learning and networking at a meeting focused on the legal aspects of pharmacovigilance.

This interactive meeting will include presentations on:

• The Impact of Brexit on Pharmacovigilance
• What’s Next: Class Action Lawsuits in the EU
• PV and the New EU Data Protection Rules
• Impact of EudraVigilance Reporting Changes on PV Agreements

What is pvlegal?

pvlegal is a membership based forum for in-house counsel and compliance personnel at pharmaceutical companies working on pharmacovigilance issues. This is supported by regular benchmarking of member performance and best practice sharing in the area or drug safety. For further information please visit: http://pvlegal.navitas.net/

Agenda:

• The New EV System
  • Setting the context
  • Review the key elements of EV System
• Temperature check on EV Changes
  • E2B(R3) implementation - Impact to exiting processes
  • EVDAS Changes
• Summary
  • Key challenges
  • Lessons learnt
  • Q & A, Close

Navitas’ experts will be on hand to speak about full service clinical offerings that deliver transformational outcomes across Phase II – IV clinical trials, non – interventional studies, and biologics & biosimilars studies at ISCR’s annual meeting on 19th & 20th January in Bangalore, India. We will also demo OneClinical, our next generation clinical trials management platform at this event. To arrange a meeting, please contact marketing@navitaslifesciences.com.

Navitas rings in 2018 with “Managing PSPs”, a webinar that explores the rise of MRP/PSPs, a key area of focus for many pharmaceutical companies, and an element of the data explosion that is sweeping across the life sciences industry. The webinar will investigate the challenges associated with PSPs as well as opening a discussion on the potential opportunities for companies, looking at areas such as:

• PV involvement in PSP design and approval


• Training vendors on PSPs
• Taking a risk-based approach to PSPs
• Technologies for managing PSPs

Agenda:

• GVP Module IX - Signal Management (Revision 1)
• A quick overview
• What's new in the latest update?
• Impact beyond borders
• What does this mean for PV and Signal Management?
• How will this affect RA, labeling, and beyond?
• Model for success: process, governance, tools 
• Summary
• Top tips for success

On 7th December, join Navitas Life Sciences’ Bioavailability and Bioequivalence experts, Dr Ayaaz Hussain Khan and Dr Raghavendra Shetty, to understand how you can ensure quality and compliance, while reducing time to market and cost. In this webinar, you will learn to leverage industry best practices and the latest technology to adhere to constantly changing regulatory requirements, improve efficiencies, and get a competitive edge.

Agenda:

• GVP Module IX - Signal Management (Revision 1)
• A quick overview
• What's new in the latest update?
• Impact beyond borders
• What does this mean for PV and Signal Management?
• How will this affect RA, labeling, and beyond?
• Model for success: process, governance, tools 
• Summary
• Top tips for success

Navitas Life Sciences will be at stand 87 at the Partnerships in Clinical Trials Europe Conference in Amsterdam on November 28th & 29th. The conference will attract over 1,000 industry professionals from over 450 companies.

Navitas’ subject matter experts will be on hand to speak about full-service offerings that deliver transformational outcomes across Phase I – IV Clinical Trials, Consulting Services (including ICH E6 compliance), Non – Interventional Studies and, and Clinical Data Management. Information on our services across Regulatory, Pharmacovigilance and Safety will also be available at the stand.

Established in 2006, pvconnect provides a neutral platform for PV leaders facing similar challenges to network, debate, compare performance and share ideas on how to tackle the latest hot issues – balancing rising workload with resource constraints, managing divergent global regulatory requirements, implementing continuous benefit risk management, leveraging big data and modernising PV in the context of the seismic technology and industry shifts.

Focussing on themes in building a borderless, networked PV ecosystem

• The latest regulatory context, discussion of implementation challenges and sharing of solutions
• Managing the impact of growth and change on PV – challenges and opportunities during M&A, co-MAH agreements, divestment, expansion into new geographies
• Maintaining oversight and alignment across a 360 degree PV organisation that includes HQ, Affiliates, Partners and Vendors
• Open agenda space for facilitated discussion with peers of topics that are top of your mind on the day

For further information or to register to attend please contact pvconnect@navitaslifesciences.com

Established in 2011, labelnet provides a neutral platform for Heads of Labelling and labelling professionals to network, share insights and experiences, benchmark performance, develop best practices across the full lifecycle of labelling, from the definition of company positions (CCDS, CCSI) to local/regional labelling (SmPC, USPI, reference labels, etc.) and, ultimately, to label implementation (artwork, packaging, and electronic media).

• Strategic labeling:
• Patient centric labeling: Speed to get information to patients including e-labeling
• Operational labeling:
• Managing interfaces: global, local, partners - struggle in aligning different cultures, people, regulations, in global companies
• Affiliate perspectives on labeling: E2E tracking and impact on affiliates workload
• Managing the back-end of the labeling process: Labeling implementation after HA approval; Serialization

For further information or to register to attend please contact labelnet@navitaslifesciences.com

pvtech is the joint pvnet and pvconnect interest group for individuals responsible for enabling and supporting PV technologies in their organisations.

Our vision is to shape the future of technology in Pharmacovigilance by providing business and technology leaders with an open environment to share challenges, but also discuss alternative solutions and develop best practices that are aligned to the future of Pharmacovigilance.

We will be looking at how to increase business value from PV technology investments, as well as delivering new insights and new methods of handling the ever increasing work load, requirements and complexities.

PV tools for today and getting fit for the future

• The latest context: EU (GDPR) update, Brexit and the QPPV, Benchmark insights
• Exploration of PV compliance monitoring tools
• PV ecosystem applications and SDB integration approaches 
• A temperature check on EudraVigilance / E2B(R3) implementations
• PV ecosystem and scanning applications around the safety database
• Clinical to safety – integrating the clinical systems with the safety database
• Update from our Automation Working Group and kick-off for Digital WG

Discussions around Regulatory Information Management (RIM) within our drug safety and labelling oriented forums, pvnet, pvconnect, and labelnet, led to the initiation of a roundtable to provide a platform to share and discuss the emerging area of RIM.

Established in 2014, the first roundtable was held in May, 2014 in New York and London with participation from 13 companies. The positive feedback from the participants, and the need for further discussion led to events being held twice a year since in both locations.

This forum is now a full network focusing on global RIM implementation to provide a platform to discuss organisation, process and technology aspects.

• Implementing a RIM Governance framework
• The challenges of achieving RIM data quality

For further information or to register to attend please contact rimnet@navitaslifesciences.com

Established in 2001, pvnet provides a neutral platform for Pharmacovigilance (PV) leaders facing similar challenges to network, debate, compare performance, and share ideas on how to tackle the latest hot issues – balancing rising workload with resource constraints, managing divergent global regulatory requirements, implementing continuous benefit risk management, leveraging big data, and modernising PV in the context of the seismic technology and industry shifts.

The Autumn agenda will focus on implementation of innovation ideas, with a focus on the role of technology and new sources of data.

Focussing on themes in PV transformation and how to engage the patient

• Update on the latest external context in regulations and the life science industry
• The agenda and next steps for PV transformation teams at the convergence of technological, regulatory and industry change
• Engaging the patient in PV as ways of communicating change and medicine becomes increasingly personalised around outcomes focussed wellbeing plans

For further information or to register to attend please contact pvnet@navitaslifesciences.com

Established in 2006, pvconnect provides a neutral platform for PV leaders facing similar challenges to network, debate, compare performance and share ideas on how to tackle the latest hot issues – balancing rising workload with resource constraints, managing divergent global regulatory requirements, implementing continuous benefit risk management, leveraging big data and modernising PV in the context of the seismic technology and industry shifts.

Focussing on themes in building a borderless, networked PV ecosystem

• The latest regulatory context, discussion of implementation challenges and sharing of solutions
• Managing the impact of growth and change on PV – challenges and opportunities during M&A, co-MAH agreements, divestment, expansion into new geographies
• Maintaining oversight and alignment across a 360 degree PV organisation that includes HQ, Affiliates, Partners and Vendors
• Open agenda space for facilitated discussion with peers of topics that are top of your mind on the day

For further information or to register to attend please contact pvconnect@navitaslifesciences.com

Established in 2011, labelnet provides a neutral platform for Heads of Labelling and labelling professionals to network, share insights and experiences, benchmark performance, develop best practices across the full lifecycle of labelling, from the definition of company positions (CCDS, CCSI) to local/regional labelling (SmPC, USPI, reference labels, etc.) and, ultimately, to label implementation (artwork, packaging, and electronic media).

• Strategic labeling:
• Patient centric labeling: Speed to get information to patients including e-labeling
• Operational labeling:
• Managing interfaces: global, local, partners - struggle in aligning different cultures, people, regulations, in global companies
• Affiliate perspectives on labeling: E2E tracking and impact on affiliates workload
• Managing the back-end of the labeling process: Labeling implementation after HA approval; Serialization

For further information or to register to attend please contact labelnet@navitaslifesciences.com

pvtech is the joint pvnet and pvconnect interest group for individuals responsible for enabling and supporting PV technologies in their organisations.

Our vision is to shape the future of technology in Pharmacovigilance by providing business and technology leaders with an open environment to share challenges, but also discuss alternative solutions and develop best practices that are aligned to the future of Pharmacovigilance.

We will be looking at how to increase business value from PV technology investments, as well as delivering new insights and new methods of handling the ever increasing work load, requirements and complexities.

PV tools for today and getting fit for the future

• The latest context: EU (GDPR) update, Brexit and the QPPV, Benchmark insights
• Exploration of PV compliance monitoring tools
• PV ecosystem applications and SDB integration approaches 
• A temperature check on EudraVigilance / E2B(R3) implementations
• PV ecosystem and scanning applications around the safety database
• Clinical to safety – integrating the clinical systems with the safety database
• Update from our Automation Working Group and kick-off for Digital WG

Established in 2001, pvnet provides a neutral platform for Pharmacovigilance (PV) leaders facing similar challenges to network, debate, compare performance, and share ideas on how to tackle the latest hot issues – balancing rising workload with resource constraints, managing divergent global regulatory requirements, implementing continuous benefit risk management, leveraging big data, and modernising PV in the context of the seismic technology and industry shifts.

The Autumn agenda will focus on implementation of innovation ideas, with a focus on the role of technology and new sources of data.

Focussing on themes in PV transformation and how to engage the patient

• Update on the latest external context in regulations and the life science industry
• The agenda and next steps for PV transformation teams at the convergence of technological, regulatory and industry change
• Engaging the patient in PV as ways of communicating change and medicine becomes increasingly personalised around outcomes focussed wellbeing plans

For further information or to register to attend please contact pvnet@navitaslifesciences.com

Discussions around Regulatory Information Management (RIM) within our drug safety and labelling oriented forums, pvnet, pvconnect, and labelnet, led to the initiation of a roundtable to provide a platform to share and discuss the emerging area of RIM.

Established in 2014, the first roundtable was held in May, 2014 in New York and London with participation from 13 companies. The positive feedback from the participants, and the need for further discussion led to events being held twice a year since in both locations.

This forum is now a full network focusing on global RIM implementation to provide a platform to discuss organisation, process and technology aspects.

• Implementing a RIM Governance framework
• The challenges of achieving RIM data quality

For further information or to register to attend please contact rimnet@navitaslifesciences.com

Navitas Life Sciences will be at stand 41N04 in Hall 4.1 in the CPhI Worldwide Conference, Frankfurt, Germany. The conference, held from October 24th to 26th, will witness the participation of over 42,000 pharmaceutical professionals from 153 countries.

Navitas’ subject matter experts will be on hand to speak about our full-service offerings that deliver transformational outcomes across Phase I – IV Clinical Trials, Consulting Services (including ICH E6 compliance), Non – Interventional Studies, BA/BE Studies, and Clinical Data Management. Information on our services across Regulatory, Pharmacovigilance and Safety will also be available at the stand.

Stand 41N04 is located in the CRO & Clinical Trials Gold Zone in in Hall 4.1. For more information or to arrange a meeting at the conference, contact us at contact@navitaslifesciences.com

Following the successful launch of pvindia in 2016, we are delighted to be hosting our fourth event this year. pvindia, is our network dedicated to bringing together PV Global/Regional Heads of PV and PV Leadership teams in the APAC region.

What topics will the forum cover?

• Latest international regulatory context: FDA, EMA, progress check on E2B(R3) and lessons learnt so far
• Future automated PV process landscape and latest view of the pvtech community benchmarks
• PvGI latest news and implementation update

Hosted by Navitas Networks this webinar is presented by Gary Aldam, Senior Consultant, Navitas Life Sciences & Richard Petherick, Client Partner and rimnet Lead, Navitas Life Sciences

Agenda:

• Understand the RIM Maturity model dimensions
• Understand how to use the maturity model to plan future investment
• Understand the need to manage stakeholders and build the business case for change

Agenda:

• Regulatory drivers
• Where does RBM fit into the overall ICH E6 changes
• Risk control and the value of Quality Tolerance Limits
• The extent and nature of monitoring
• Industry status on implementation of new regulations and next steps

We are pleased to announce the next Navitas Networks Webinar is taking place on 14th September & will be presented by Mayank Raizada from Navitas Life Sciences

Agenda:

• Regulatory impacts on the safety database
• Increasing efficiency in case processing by utilising functionalities and interfaces
• Handling market complexities
• Dilemmas for using the safety database for aggregate reporting and analytics

We are pleased to announce the next Navitas Networks Webinar is taking place on 13th September & will be presented by Denis Fung from Navitas Life Sciences.

Agenda:

• The evolving labeling organisation
• Key requirements
• Simplicity or Specialism?
• Organizing your Global Labeling Function
• Building a more effective Global Labeling function
• What is the best fit for your company?
• So what and where next?
• Key pain points
• What is the optimal structure?
• Q & A, Close

We are pleased to announce the next Navitas Networks Webinar is taking place on August 30th & will be presented by Govind Srinivasan, Jim Chesterman, Zuby Okemefuna & Midhun Kiriyan from Navitas Life Sciences.

Agenda:

• Introduction
• Overview of End-to-End (E2E) Labelling Technologies and Current Industry Challenges
• What possibilities exist for E2E Label Tracking?
• Manual, system assisted tracking
• Loosely coupled, integrated system
• Fully integrated system
• Looking towards the future
• How can Navitas help you move forward?
• Our related services
• Q&A

Presented by Andy Lawton, Consultant and Director of Risk Based Approach Ltd and Janet Fernihough, Senior Consultant at Navitas Life Sciences.

Agenda:

• What is Quality by Design?

• Regulatory perspective
• Drivers for quality in the pharmaceutical industry 

• What can we learn about Quality by design from the manufacturing industry?

• The importance of design, control and improve.
• Application at the project and trial level

• Applying Quality by Design learning in manufacturing to clinical trial management

• Risk assessments
• Quality tolerance limits
• Continuous process improvement

We are pleased to announce the next Navitas Networks Webinar is taking place on 20th July & will be presented by Martin Holms-Petersen, Senior Consultant and Head of pvtech Navitas Life Sciences.

Agenda:

• Regulatory impacts on the safety database
• Increasing efficiency in case processing by utilising functionalities and interfaces
• Handling market complexities
• Dilemmas for using the safety database for aggregate reporting and analytics
• Looking forward

Navitas presents at DIA Annual Meeting in Chicago.

Principal Consultant Jeffrey Ho will present “Successes and Challenges in Achieving and Maintaining Oversight of Pharmacovigilance Affiliates” at DIA’s annual meeting in Chicago, IL at 10:30am on June 21st.

Jeffrey is part of a panel session titled “The Brave New World: The Ongoing Globalization of Pharmacovigilance”. Additional panelists include the Global Head of Pharmacovigilance and Medical Affairs from Otsuka Pharmaceuticals.

For more information on the sessions, click here.

To arrange a meeting with Navitas pharmacovigilance experts, click here.

Established in 2006, pvconnect provides a neutral platform for PV leaders facing similar challenges to network, debate, compare performance and share ideas on how to tackle the latest hot issues – balancing rising workload with resource constraints, managing divergent global regulatory requirements, implementing continuous benefit risk management, leveraging big data and modernising PV in the context of the seismic technology and industry shifts.

Agenda topics for Spring 2017 will include the need to balance compliance with agility; our London forum will be centred on QPPV-related discussions.

For further information or to register to attend please contact pvconnect@navitaslifesciences.com

pvtech is the joint pvnet and pvconnect interest group for individuals responsible for enabling and supporting PV technologies in their organisations.

Our vision is to shape the future of technology in Pharmacovigilance by providing business and technology leaders with an open environment to share challenges, but also discuss alternative solutions and develop best practices that are aligned to the future of Pharmacovigilance.

We will be looking at how to increase business value from PV technology investments, as well as delivering new insights and new methods of handling the ever increasing work load, requirements and complexities.

For further information or to register to attend please contact pvtech@navitaslifesciences.com

pvtech is the joint pvnet and pvconnect interest group for individuals responsible for enabling and supporting PV technologies in their organisations.

Our vision is to shape the future of technology in Pharmacovigilance by providing business and technology leaders with an open environment to share challenges, but also discuss alternative solutions and develop best practices that are aligned to the future of Pharmacovigilance.

We will be looking at how to increase business value from PV technology investments, as well as delivering new insights and new methods of handling the ever increasing work load, requirements and complexities.

For further information or to register to attend please contact pvtech@navitaslifesciences.com

Discussions around Regulatory Information Management (RIM) within our drug safety and labelling oriented forums, pvnet, pvconnect, and labelnet, led to the initiation of a roundtable to provide a platform to share and discuss the emerging area of RIM.

Established in 2014, the first roundtable was held in May, 2014 in New York and London with participation from 13 companies. The positive feedback from the participants, and the need for further discussion led to events being held twice a year since in both locations.

This forum is now a full network focusing on global RIM implementation to provide a platform to discuss organisation, process and technology aspects.

For further information or to register to attend please contactrimnet@navitaslifesciences.com

Established in 2001, pvnet provides a neutral platform for Pharmacovigilance (PV) leaders facing similar challenges to network, debate, compare performance, and share ideas on how to tackle the latest hot issues – balancing rising workload with resource constraints, managing divergent global regulatory requirements, implementing continuous benefit risk management, leveraging big data, and modernising PV in the context of the seismic technology and industry shifts.

The Spring agenda will focus on implementation of innovation ideas, with a focus on the role of technology and new sources of data.

For further information or to register to attend please contact pvnet@navitaslifesciences.com

Established in 2006, pvconnect provides a neutral platform for PV leaders facing similar challenges to network, debate, compare performance and share ideas on how to tackle the latest hot issues – balancing rising workload with resource constraints, managing divergent global regulatory requirements, implementing continuous benefit risk management, leveraging big data and modernising PV in the context of the seismic technology and industry shifts.

Agenda topics for Spring 2017 will include the need to balance compliance with agility; our London forum will be centred on QPPV-related discussions.

For further information or to register to attend please contact pvconnect@navitaslifesciences.com

Established in 2011, labelnet provides a neutral platform for Heads of Labelling and labelling professionals to network, share insights and experiences, benchmark performance, develop best practices across the full lifecycle of labelling, from the definition of company positions (CCDS, CCSI) to local/regional labelling (SmPC, USPI, reference labels, etc.) and, ultimately, to label implementation (artwork, packaging, and electronic media).

The Spring agenda will focus on smart labeling and will include smart strategy (development labeling and local intelligence), smart resources (outsourcing and key labeling roles) and smart management (labeling across sectors and back end of the E2E process) and smart technology (one day technology showcase on labeling and RIM key tools and systems (in London only)

For further information or to register to attend please contact labelnet@navitaslifesciences.com

cmonet was launched in 2014 and since then twenty CMOs from a range of large and medium pharmas and biotechs have participated. Fifteen CMOs completed a survey on the evolving role of the CMO. Three face-to-face meetings have taken place with member-led agendas relating to challenges in common and the evolving context.

For more information please contact cmonet@navitaslifesciences.com

Navitas along with Sparta Systems is exhibiting at CAPA & Root Cause Investigation Workshop. CPhI’s CAPA & Root Cause Investigation Workshop is the only forum in India dedicated to identifying non-compliance, understanding the root cause, and responding with appropriate corrective and preventive actions for the Pharmaceutical companies. It is an exclusive workshop mentored by Former USFDA Director on areas of quality and manufacturing in Pharma companies with focus on USFDA’s Quality System Guide, recent Warning Letters and EU-GMP Chapter 1 regulations.

If you would like further information, please contact us at: contact@navitaslifesciences.com

Webinar will cover:

• New regulatory requirements – and their advantage
• Organizational challenges
• How to prepare – quickly – for submitting applications electronically
• Document granularity considerations
• What to do with legacy documents
• Document templates – not optional
• How to use the FDA’s Gateway and more

Discussions around Regulatory Information Management (RIM) within our drug safety and labelling oriented forums, pvnet, pvconnect, and labelnet, led to the initiation of a roundtable to provide a platform to share and discuss the emerging area of RIM.

Established in 2014, the first roundtable was held in May, 2014 in New York and London with participation from 13 companies. The positive feedback from the participants, and the need for further discussion led to events being held twice a year since in both locations.

This forum is now a full network focusing on global RIM implementation to provide a platform to discuss organisation, process and technology aspects.

For further information or to register to attend please contactrimnet@navitaslifesciences.com

Established in 2011, labelnet provides a neutral platform for Heads of Labelling and labelling professionals to network, share insights and experiences, benchmark performance, develop best practices across the full lifecycle of labelling, from the definition of company positions (CCDS, CCSI) to local/regional labelling (SmPC, USPI, reference labels, etc.) and, ultimately, to label implementation (artwork, packaging, and electronic media).

The Spring agenda will focus on smart labeling and will include smart strategy (development labeling and local intelligence), smart resources (outsourcing and key labeling roles) and smart management (labeling across sectors and back end of the E2E process) and smart technology (one day technology showcase on labeling and RIM key tools and systems (in London only)

For further information or to register to attend please contact labelnet@navitaslifesciences.com

We are pleased to announce the next Navitas Networks Webinar is taking place on 8th May & will be presented by Gary Aldam and Mayank Raizada

Agenda:

• The evolving IDMP guidelines
• Key requirements
• Expected timelines
• What it means in reality?
• 5 steps to IDMP readiness – a pyramid for success
• Data management
• Governance, Organisation
• Process and Technology
• So what and where next?
• Benefit or burden?
• Where will it lead?
• Q & A, Close

Agenda:

• Update on Risk Management in Europe
• Overview of RM in EU
• Summary of GVP V and VXI changes
• Practical application: What does it mean?
• Focus of the implementation taskforce
• Maintaining the EU norm through change
• Understanding the scientific shift in RM
• Transitioning to the revised template
• Updating the QMS
• Global impact

Navitas will be exhibiting in upcoming eRegulatory Summit in Madrid which focuses on Connecting rim, IDMP and eCTD professionals to drive regulatory strategies through authority access and industry expertise.

Garry Aldam, Senior Consultant and David Gwyn, Head of Technology Practice at Navitas Life Sciences along with Michael Kline, Senior Solutions Consultant at Sparta Systems, will be speaking on topic “Addressing IDMP Requirements with Navitas and TrackWise – the system you most likely already have.” at 15:50, Apr 25

If you would like further information, please contact us at: contact@navitaslifesciences.com

We are pleased to announce the next Navitas Networks Webinar is taking place on 24th April and will be presented by Denis Fung (Navitas), Suzette Hildebrand (Pfizer) and Ellen Wong (Allergan)

Agenda:

• The what and why of PLLR
• Why PLLR – context and story so far
• Review of Regulations 1 year on – reflections and impacts
• A Reflection of different company experiences
• Pfizer case study
• Allergan case study
• Discussion on challenges, lessons learnt and further questions to ponder
• Forward Look
• Summary of emerging Best practice
• Q&A Close