09
Dec 2015

Safety Requirements for Medical Devices and Combination Products

Date: 09 December 2015
Venue: 15:30 – 17:00 GMT



Hosted by Navitas Networks, this webcast will be presented in three sections and will address the following:

Presented by Tido Eger, Navitas

  • Safety drivers for pharmaceutical companies in the medical device space
  • The differences between drug and device requirements, including drug vs. device reporting
  • The challenges for pharmaceutical companies around Safety reporting for devices and CP
  • The view and solutions from Navitas
Presented by Maurits Lugard, Sidley Austin LLP
  • Current safety requirements – focus on vigilance reporting
  • Enforcement landscape and expectations of authorities and notified bodies
  • Medical Devices and IVD Regulations – thoughts on new safety requirements
Presented by Dan Zenker, Navitas
  • Case study: what we are seeing in industry, our approach, solution, and challenges

To register please click here

For further information please contact This email address is being protected from spambots. You need JavaScript enabled to view it.

02
Dec 2015

rimnet Forum

Date: 02 December 2015
Venue: Sidley Austin LLP offices in London
RIMnet



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 City and London. The positive feedback from the participants, and the need for further discussion led to a second roundtable being held in fall 2015, again in both locations.

Moving forward, our vision for rimnet is to provide regulatory professionals with a network to be able to share and openly discuss challenges, approaches, and best practices in respect of RIM.

If you are interested in further information or participating at this meeting, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

17
Nov 2015

IDMP Readiness Revisited Webcast

Date: 17 November 2015
Venue: 15:30 – 17:00 (GMT)



Owing to the popularity of this webcast back in October, we will be re-running the session.

Hosted by Navitas Networks, this webcast will explore IDMP Readiness and address the following:

  • Latest update on regulatory context for IDMP
  • Real-time IDMP examples – the challenges our clients are facing
  • IDMP readiness – what good looks like
  • Where next?
To register to attend this webcast, please click here or for further information please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

11
Nov 2015

rimnet Forum

Date: 11 November 2015
Venue: Sidley Austin LLP offices in New York
RIMnet



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 City and London. The positive feedback from the participants, and the need for further discussion led to a second roundtable being held in fall 2015, again in both locations.

MMoving forward, our vision for rimnet is to provide regulatory professionals with a network to be able to share and openly discuss challenges, approaches, and best practices in respect of RIM.

If you are interested in further information or participating at this meeting, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

11
Nov 2015

pvtech Forum

Date: 11 November 2015
Venue: Sidley Austin LLP offices in New York
pvtech



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 whilst increasing business value from their technology investments.

If you are interested in further information or participating at this meeting, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

11
Nov 2015

pvconnect Forum

Date: 11 November 2015
Venue: Sidley Austin LLP offices in New York
pvconnect



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.

If you are interested in further information or participating at this meeting, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

10
Nov 2015

pvnet Summit

Date: 10 November 2015
Venue: Sidley Austin LLP offices in New York
pvnet



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.

If you are interested in further information or participating at this meeting, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

05
Nov 2015
Date: 05 November 2015
Venue: 11 AM EST



Legal Contract Management – control your contracts by leveraging the power of metadata. Review a dashboard of upcoming contract renewals, determine the value of what is ahead combined with the workload and the resources needed. Witness what is possible through a next-generation user experience in an environment where simple solutions are often the most useful. Take control of your contracts instead of them controlling you.

Register Now!

05
Nov 2015

pvconnect Forum

Date: 05 November 2015
Venue: Sidley Austin LLP offices in London
pvconnect



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.

If you are interested in further information or participating at this meeting, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

05
Nov 2015

pvtech Forum

Date: 05 November 2015
Venue: Sidley Austin LLP offices in London
pvtech



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 whilst increasing business value from their technology investments.

If you are interested in further information or participating at this meeting, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

04
Nov 2015
Date: 04 November 2015
Venue: 11 AM EST



Human Resource Management – integrate the management of offer letters, personnel files and other critical HR documents in the same platform you use for the rest of your business. Provide automated review and approval processes both in the office and through mobile devices and avoid manual paper processing. Take your HR environment to the next generation while leveraging your current content management investment.

Register Now!

03
Nov 2015

pvnet Summit

Date: 03 November 2015
Venue: Sidley Austin LLP offices in London
pvnet



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.

If you are interested in further information or participating at this meeting, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

29
Oct 2015
Date: 29-30 October 2015
Venue: The Westin, Mumbai, India
cmonet



Navitas is participating along with Sparta Systems in this workshop that brings you a two-day Data Integrity, Reliability & Quality Metrics. The workshop focuses on the issues related data integrity, reliability and also on quality metrics and pilot programs in the US. Experts from Lachman Consultants will be conducting the Workshop.

29
Oct 2015
Date: 29 October 2015
Venue: 11 AM EST



Quality – manage you standard operating procedures (SOP), work instructions, specifications, analytical methods and other quality-related documents in a sip le yet powerful user interface. Manage the lifecycle of the documents from draft through effective and control where documents are printed and who can access copies and at what status. Witness the simple power of scanning a QR code to retrieve the current SOP on the shop floor with your handheld device. Experience simple, innovative and controlled quality document management.

Register Now!

24
Oct 2015
Date: 24-28 October 2015
Venue: Baltimore, Maryland
RAPS



Navitas will be highlighting regulatory operations outsourcing solutions, along with eCTD software, at the Regulatory Affairs Professional Society (RAPS) annual meeting. The solutions highlighted will include Submissions & Report Publishing, License Maintenance, Labeling & Artwork Services, Regulatory Information Management and Regulatory Strategy & Support. Additionally, pharmaReady®, Navitas’ suite of fully integrated regulatory document management system, from document creation through regulatory submissions, will be demonstrated.

27
Oct 2015
Date: 27 October 2015
Venue: 11 AM EST



Correspondence Management – track communications more effectively by collating all information together in a single entity in your repository. Witness the integration of emails with attachments from a regulatory authority being stored as combined PDF document, complete with a forms-based manifestation of all critical metadata about the correspondence. Reduce your stress level when tracking and responding to health authorities with the next-generation user experience.

Register Now!

22
Oct 2015
Date: 22 October 2015
Venue: 11 AM EST



Mobile Access – experience content management 21st century where key decision makers can review and approve documents securely from their mobile devices. Watch a live demonstration showing interaction between a user on their computers and a user on their mobile phone. See how efficient it can be to work remotely using a custom-built application instead of a mobile browser, logging in with a scan of a thumbprint and signing a document without putting a pen to paper.

Register Now!

21
Oct 2015
Date: 21 October 2015
Venue: 15:30 – 17:00 (British Summer Time)



Hosted by Navitas Networks, this webcast will explore IDMP Readiness and address the following:

  • Latest update on regulatory context for IDMP
  • Real-time IDMP examples – the challenges our clients are facing
  • IDMP readiness – what good looks like
  • Where next?
To register to attend this webcast, please click here or for further information please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

Most Marketing Authorisation Holders, as well as Contract Manufacturing Organisations, are starting to prepare for IDMP. A global compliance requirement that will become legally enforceable by the EMA from the middle of 2016 onwards.

During the summer period, the EMA IDMP Taskforce has given an insight to the approach they are proposing to the European Commission to follow. Although timelines are more realistic, the amount of effort involved, associated budgets required, and resources to plan for over the years to come, are still very substantial.

There is no doubt, from an objective perspective, that what IDMP proposes makes good sense. However, what we have seen so far within our client engagements, is that the transition to IDMP raises a lot of challenges, both technological as well as organisational.

There are many elements to IDMP that organisations need to consider, compliance to the EMA, although important, is just one of them. In order for global organisations to ensure that a truly long-term sustainable solution is in place they must think of IDMP holistically.

Click here to view our latest thoughts on IDMP.

20
Oct 2015
Date: 20 October 2015
Venue: 11 AM EST



Electronic Trial Master File (eTMF) – learn how to manage your TMF electronically, reducing your dependence on paper files while maintaining a compliant repository. See how you can scale this platform by selectively opening access to external partners and providing a user experience that Principal Investigators and Clinical Research Assistants can use without training. Experience an integrated solution that connects with your regulatory submission platform to enable sharing of documents and eliminating duplicates and mistakes.

Register Now!

14
Oct 2015
Date: 14-16 October 2015
Venue: Renaissance Arlington Capital View Hotel, Arlington, Va.
cmonet



Navitas is proud sponsor at this prestigious conference that provides details on the key requirements for implementation of the DSCSA, with a legislative and regulatory review and insights into state requirements and pre-emption.

09
Oct 2015
Date: 09-10 October 2015
Venue: Hotel Sofitel, Bandra East, Mumbai, India
cmonet



The 18th Indian Drug Manufacturers APA Pharmaceutical Analysts’ Convention is themed around ‘Quality and Compliance – Global Expectations’. The convention will look at global requirements in the field of Quality Management and Regulatory Compliance and address the issues and challenges facing the industry.

On Friday 09 October, Navitas CEO, Jim Tizzard will address delegates with a session titled ‘Quality and Compliance, Reputation and Leadership’. In addition, Navitas’ Head of Operations, Marty Boom, will present a session titled ‘‘Integrating to the global QMS – best practices’

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

08
Oct 2015
Date: 08 - 10 October 2015
Venue: Country Inn & Suites By Carlson, Mysore, Karnataka India
cmonet



Navitas is proud sponsor at this prestigious conference that encourages statistical programmers from the healthcare industry to convene, and provides a platform to share novel ideas in statistical programming, network and strengthen statistical programming community in India.

06
Oct 2015
Date: 06 October 2015
Venue: Copenhagen Park Inn by Radisson, Copenhagen Airport Hotel, Denmark
nordic pharmacovigilance day



Navitas’ Principal Consultant, Jeffrey Ho, and Senior Consultant, Martin Holm-Petersen, will both be speaking at the Nordic Pharmacovigilance Day 2015.

Martin Holm-Petersen is a member of the Scientific Board and will co-chair the event with Anne Gramkow, Head of Drug Safety and QPPV at Pharmacosmos. The event will share best practices, results, and experiences within the field of Pharmacovigilance.

Navitas’ Jeffrey Ho will present a session on Affiliate PV Risk.

Further information can be found on the event website here.

26
Aug 2015

TAKE Academy of Life Sciences and Leadership One day Workshop: Regulatory Compliance with Current Challenges

Date: 26 August 2015
Venue: 09:00 – 17:30, Taj Krishna, Hyderabad, India



Navitas’ Principal Consultant, Oliver Steck will be speaking at this one day workshop focusing on Regulatory Compliance with Current Challenges

The workshop will address:

  • Challenges relating to PDUFA fees
  • Process development
  • Technology transfer
  • Exhibit batches
  • Data generation
  • Stability data

This workshop will provide valuable insights through case studies and methodologies, to all sterile and non-sterile pharma and biotechnology industries. The program is aimed at:

  • CEOs
  • Directors
  • VPs
  • GMs
  • Senior Managers

Further information and details of how to register can be found on the event website here

25
Aug 2015

TAKE Academy of Life Sciences and Leadership One day Workshop: Regulatory Compliance with Current Challenges

Date: 25 August 2015
Venue: 09:00 – 17:30, Taj West End, Bangalore, India



Navitas’ Principal Consultant, Oliver Steck will be speaking at this one day workshop focusing on Regulatory Compliance with Current Challenges

The workshop will address:

  • Challenges relating to PDUFA fees
  • Process development
  • Technology transfer
  • Exhibit batches
  • Data generation
  • Stability data

This workshop will provide valuable insights through case studies and methodologies, to all sterile and non-sterile pharma and biotechnology industries. The program is aimed at:

  • CEOs
  • Directors
  • VPs
  • GMs
  • Senior Managers

Further information and details of how to register can be found on the event website here

19
Aug 2015

Webinar: EDM Submission Reference Model - Shaping how submission content is managed

Date: 19 August 2015
Venue: 10:00–11:00 Eastern Time



Navitas’ content management practice lead, David Gwyn, will be speaking on the EDM Reference Model. IRISS is recognized as a pharmaceutical industry trade organization, which provides a mechanism for IRISS (Implementation of Regulatory Submission Standards) to collaborate with other trade organizations within the pharmaceutical industry (i.e. PhRMA, DIA, RAPS, HL7) as well as global health authorities.

Mr. Gwyn’s presentation “EDM Submission Reference Model - Shaping how Submission Content is Managed” will showcase the output of DIA’s (Drug Information Association) EDM Submission Reference Model team and present the background of how the model was created, where it is today and the future roadmap of development. The session will conclude with information on how to obtain the model and how to participate in future activities. The topic and content are the output of DIA’s (Drug Information Association) EDM Submission Reference Model team that Mr. Gwyn led.

Register Now!

27
Jul 2015

5th Annual Medical Device Global Regulatory Intelligence Conference

Date: 27 - 28 July 2015
Venue: Alexandria, Virginia
pvnet



Mayank Raizada will be presenting ‘Regulatory Aspects and Practical Considerations for Combination Product Surveillance’. Mayank’s session will explore the impact of regulations for managing Combination Products on safety surveillance and product quality while providing an understanding on how the variability in combination product regulations is forcing companies to re-evaluate the functioning to ensure compliance and maintain efficiency.

The talk will also provide attendees the building blocks for setting up a compliant and efficient process for managing combination product surveillance, highlighting how governance can be the glue that binds Process, Organization, and Compliance together where functional ownership fails.

01
Jul 2015

End-to-End Labelling webinar

Date: 01 July, 2015

Time: 16:30 – 18:00 Central European Time
15:30 – 17:00 British Summer Time
10:30 – 12:00 Eastern Daylight Time
Navitas are excited to announce the third webinar in our series, focusing on the topic of End-to-End (E2E) Labelling.

Label management is a complex activity that is on-going throughout the lifecycle of a pharmaceutical product. Effective labelling, from label creation and updates through to implementation, is a truly cross-functional process which spans across Pharmacovigilance, Regulatory Affairs, Medical Affairs, and Supply Chain. The need to have E2E labelling oversight is now a regulatory expectation and no longer just a future requirements. E2E tracking of status and timelines is an essential part of enabling E2E labelling oversight, i.e. from confirmation of safety signal to label implementation ‘in pack’.

Presented by Denis Fung, Senior Managing Consultant at Navitas, this webinar will look to address the following:
  • End-to-end labelling – why is it important?
  • Patient Safety
  • PV Compliance
  • A new paradigm of E2E labelling – from signal to patient
  • What does good look like? Process, Governance, and Technology
  • One goal, one voice: the cross-functional paradigm (PV, RA, Supply Chain, Medical Affairs, etc.)
  • Looking forward
The webinar is aimed at professionals within Regulatory Affairs, Drug Safety and Pharmacovigilance, Clinical Development, QA, Artwork, Supply Chain, and others who would like to discover how to improve compliance and develop best practices in relation to E2E labelling.

If you would like further information, or you would like to register to attend this webinar, please contact us at: This email address is being protected from spambots. You need JavaScript enabled to view it.

08
June 2015

Sparta Connection 2015

Date: 08-11 June 2015
Venue: Swan and Dolphin Resort in Orlando, FL, USA
Sparta Connection 2015



Navitas is the Gold Sponsor of Sparta Connection. Navitas’ Dave Gwyn will talk about the critical issues Life Science companies face with their TrackWise implementation, upgrades, data migration, reporting, integrations, support and the advantages of cloud hosting.

Also presenting at the conference are representatives from Roche, Johnson & Johnson, GE Healthcare, Otsuka, Janssen, Stryker, BD, Eli Lilly, Perrigo, Genentech and more.

10
Jun 2015

pvnet Summit

Date: 10 June 2015
Venue: Sidley Austin LLP offices in London
pvtech



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.

If you are interested in further information or participating at this meeting, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

09
Jun 2015

pvconnect Forum

Date: 09 June 2015
Venue: Sidley Austin LLP offices in London
pvconnect



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.

If you are interested in further information or participating at this meeting, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

09
Jun 2015

pvtech Forum

Date: 09 June 2015
Venue: Sidley Austin LLP offices in London
pvtech



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 whilst increasing business value from their technology investments.

If you are interested in further information or participating at this meeting, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

04
Jun 2015

labelnet Forum

Date: 04 June 2015
Venue: Sidley Austin LLP offices in New York
labelnet



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).

If you are interested in further information or participating at this meeting, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

04
Jun 2015

pvtech Forum

Date: 04 June 2015
Venue: Sidley Austin LLP offices in New York
PVtech



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 whilst increasing business value from their technology investments.

If you are interested in further information or participating at this meeting, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

04
Jun 2015

pvconnect Forum

Date: 04 June 2015
Venue: Sidley Austin LLP offices in New York
pvconnect



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.

If you are interested in further information or participating at this meeting, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

03
Jun 2015

rimnet Forum

Date: 03 June 2015
Venue: Sidley Austin LLP offices in New York
RIMnet



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 City and London. The positive feedback from the participants, and the need for further discussion led to a second roundtable being held in fall 2015, again in both locations.
Moving forward, our vision for rimnet is to provide regulatory professionals with a network to be able to share and openly discuss challenges, approaches, and best practices in respect of RIM.

If you are interested in further information or participating at this meeting, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

02
Jun 2015

pvnet Summit

Date: 02 – 03 June 2015
Venue: Sidley Austin LLP offices in New York
pvnet



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.

If you are interested in further information or participating at this meeting, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

21
May 2015

rimnet Forum

Date: 21 May 2015
Venue: Sidley Austin LLP offices in London
RIMnet



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 City and London. The positive feedback from the participants, and the need for further discussion led to a second roundtable being held in fall 2014, again in both locations.

Moving forward, our vision for rimnet is to provide regulatory professionals with a network to be able to share and openly discuss challenges, approaches, and best practices in respect of RIM.

If you are interested in further information or participating at this meeting, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

19
May 2015

labelnet Forum

Date: 19 – 20 May 2015
Venue: Sidley Austin LLP offices in London
Labelnet



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).

If you are interested in further information or participating at this meeting, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

17
May 2015

Pharma SUG Annual Conference

Date: 17-20 May 2015
Venue: Ornaldo, FL, US
Pharma SUG Annual Conference



Navitas will present “Accelerate define.xml generation using Define Ready” at the Pharma SUG Annual Conference in Orlando, May 18th at 9:30a.m. in the Oceans Ballroom 3 at the Renaissance Orlando at Seaworld. The presentation looks at the FDA & other regulatory agencies mandate of electronic submissions and standardized data, along with CDISC SDTM and ADaM based standards. An important component of such submissions is the generation of the CRT-Data Definition Document (Define xml).

12
May 2015

Benefit:Risk Management (BRM) webinar

Date: 12 May, 2015

Time: 16:30 – 18:00 Central European Time
15:30 – 17:00 British Summer Time
10:30 – 12:00 Eastern Daylight Time

Navitas are excited to announce the second webinar of our series, focusing on the topic of Benefit:Risk Management (BRM).

Health Authorities around the world require that Life Sciences companies perform comprehensive evaluations of their products’ Benefit:Risk relationships throughout their lifecycles, based on information sourced from numerous stakeholders who have not traditionally been intimately engaged in pharmacovigilance activities. In response, companies are establishing and refining processes, tools, and governance structures to ensure that all relevant efficacy and safety information is considered, and that related decisions are implemented and effective. Increasingly sophisticated methods to gather and analyse safety and benefit information are being employed, responding to the challenges associated with doing so, addressing the implications of the results, and monitoring the effectiveness of their responses to these analyses.

The environment continues to evolve, however, as both patients and payers follow and analyse Benefit:Risk information more closely and, in fact, base selection and reimbursement decisions on this information. As a result, companies must respond to current requirements regarding Benefit:Risk analysis while closely monitoring and responding to the expectations of regulators, payers, and patients as these requirements mature. The ability to meets these expectations will directly impact a product’s success in the market, so the stakes are high.

Presented by Sharmila Sabaratnam, Managing Consultant at Navitas, this webinar will look to address the following:
  • The BRM bar has been raised – a look at the drivers and the context
  • Industry status today
  • A model for success
  • BRM framework
  • Collaboration in action
  • Capability requirements
  • Tracking solutions
  • A look to the future
Aimed at Drug Safety, Clinical Research, Regulatory Affairs, GxP QA, and Market Access Professionals.

For further information, or if you would like to register to attend this webinar, please contact us at: This email address is being protected from spambots. You need JavaScript enabled to view it.

11
May 2015

DIA’s eRegulatory and Intelligence Annual Conference

Date: 11-13 May 2015
Venue: Sheraton Philadelphia Downtown Hotel, Philadelphia, PA 19103
DIA eRegulatory and Intelligence Annual Conference



Navitas will be at booth 110 at the DIA eRegulatory and Intelligence Annual Conference, May 11th – 13th in Philadelphia, PA. Regulatory Information Management (RIM) is a key topic in the Life Science Industry and Navitas will highlight how content management is the key component to RIM. RIM looks at regulatory issues as an end-to-end process, and content management is the cornerstone of all regulatory activities.

4
May 2015

CDISC Europe Interchange

Date: 4–8 May, 2015
Venue: Congress Center Basel, Basel, Switzerland
CDISC Europe Interchange



Navitas is pleased to sponsor the CDISC Europe Interchange in Basel, Switzerland May 4th – 8th. Georgina Wood, Navitas’ Clinical Data Services practice lead, will speak about exciting new opportunities in the clinical data space concerning data warehousing with Oracle’s LSH/DMW as well as data visualization and statistical computing. Ms. Wood was formerly Global Head of Technology Innovations at Novartis.

4
May 2015

EMC World

Date: 4–7 May, 2015
Venue: The Venetian. Las Vegas, NV, USA
EMC World



Navitas will be presenting Regulatory Information Management (RIM) for the Life Sciences industry at EMC World Las Vegas, May 4th – 7. Life Science companies are IP driven and Navitas will demonstrate how technology, the Next Generation User Interface and process are the keys to Regulatory excellence.

16
Apr 2015

Live Webinar - SMB Compliance Solution for May 2015 Deadline - US Federal Drug Supply Chain Security Act

Date: 16 April, 2015
Time: 3 PM IST



Join Axway’s leading expert, Peter Stokes and Navitas’ Associate Vice President, B Sivanandam on this timely webinar as you prepare to comply with DSCSA requirements for lot level traceability by May 1st, 2015.

View On-Demand Webinar

14
Apr 2015

Women’s Life Sciences Network

Date: 14 April, 2015
Time: 18:00 – 20:45
Venue: Hyatt Regency Paris Etoile, Paris, France
oracle industry connect



Navitas Principal Consultant, Louise Jebson, will be attending the Sidley event ‘Women’s Life Sciences Network’. The event will feature a panel discussion with:

Lidia Retkowska-Mika, Co-chair, DIA EuroMeeting 2015 and Director of Legal Department, Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL)
Paula Salmikangas, Chair of Committee for Advanced Therapies (CAT), European Medicines Agency (EMA) & Senior Researcher, Finnish Medicines Agency (FIMEA)
Isabelle Clamou, Director, Global Regulatory and R&D policy – Europe, Amgen

If you would like more information or have any questions please contact Cristina Menendez Ruiz at This email address is being protected from spambots. You need JavaScript enabled to view it.

13
Apr 2015

27th Annual DIA Euromeeting 2015

Date: 13-15 April, 2015
Venue: Palais des Congrès, Paris, France
oracle industry connect



Navitas Principal Consultant, Louise Jebson, will be attending the 27th Annual DIA Euromeeting as a delegate. The event this year is titled ‘Advancing Innovation to Combat the Global Burden of Disease: A Call to Action’. The meeting will address 12 themes across 5 core competencies: Clinical Development, Pharmacovigilance, Regulatory, Health Economics, and Quality and Safety

If you would like to arrange to meet with Louise, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

13
Apr 2015

IDMP webinar

Date: 13 April, 2015

Time: 16:30 – 18:00 Central European Time
10:30 – 12:00 Eastern Daylight Time
15:30 – 17:00 British Summer Time
07:30 – 09:00 Pacific Daylight Time
20:00 – 21:30 India Standard Time
Navitas are excited to announce the first webinar in our series, focusing on the topic of IDMP.

As most, if not all, pharmaceutical companies are aware, from July 2016 internally agreed terminology for the classification, retrieval, presentation, risk benefit evaluation, and assessment of pharmacovigilance and medicinal product information will become legally enforceable. These requirements apply to member states, Marketing Authorisation Holders (MAHs), and the Agency (EMA). The vehicle of choice is a set of five ISO standards, generally referred to as the Identification of Medicinal Products, or IDMP.

There is no doubt, from an objective perspective, that what IDMP proposes makes good sense. However, it does raise challenges for implementation, especially so within an industry that is under commercial pressure to cut annual budgets and reduce headcount. There are many different ways to ensure compliance with regulatory requirements, but there are only a few ways that ensure a long-term sustainable solution is in place; any solution to IDMP must be thought of holistically.

Presented by Rens van den Boomen, Senior Consultant at Navitas, this webinar will look to address the following:
  • Regulatory drivers for IDMP
  • What it means in reality
  • IDMP Readiness – how well do you know your products?
  • Roadmap to success – how to prepare and get return on your investments?
  • Where next?
Whether you are Head of Regulatory Affairs, a QPPV, managing a labelling department or are currently involved in XEVMPD submissions; IDMP will become an important aspect of your working life very soon. If you would like further information, or you would like to register to attend this webinar, please contact us at: This email address is being protected from spambots. You need JavaScript enabled to view it.

31
Mar 2015

4th Annual Clinical Data Integration and Management

Date: 31 March – 1 April, 2015
Venue: Princeton, NJ
Annual Clinical Data Integration and Management



Clinical Data Analysts from Navitas will present “Using Data Standards to Improve Efficiency in the Set – Up of Clinical Trials” at 10a.m. on March 31st. The Significance & efficiencies of CDASH in terms of traceability & consistency of d&& collaboration functionalities, and more will be covered

26
Mar 2015

Oracle Industry Connect 2015

Date: 26 March, 2015
Venue: Washington Hilton, Washington DC, USA
oracle industry connect



Navitas CEO, Jim Tizzard, will be attending this Oracle event as well as being part of a panel examining how digitising data is transforming clinical trials and exploring its impact on the future of clinical development. The session, titled ‘Digital Trials and Research Models of the Future’ will be chaired by Mukhtar Ahmed, Global Vice President Life Sciences Strategy, at Oracle.

Oracle Industry Connect is a two day conference where industry peers share deep domain expertise, insights, and best practices about the mission critical applications core to their business. This event is exclusive and invitation only.

If you would like to arrange to meet with Jim, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

16
Mar 2015

India - TrackWise User Group (TUG)

Date: 16 March, 2015
Venue: Hyatt Regency, Mumbai

Navitas and Sparta Systems will host the first TrackWise User Group (TUG) event on 16th March 2015 at the Hyatt Regency, Mumbai. This event will serve as a platform for TrackWise users from this region to connect and share their experiences and TrackWise EQMS best practices with each other. Users can also learn from experts on how to get more from their investments in TrackWise.

14
Mar 2015

PhUSE - Pharmaceutical Users Software Exchange - Mumbai

Date: 14 March, 2015
Venue: TTC Industrial Area, MIDC Navi Mumbai, India
SAP



Navitas is participating, sponsoring and presenting a session on eSubmissions – an overview in PhUSE Single Day Event. PhUSE is an independent, not-for-profit organization run by volunteers. Since its inception, PhUSE has expanded from its roots as a conference for European Statistical Programmers, to a global platform for the discussion of topics encompassing the work of Data Managers, Biostatisticians, Statistical Programmers and eClinical IT professionals.

11
Mar 2015

SAP TechEd Bangalore

Date: 11 - 13 March, 2015
Venue: Bangalore International Exhibition Centre
SAP



Navitas is one of the sponsor at this prestigious event. We will be showcasing our SAP certified mobility framework for Pre-Manufacturing, Plant Maintenance and Warehouse Edge System. SAP TechEd is the premier technical education conference for IT architects, administrators, and developers – offering more than 500 hours of training on SAP technology for in-memory computing, enterprise mobility, analytics, database, and the cloud.

26
Feb 2015

The Economist Pharma Summit

Date: 26 February, 2015
Venue: Radisson Blu Portman Hotel, London, UK

Navitas Director, Mike Giffin, will be attending The Economist Pharma Summit as a delegate.

The event, now in its 21st year, will focus on the challenges impacting the world of pharma, as well as the innovation required to face them. The Pharma Summit will address areas such as improving access and affordability of medicines, the immense differences between developed and emerging markets, technology in pharma, and enhancing partnerships across the ecosystem to benefit all.

If you would like to arrange to meet with Mike, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

24
Feb 2015

Virtue Insight 8th Pharmacovigilance 2015

Date: 24 – 25 February 2015
Venue: Marriott Marble Arch Hotel, London, UK
virtue insight Pharmacovigilance



Navitas Managing Consultant, Sharmila Sabaratnam, will be attending Virtue Insight’s 8th Pharmacovigilance conference as a delegate.

The conference will bring together top pharmaceutical, biotechnology, and regulatory representatives to address key industry issues. The program will cover the detection, analysis, and prevention of adverse drug reactions with the aid of case studies and industry experiences.

If you would like to arrange to meet with Sharmila, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

28
Jan 2015

NJ CDISC Users Group Meeting

Date: 28 January, 2015
Venue: Navitas Inc., Princeton, NJ, United States
virtue insight Pharmacovigilance




Navitas hosted this event at our US site. The attendes appreciated the quality of content presented during the event. The event focused towards Metadata management and ADaM analysis based discussions. The meeting was also organized via web-conferencing for remote access.

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