30
Nov 2016

Webinar Hosted by Navitas Networks: Medical Devices and Combination Products - Safety and Vigilance Requirements in the US and Europe

Date: 30 November, 2016
Time: 15:30-17:00 GMT



Hosted by Navitas Networks this webinar Medical Devices and Combination Products -Safety and Vigilance Requirements in the US and Europe will be presented by Navitas’ Managing Consultant Tido Eger.

Agenda:

  • Introduction 
  • The need for device vigilance in pharma companies
  • FDA’s oversight of combination products, new developments and safety concerns
  • Practical experience with FDA Combination Product rules
  • Questions & Answers 

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.

17
Nov 2016

rimnet Forum

Date: 17 November 2016
Venue: 09:30 – 16:30, 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 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.

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 a member of our rimnet team at This email address is being protected from spambots. You need JavaScript enabled to view it.

17
Nov 2016

pvconnect Forum

Date: 17 November 2016
Venue: 09:30 – 16:30, New York
labelnet



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.

For further information or to register your interest in participating at this meeting, please contact a member of our pvconnect team at This email address is being protected from spambots. You need JavaScript enabled to view it.

16
Nov 2016

labelnet Forum

Date: 16 November 2016
Venue: 09:30 – 16:3, 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 to register your interest in participating, please contact a member of our labelnet team at This email address is being protected from spambots. You need JavaScript enabled to view it.

16
Nov 2016

pvtech Forum

Date: 16 November 2016
Venue: 09:30 – 16:30, 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 a member of our pvtech team at This email address is being protected from spambots. You need JavaScript enabled to view it.

15
Nov 2016

Author-It Annual Summit for Life Sciences

Date: 15-16 November 2016
Venue: Hilton Penn’s Landing, 201 S. Columbus Boulevard, Philadelphia, PA, USA
Author-It Annual Summit for Life Sciences



Navitas’ Head of Technology, David Gwyn, will be presenting a session at this conference titled ‘Leveraging Structured Content to Streamline End-to-End Labelling’. This session, taking place on Tuesday 15 November, will discuss a new era of utilising a centralised structured content repository for managing from the CCDS to regional labelling, the integration possible to ‘manage to clock’ necessary in end-to-end tracking, and the interaction with unstructured content

For further information please visit the event website here or to arrange to meet with David please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

15
Nov 2016

pvnet Summit

Date: 15 November 2016
Venue: 09:30 – 16:30, New York
labelnet



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.

For further information or to register your interest in participating at this meeting, please contact a member of our pvnet team at This email address is being protected from spambots. You need JavaScript enabled to view it.

10
Nov 2016

pvnet Summit

Date: 10 November 2016
Venue: 09:30 – 16:30, Sidley Austin LLP Offices, London
labelnet



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.

For further information or to register your interest in participating at this meeting, please contact a member of our pvnet team at This email address is being protected from spambots. You need JavaScript enabled to view it.

09
Nov 2016

HDA’s (Healthcare Distribution Association) 2016 Traceability Seminar

Date: 09 - 11 November 2016
Venue: Renaissance Washington, DC Downtown Hotel, Washington, DC, USA
Healthcare Distribution Association



Navitas will be demonstrating traceREADY in booth 512 at PackExpo/PharmaExpo November 6-9 in Chicago, IL. traceREADY is Navitas’ Edge solution that enables DSCSA compliance. The DSCSA deadline is November 17th, 2017. traceREADY gets up and running quickly and has the lowest total cost of ownership in the marketplace. traceREADY is for Life Science companies that have to comply with DSCSA regulations including pharma/biotech manufacturers, third party logistics (3PL’s) companies and Pre-Manufacturing facilities.

For further information please visit the event website here or to schedule a demo please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

09
Nov 2016

pvtech Forum

Date: 09 November 2016
Venue: 09:30 – 16:30, Sidley Austin LLP Offices, London
labelnet



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.

For further information or to register your interest in participating at this meeting, please contact a member of our pvtech team at This email address is being protected from spambots. You need JavaScript enabled to view it.

09
Nov 2016

labelnet Forum

Date: 09 November 2016
Venue: 09:30 – 16:30, Sidley Austin LLP Offices, 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 to register your interest in participating, please contact a member of our labelnet team at This email address is being protected from spambots. You need JavaScript enabled to view it.

08
Nov 2016

rimnet Forum

Date: 08 November 2016
Venue: 09:30 – 16:30, Sidley Austin LLP Offices, London
labelnet



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.

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 a member of our rimnet team at This email address is being protected from spambots. You need JavaScript enabled to view it.

08
Nov 2016

pvconnect Forum

Date: 08 November 2016
Venue: 09:30 – 16:30, Sidley Austin LLP Offices, London
labelnet



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.

For further information or to register your interest in participating at this meeting, please contact a member of our pvconnect team at This email address is being protected from spambots. You need JavaScript enabled to view it.

06
Nov 2016

PackExpo/PharmaExpo

Date: 06 - 09 November 2016
Venue: McCormick Center, Chicago, IL, USA
PackExpo/PharmaExpo



Navitas will be demonstrating traceREADY in booth 512 at PackExpo/PharmaExpo November 6-9 in Chicago, IL. traceREADY is Navitas’ Edge solution that enables DSCSA compliance. The DSCSA deadline is November 17th, 2017. traceREADY gets up and running quickly and has the lowest total cost of ownership in the marketplace. traceREADY is for Life Science companies that have to comply with DSCSA regulations including pharma/biotech manufacturers, third party logistics (3PL’s) companies and Pre-Manufacturing facilities.

For further information please visit the event website here or to schedule a demo please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

25
Oct 2016

pvindia Forum

Date: 25 October, 2016
Venue: 09:30 – 16:00, The Hyatt Regency Hotel, Mumbai Sahar Airport, Ashok Nagar, Mumbai, Maharashtra 400099, India
pvindia



Following the successful launch of pvindia in March this year, with participation from: Alkem Laboratories, Amgen, Bayer, Boehringer Ingelheim, Colgate Palmolive, Hetero Drugs, Ipca Laboratories, Macleods Pharma, Merck and Co, Mylan, Novo Nordisk, Pfizer, and Wockhardt, we are delighted to be hosting our second event. The agenda will continue to build on the theme of PV Inspection Readiness and will include:

  • The latest PV Regulatory Context – spotlight on the evolving landscape in India
  • The global PV system – balancing global and local requirements
  • The pvindia community moving forward
pvindia leverages the approach, format and experience gained from successfully running pvnetworks over the past 15 years in Europe and the USA. This is a unique opportunity to be part of the industry leading global network for pharmacovigilance professionals

pvindia will provide 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.

For further information please click here
To register your interest in participating, please click here. If you have any further questions then please contact a member of our pvindia team at This email address is being protected from spambots. You need JavaScript enabled to view it.

25
Oct 2016

Nordic Pharmacovigilance Day 2016

Date: 25 October 2016
Venue: Park Inn by Radisson, Copenhagen Airport Hotel, Copenhagen, Denmark
Nordic Pharmacovigilance Day 2016



Navitas’ Head of pvtech and Senior Consultant, Martin Holm-Petersen, is a member of the Scientific Board and will be co-chairing this event.

Navitas’ Managing Consultant, Tido Eger, will be presenting on ‘Integrating medical devices into pharma PV and RA departments’.

For further information please visit the event website at: http://nordicpharmacovigilanceday2016.eventify.it/

19
Oct 2016

Sidley ctlegal Biannual Meeting

Date: 19-20 October 2016
Venue: Helsinn, Lugano, Switzerland
Sidley ctlegal Biannual Meeting



This event will see life sciences peers engaging in topical conversation, learning and networking. This interactive meeting will include hot topics in clinical trials (EU and USA), benchmarking trends, and practical case studies, and industry issues.

Navitas’ Senior Consultant, Janet Fernihough, will be presenting at this meeting on the topic of; ‘Risk Based Monitoring, Personalised Medicine, and Patient Engagement’

Hosted by Sidley Austin LLP, ctlegal is a membership based network for in-house counsel and compliance personnel at pharmaceutical companies working on clinical trial issues in the Life Sciences sector. The network includes regular forums supported by the benchmarking of member performance and best practice sharing in the area of clinical trials.

For further information please visit the network website at: http://ctlegal.navitas.net/ or contact This email address is being protected from spambots. You need JavaScript enabled to view it.

17
Oct 2016

Navitas Networks IDMP – Getting Ready webinar

Date: 17 October, 2016
Time: 15:30 – 17:00 British Summer Time
Navitas Networks IDMP - Getting Ready webinar



Hosted by Navitas Networks this webinar will be presented by Navitas’ Senior Consultant Gary Aldam.

The webinar will address the following:

  • The evolving IDMP regulatory landscape
  • How does industry prepare?
  • A working group perspective
  • A range of approaches
  • Getting Ready for IDMP
  • Roadmap for success, with real industry examples
  • Success strategies and lessons learnt
  • Looking forward
  • Ready or not, how success will be measured
  • Close and next steps

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.

05
Oct 2016

DIA 10th European Forum for Qualified Person for Pharmacovigilance (QPPV)

Date: 05-06 October 2016
Venue: The Crystal, London, UK
DIA 10th European Forum for Qualified Person for Pharmacovigilance (QPPV)



Now in its tenth year, the DIA European Forum for QPPV will look to meet the following objectives:

  • Hear the latest updates and hot topics relating to the role of the QPPV
  • Explore long term PV visions, future directions of the ‘PV world’, and potential impact on the role of QPPV
  • Network with colleagues and meet regulators
  • Learn from and share experience and ideas with like-minded QPPVs in a neutral environment
  • Take away practical hints and tips
  • Better understand regulatory and inspectorate expectations of the QPPV
  • Identify the expanded expectations of the role in the context of the new regulatory framework and transparency initiatives
  • Examine current areas of real challenge

Navitas’ Principal Consultant, Jeff Ho, will be presenting a poster presentation at this meeting titled ‘Efficient Content Management for the compilation and management of the PSMF’. This poster will evaluate the potential opportunities for efficient management of content utilised in the compilation and management of the PV System Master File.

To view the event programme, please click here

To arrange to meet with Jeff Ho, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

22
Sep 2016

Navitas Networks and AbbVie webinar PV Organisations Reimagined - Roadmap to transforming into a strategic PV organisation

Date: 22 September 2016
Time: 15:30 – 17:00 British Summer Time



Hosted by Navitas Networks and AbbVie, this webinar will be presented by Navitas’ Principal Consultant, Wilfred Gilich and, from AbbVie, Dr. Linda Scarazzini, Vice President PV and Patient Safety, Jenifer Koeller, Senior Director Business Solutions PV and Patient Safety, and Kemi Yusuf, Director Business Solutions Project Management PV and Patient Safety. The webinar will address the following:

  • The rapidly changing landscape for PV organisations
  • How PV organisations must respond
  • Anatomy of a strategic PV organisation
  • A case study from AbbVie
  • Roadmap to defining the PPS (Pharmacovigilance and Patient Safety) 2020 vision
  • Bringing PPS 2020 to life
  • Impact and results…so far
  • What lies ahead?
  • Key learnings for other PV organisations
  • Looking forward

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.

22
Sep 2016

Sparta Systems and Navitas Webinar: Addressing IDMP System Requirements with TrackWise

Date: 22 September 2016
Time: 11:00 ET



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.

Presenters
  • Scott Mitreuter, Product Management at Sparta Systems
  • David Gwyn, Head of Technology at Navitas, Inc.
Areas covered in the webinar
  • FDA and ISO requirements for IDMP
  • Establishment of an IDMP strategy
  • Develop a solution to meet the new IDMP guidelines
  • Integration between Sparta Systems’ TrackWise and Navitas

This webinar will provide insight for pharmaceutical companies on building a strong solution to meet the regulatory requirements of IDMP. To register your attendance please visit the event website here.

17
Sep 2016

RAPS 2016 Regulatory Convergence

Date: 17-20 September 2016
Venue: San Jose, California
RAPS 2016 Regulatory Convergence



Navitas will be highlighting regulatory solutions at the Regulatory Affairs Professionals Society annual meeting. IDMP is a popular topic with regulatory professionals and Navitas will showcase IDMP best practices along with idmpREADY Navitas will also provide attendees with case studies and demos of pharmaREADY, the end – to – end regulatory software suite, which is comprised of eCTD, Document Management, Structured Product Label Management, Training Records Management and Paper Submissions modules.

Navitas will also talk about regulatory submissions and publishing services. Navitas provides submission and publishing services for leading life science companies throughout the world and has regulatory operations hubs in India and Colombia.

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

12
Sep 2016

DIA Global Labeling 2016

Date: 12 -13 September 2016
Venue: Omni Shoreham Hotel, Washington DC, USA
DIA Global Labeling 2016



The DIA Global Labeling 2016 conference has been developed in collaboration with the Regulatory Affairs Community Labeling Working Group and will address the following topics:

  • Global Labeling issues and updates
  • Labeling role
  • Pharmacovigilance Risk Assessment
  • Packaging issues
  • Combination products
  • Biosimilars
  • Patient leaflet
  • Plain language labeling
  • Patient Medication Information (PMI)
  • International Strategic Plan
Navitas’ Senior Managing Consultant, Tara Baer, will be presenting at this conference on the topic of; ‘EU Issues; particularly looking at labeling for a combined medicinal product and medical device’. This is part of Session 3: Labeling for Combination Products and Devices taking place on Monday 12 September between 14:00 and 15:00.

For further information please visit the DIA event website here or to arrange to meet with Tara please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

07
Sep 2016

Navitas’ pvindia Webcast: Getting Inspection Ready

Date: 07 September 2016
Venue: 14:00 – 15:30 IST
pvindia



Hosted by Navitas’ pvindia Network, and presented by Louise Jebson, Head of Networks at Navitas Life Sciences and Jean-Christophe Delumeau, Head of Pharmacovigilance China and Asia Pacific at Bayer HealthCare, this webcast will explore the topic of ‘Getting Inspection Ready’. Staying abreast of what regulatory authorities require can be difficult to achieve. Success or failure of an inspection from a regulatory authority is determined by both practice and preparation. This webinar highlights the obstacles and pitfalls, strategy design, together with making inspection management a priority.

  • Latest Regulatory Context
  • Global trends and context
  • Emerging Indian regulations
  • A case study approach to Audits and Inspections -  Bayer HealthCare
  • 5 Steps to Inspection Readiness
  • An integrated approach and mindset
  • PSMF – core and local
  • Governance and roles
  • Compliance metrics and KPIs
  • Managing CAPAs
  • 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.

This webcast is hosted by Navitas’ pvindia Network; to find out more about pvindia please click here.

29
Aug 2016

CPhI’s Unannounced Audits Workshop

Date: 29-30 August 2016
Venue: The Westin Mumbai Garden City, Mumbai
CPhI’s Unannounced Audits Workshop



Navitas along with Sparta Systems is exhibiting at CPhI’s Unannounced Audits Workshop, which guarantees routine success in FDA inspections which would integrate company culture built on sustaining compliance, significant training and preparation, and flawless execution during the inspections. One can learn from leading USFDA pharma experts on managing audits in complex environments. Mohan Ponnudurai of Sparta Systems will be presenting on audit capabilities of TrackWise including risk assessments and compliance.

Visit our stand to know more about Navitas’ proprietary implementation framework – qualityREADY, designed to deploy TrackWise EQMS Application for your organization. This framework accelerates TrackWise implementations, reduces risks and lowers costs, brings industry best practices to business processes and provides flexibility to allow key configurations while ensuring audit readiness.

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

06
Jul 2016

Next Generation PV Tools’ webcast

Date: 06 July 2016
Time: 15:30 – 17:00 British Summer Time



Hosted by Navitas Networks, this webcast will be presented by Navitas’ Senior Consultant, Martin Holm-Petersen. The webcast will address the following:

  • IT as the game changer
  • Exploring macro-trends that are changing the technological landscape for Pharma
  • Technology drivers that are changing how we do PV
  • What does digitally transformed PV look like?
  • Automation, new sources of data, machine learning, and unstructured text analysis, generation of insights
  • Building IT strategies for PV
  • Drivers and challenges
  • Cross portfolio strategies
  • Roadmap for success

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.

26
Jun 2016

DIA 2016 52nd Annual Meeting

Date: 26 -30 June 2016
Venue: Pennsylvania Convention Center, Philadelphia, USA
DIA




Navitas is delighted to have three of our Expert Navigators presenting at the DIA’s 52nd Annual Meeting.

Tuesday 28 June, 2016 10:30 – 11:45

Navitas’ Managing Consultant, Hershell Thompson, will be chairing the session ‘The Global Conundrum: Herding Cats – Identifying Risk across Pharmacovigilance networks and seeking simplicity in multi-country Pharmacovigilance activities’

For further information please click here

Tuesday 28 June, 2016 16:00 – 17:15

Navitas’ Principal Consultant, Denis Fung, will be speaking as part of the ‘Improving Adverse Drug Reaction Information in Product Labels’ session

For further information please click here

Navitas will also be presenting a poster titled “End – to – End Change Control: An Integral Approach to Product Changes, Submissions and Variation Management”, which explains the basic concepts of End – to – End change control and provides key insights into the key benefits and challenges relating to End – to – End change control.

If you would like to arrange to meet with a member of our team at the DIA event then please do get in touch at This email address is being protected from spambots. You need JavaScript enabled to view it.

23
Jun 2016

pvconnect Forum

Date: 23 June 2016
Venue: London
labelnet



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. For further information or to register your interest in participating at this meeting, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

22
Jun 2016

pvtech Forum

Date: 22 June 2016
Venue: London
labelnet



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.

For further information or to register your interest in participating at this meeting, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

21
Jun 2016

pvnet Summit

Date: 21 June 2016
Venue: London
labelnet



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. For further information or to register your interest in participating at this meeting, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

16
Jun 2016

pvconnect Forum

Date: 16 June 2016
Venue: New York
labelnet



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. For further information or to register your interest in participating at this meeting, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

15
Jun 2016

labelnet Forum

Date: 15 - 16 June 2016
Venue: 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 to register your interest in participating, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

15
Jun 2016

pvtech Forum

Date: 15 June 2016
Venue: New York
labelnet



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.

14
Jun 2016

rimnet Forum

Date: 14 June 2016
Venue: New York
labelnet



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 in October, 2014 and May and June, 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.

14
Jun 2016

pvnet Summit

Date: 14 June 2016
Venue: New York
labelnet



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.

26
May 2016

Navitas - Oracle Webinar Series: Oracle Argus Implementations migrations, upgrades & maintenance
5th last webinar of this series - Application Management Services

Date: 26 May 2016
Time: 15:00 (BST), 16:00 (CEST), 10:00 (EDT)



Navitas’ Application Management Services (AMS) allow you to get the most out of your IT investments by reducing your cost of management and support, whilst increasing customer satisfaction and quality of service. This webinar will talk you through the Navitas application lifecycle approach.

Register Now!

25
May 2016

7th Outsourcing in Clinical Trials East Coast 2016

Date: 25 - 26 May 2016
Venue: King of Prussia, Pennsylvania
 7th Outsourcing in Clinical Trials East Coast 2016



Georgina Wood, Navitas’ Clinical Data Solutions Practice Lead, will speak at the 7th Annual Outsourcing in Clinical Trials East Coast conference May 25th & 26th in King of Prussia, Pennsylvania. According to research, the clinical outsourcing market will increase from $38 Billion to $64 Billion by 2020. The vendor selection process is time consuming, costly and often based on subjective criteria rather than on objective analysis. Ms. Wood will outline how companies can utilize industry best practices to improve their vendor selection process as well as improving their bottom line.

23
May 2016

Navitas Highlights Quality and IDMP at Sparta Connection Orlando

Date: 23 - 26 May 2016
Venue: JW Marriott Grande Lakes, Orlando, Florida
Sparta Connection



Navitas is a platinum sponsor at the Sparta Connection conference in Orlando, Florida May 23-26. Sparta Connection attendees will gain insights into how game-changing technology and strategies in mobile, SaaS and business analytics are propelling companies to new heights. Navitas will be highlighting qualityREADY®, which accelerates TrackWise implementations, reduces risks and lowers costs, brings industry best practices to business processes and provides flexibility to allow key configurations while ensuring audit readiness. Also highlighted will be idmpREADY®. idmpREADY is Navitas’ technology solution that enables life science companies to comply with coming regulations in Europe and throughout the world.

25
May 2016

rimnet Forum

Date: 25 May 2016
Venue: Sidley Austin LLP offices in London
labelnet



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 in October, 2014 and May and June, 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.

24
May 2016

labelnet Forum

Date: 24 May 2016
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 to register your interest in participating, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

11
May 2016

Navitas - Oracle Webinar Series: Oracle Argus Implementations migrations, upgrades & maintenance
4th webinar of this series - Increase your upgrades to reduce your cost and complexity

Date: 11 May 2016
Time: 15:00 (BST), 16:00 (CEST), 10:00 (EDT)



Navitas in partnership with Oracle is pleased to invite you to a series of Oracle Argus webinars. Whether you are considering an Oracle Argus implementation, looking to upgrade your existing system or want to consider your options for system maintenance, these webinars are for you. In this webinar we will talk you through Navitas’ forward thinking approach to system upgrades.

Register Now!

28
Apr 2016

Navitas - Oracle Webinar Series: Oracle Argus Implementations migrations, upgrades & maintenance
3rd webinar of this series - Data Migration

Date: 28 April 2016
Time: 15:00 (BST), 16:00 (CEST), 10:00 (EDT)



Navitas in partnership with Oracle is pleased to invite you to a series of Oracle Argus webinars. Whether you are considering an Oracle Argus implementation, looking to upgrade your existing system or want to consider your options for system maintenance, these webinars are for you. Migrating legacy safety applications can be a daunting task due to the complexities involved. Navitas has prebuilt migration packages that enable rapid, compliant migrations from legacy applications (as well as Excel spreadsheets) to help smooth your implementation and provide peace of mind.

Register Now!

26
Apr 2016

2016 Blue User Conference

Date: 26 April 2016
Venue: Chicago Athletic Association Hotel, Chicago, IL



Tara Baer from Navitas speaks at the 2016 Blue User Conference. Tara Baer, labeling expert from Navitas, will present “Breaking Down the Walls for a Better Process” on April 26th at 8:45 a.m.

Tara is an experienced leader in Medical Device and Pharmaceutical labeling. She has worked at such industry leaders as AbbVie, Boston Scientific, Wyeth and Intervet, where she developed a passion for End-to-End Labeling Management, from safety through distribution. An experienced manager, guide and motivator, she has led diverse teams of professionals towards collaborative solutions. Tara has a proven record of accomplishment of successfully delivering projects with aggressive timelines and budgets, with a focus on risk and quality management. She specializes in translation management, workflow, content development, automated tracking/process integration, and asset management.

21
Apr 2016

CPhI’s CAPA & Root Cause Investigation Workshop

Date: 21 - 22 April 2016
Venue: Meluha The Fern, Mumbai, India
CPhI’s CAPA & Root Cause Investigation Workshop



Navitas along with Sparta Systems is exhibiting at CPhI’s CAPA & Root Cause Investigation Workshop, which 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. Mohan Ponnudurai of Sparta Systems is a speaker at this event.

Visit our stand to know more about Navitas’ proprietary implementation framework – qualityREADY, designed to deploy TrackWise EQMS Application for your organization. This framework ensures high quality regulatory compliant deployment within a short timeframe. This framework comprises of accelerators for Process Design, Configuration, Validation, Data Migration and Training.

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

20
Apr 2016

Navitas - Oracle Webinar Series: Oracle Argus Implementations migrations, upgrades & maintenance
2nd webinar of this series - Accelerated Oracle Argus Implementations

Date: 20 April 2016
Time: 15:00 (BST), 16:00 (CEST), 10:00 (EDT)



Navitas in partnership with Oracle is pleased to invite you to a series of Oracle Argus webinars. Whether you are considering an Oracle Argus implementation, looking to upgrade your existing system or want to consider your options for system maintenance, these webinars are for you. This webinar will explain how our accelerators can fast track your Oracle Argus implementation whilst ensuring it is tailored to your specific business requirements.

Register Now!

20
Apr 2016

India - TrackWise User Group (TUG)

Date: 20 April 2016
Venue: Hyatt Regency, Mumbai
India - TrackWise User Group (TUG)



Navitas and Sparta Systems will host the 2nd TrackWise User Group (TUG) meeting on 20th April 2016 at the Hyatt Regency, Mumbai. The event is a platform for TrackWise users across India to connect and share their experiences and best practices. Users can also learn from experts on how to get more from their investments in TrackWise.

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

14
Apr 2016

Labelling End-to-End Tracking Tools in Action Webcast

Date: 14 April 2016
Time: 15:30 – 17:00 BST



Hosted by Navitas Networks, this webcast will be presented by David Gwyn, Head Technology Practice at Navitas Life Sciences, Inc. and Craig Trautman, CEO, Intagras. The webcast will address the following:

  • A reminder of why E2E tracking is key
  • The start and end point of labelling
  • Tracking tools in action
  • Looking forward

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.

13
Apr 2016

The Digital Transformation in Pharma

Date: 13 - 14 April 2016
Venue: Tivoli Hotel and Congress Center, Copenhagen, Denmark
The Digital Transformation in Pharma



Navitas’ Senior Consultant, Martin Holm-Petersen, will be presenting a session titled ‘Realigning pharma – patient data driven scenarios’ on Wednesday 13 April from 11:00 – 11:45. This session will explore how pharma companies are looking for future opportunities emerging from new data sources. It will explore scenarios as well as a case study for bringing patient/consumers closer to the business via mHealth and personal health records. The session will also discuss:

  • How real-world evidence will integrate in the pharma value chain
  • How it will impact the pharma business operating model and cause internal realignment within organisations
06
Apr 2016

Navitas - Oracle Webinar series: Oracle Argus Implementations, migrations, upgrades and maintenance

Date: 06 April 2016
Time: 15:00 (BST), 16:00 (CEST), 10:00 (EDT)



Navitas in partnership with Oracle is pleased to invite you to a series of Oracle Argus webinars. Whether you are considering an Oracle Argus implementation, looking to upgrade your existing system or want to consider your options for system maintenance, these webinars are for you.

First of the series is Oracle Argus in the Cloud. This webinar will talk you through the advantages of cloud implementations, our expedited approach to implementation and the options open to you.

Register Now!

31
Mar 2016

IDMP - From Concept to Reality Webcast

Date: 31 March 2016
Time: 15:30 – 17:00 BST



Hosted by Navitas Networks, this webcast will be presented by Rens van den Boomen, Managing Consultant at Navitas Life Sciences and will address the following:

  • Latest Regulatory context for IDMP
  • IDMP – 5 steps to success
  • Maturity Assessment
  • Strategy Roadmap
  • Program Management
  • System Implementation
  • IDMP Deployment
  • Where next?
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.

22
Mar 2016

5th Annual Clinical Data Integration and Management 2016

Date: 22 March 2016
Venue: Princeton, New Jersey
5th Annual clinical data integration and management



Georgina Wood, Clinical Data Practice Leader for Navitas, will present “Clinical Data Integration – Integral to Risk Based Monitoring, Quality based payments and SDTM like outputs” at the 5th Annual Clinical Data Integration & Management conference Tuesday, March 22nd in Princeton, New Jersey.

Her session will discuss how to establish next generation clinical analytics by incorporating a robust clinical data integration platform as an essential and pre-requisite foundational architectural component. Realizing differences in scope and complexity of integration across enterprises by adopting SaaS based data collection and clinical trials management systems will be explored. Also covered will be:

  • Analyzing a custom development of a data warehouse with scope of integrating data from output for operational and bio-statistical programing needs
  • Discussing a SaaS based integration platform with the scope of integration across all systems enabling adaptive monitoring (RBM with Central and Medical Monitoring)

This session will take place at 11:30 on Tuesday, March 22nd.

17
Mar 2016

Pharmacovigilance 2016

Date: 17 March 2016
Venue: DGI-byen Conference Centre, Copenhagen, Denmark
Pharmacovigilance 2016



Navitas’ Senior Consultant, Martin Holm-Petersen, will be part of an expert panel discussion on PASS and PAES designs at this event. The session will explore:

  • Secondary use of health data
  • Use of big data sources in PV – how far are we?
  • Data driven pharmacovigilance and elaborate post authorisation monitoring of benefit-risk in the market has been conceptualised, but how far are we in the industry?
  • Industry perspectives – a hot topic

For further information please visit the event website at: http://insightevents.dk/events/pharmacovigilance-2016/

06
Mar 2016
Date: 06 - 09 March 2016
Venue: JW Marriott San Antonio Hill Country, San Antonio, Texas
HDMA



Navitas will be highlighting its traceREADY Warehouse Edge System at the HDMA Conference. HDMA is the national association representing primary healthcare distributors, the link between the nation’s pharmaceutical manufacturers and healthcare providers.

Navitas’ traceREADY Warehouse Edge System enables the capture of serialized warehouse transactions which regulations mandate the recording of all business events in a centralized repository for enabling Track and Trace for supply chain security.

In order to ensure accurate and timely data from the packaging line, it is necessary to have an application to collect the required data and transfer the same to the central repository.

traceREADY automates warehouse / manufacturing transactions, meets validation requirements and complies with GxP norms, supports multiple form factors on Windows, Android and iOS devices and enables online and offline mobile transactions. traceREADY was designed to be a highly configurable and scalable architecture and integrates seamlessly with ERP (SAP, Oracle, JDE) and EPCIS repositories.

To learn more or to view a demo, visit Navitas in booth 112 at the HDMA conference.

03
Mar 2016

pvindia Forum

Date: 03 March 2016
Venue: Mumbai, India
pvindia



Navitas is delighted to announce that we will soon be adding to our portfolio of industry leading networks with the launch of pvindia; a network for Heads of Safety of Indian life sciences companies with pharma, consumer, generics, or mixed portfolios.

pvindia will leverage the approach, format and experience gained from successfully running pvnetworks over the past 14 years in Europe and the USA. This is a unique opportunity to be part of the industry leading global network for pharmacovigilance professionals.

pvindia will provide 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. For further information please click here to register your interest in participating, please contact a member of our networks team at This email address is being protected from spambots. You need JavaScript enabled to view it.

24
Feb 2016

Pharma Packaging and Labeling USA 2016

Date: 24 – 25 February 2016
Venue: Philadelphia, USA
labelnet



Navitas Speaking at the Pharma Packaging and Labeling USA 2016.

Navitas will present innovative packaging and labelling strategies and tactics at the Pharma Packaging and Labeling USA 2016 conference. David Gwyn, Navitas’ technology practice leader, will discuss models for success for effective labelling that aligns across functions to deliver a compliant, label management process.

18
Feb 2016

Global PV Connections - Managing across borders Webcast

Date: 18 February 2016
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 Jeffrey Ho, Principal, Navitas Life Sciences

  • Building global connections
  • Managing across borders - affiliates and partners
  • Assessing risk and resource needs
  • Strategies for success

Speaker to be confirmed

  • The shifting global PV context
  • Shifting regulations and a complex landscape
  • Rising volumes and headcount squeeze

Presented by Lesia Tontisakis, Director of PV, Allergan

  • Case Study: Developing an improvement plan; preventing pitfalls and realising benefits
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..
04
Feb 2016

ECCRT Seminar: Outsourcing models in Clinical R&D

Date: 04 February 2016
Venue: Pullman Hotel - Place Victor Horta 1 - 1060 Brussels
ECCRT



Navitas’ Shalabh Kumar to speak at the European Centre for Clinical Research Training

Shalabh Kumar, Navitas’ Global Head of Outsourcing Services, will speak at the February 4th European Centre for Clinical Research Training seminar at the Pullman Hotel in Brussels. Mr. Kumar, along with Eric Chleide and David Baugnies of GSK Vaccines, will explore the benefits and possible pitfalls of Clinical R’D outsourcing models.

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