07
Dec 2017

Live Webinar: BA/BE Studies Best Practices – Gaining the First to File Advantage

Date: 07 December 2017
Time: 1100 EST /1600 UK Time




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

06
Dec 2017

Navitas Networks Webinar: GVP Module IX update – Impact beyond borders

Date: 06 December 2017
Time: 115:30 – 17:00 GMT




Agenda:

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

28
Nov 2017

Partnerships in Clinical Trials Europe

Date: 28 - 29 November 2017
Venue: Amsterdam RAI Exhibition and Convention Center – Stand 87




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

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

16
Nov 2017

pvconnect Forum - Autumn

Date: 16 November 2017
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.

Focussing on themes in building a borderless, networked PV ecosystem

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

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

15
Nov 2017

labelnet Forum - Autumn

Date: 15 November 2017
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).

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

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

15
Nov 2017

pvtech Forum - Autumn

Date: 15 November 2017
Venue: 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.

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

PV tools for today and getting fit for the future

  • The latest context: EU (GDPR) update, Brexit and the QPPV, Benchmark insights
  • Exploration of PV compliance monitoring tools
  • PV ecosystem applications and SDB integration approaches 
  • A temperature check on EudraVigilance / E2B(R3) implementations
  • PV ecosystem and scanning applications around the safety database
  • Clinical to safety – integrating the clinical systems with the safety database
  • Update from our Automation Working Group and kick-off for Digital WG
For further information or to register to attend please contact This email address is being protected from spambots. You need JavaScript enabled to view it.

14
Nov 2017

rimnet Forum - Autumn

Date: 14 November 2017
Venue: 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.

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

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

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

14
Nov 2017

pvnet Summit – Autumn

Date: 14 November 2017
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.

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

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

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

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

09
Nov 2017

pvconnect Forum - Autumn

Date: 09 November 2017
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.

Focussing on themes in building a borderless, networked PV ecosystem

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

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

08
Nov 2017

labelnet Forum - Autumn

Date: 08 November 2017
Venue: 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).

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

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

08
Nov 2017

pvtech Forum - Autumn

Date: 08 November 2017
Venue: 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.

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

PV tools for today and getting fit for the future

  • The latest context: EU (GDPR) update, Brexit and the QPPV, Benchmark insights
  • Exploration of PV compliance monitoring tools
  • PV ecosystem applications and SDB integration approaches 
  • A temperature check on EudraVigilance / E2B(R3) implementations
  • PV ecosystem and scanning applications around the safety database
  • Clinical to safety – integrating the clinical systems with the safety database
  • Update from our Automation Working Group and kick-off for Digital WG
For further information or to register to attend please contact This email address is being protected from spambots. You need JavaScript enabled to view it.

07
Nov 2017

pvnet Summit – Autumn

Date: 07 November 2017
Venue: 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.

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

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

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



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

07
Nov 2017

rimnet Forum - Autumn

Date: 07 November 2017
Venue: 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 and London with participation from 13 companies. The positive feedback from the participants, and the need for further discussion led to events being held twice a year since in both locations.

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

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

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

24
Oct 2017

CPhI Worldwide

Date: 24 - 26 October 2017
Venue: Messe Frankfurt, Germany / Stand No: 41M13



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

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

Stand 41N04 is located in the CRO & Clinical Trials Gold Zone in in Hall 4.1. For more information or to arrange a meeting at the conference, contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

25
Oct 2017

pvindia Forum – Autumn

Date: 25th October 2017
Venue: ITC Maratha, Mumbai
pvindia



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

What topics will the forum cover?

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

12
Oct 2017

Navitas Networks Webinar: RIM Maturity Pathway – achieving your RIM goals using the RIM Maturity Model

Date: 12th October 2017
Time: 15:30 – 17:00 GMT



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

Agenda:

  • Understand the RIM Maturity model dimensions
  • Understand how to use the maturity model to plan future investment
  • Understand the need to manage stakeholders and build the business case for change
Looking forward To register please click here

19
Sep 2017

Navitas webinar series on ICH E6 GCP compliance
2nd webinar of this series: Adopting the new ICH E6 GCP regulations impacts clinical trial outcomes positively

Date: 19th September 2017
Time: 15:30 UK / 16:30 CET / 10:30 EST / 7:30 PST / 20:00 IST



Agenda:

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

14
Sep 2017

Navitas Networks Webinar on: The safety database in a pharma company – tactical considerations for delivering on compliance and efficiency

Date: 14th September 2017
Time: 11:30am -13:00pm GMT | 4:00pm to 5:00pm IST



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

Agenda:

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

13
Sep 2017

Navitas Networks Webinar On: Labeling Organization – Simplicity or Specialism?

Date: 13th September 2017
Time: 15:30 – 17:00 GMT



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

Agenda:

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

30
Aug 2017

Navitas Networks Webinar on: End to End Labeling Technologies - Looking Forward

Date: 30th August 2017
Time: 15:30 – 17:00 GMT



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

Agenda:

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

25
Jul 2017

Navitas webinar series on ICH E6 GCP compliance
1st webinar of the series: Impact of ICH E.6 addendum on Quality for Sponsors (or Quality by Design in Clinical development)

Date: 25th July 2017
Time: 15:30 UK / 16:30 CET / 10:30 EST / 7:30 PST / 20:00 IST



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

Agenda:

  • What is Quality by Design?
  • Regulatory perspective
  • Drivers for quality in the pharmaceutical industry 
  • What can we learn about Quality by design from the manufacturing industry?
  • The importance of design, control and improve.
  • Application at the project and trial level
  • Applying Quality by Design learning in manufacturing to clinical trial management
  • Risk assessments
  • Quality tolerance limits
  • Continuous process improvement
To register please click here

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

20
Jul 2017

Navitas networks webinar On: The safety database in a pharma company – tactical considerations for delivering on compliance and efficiency

Date: 20th July 2017
Time: 15:30 – 17:00 GMT



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

Agenda:

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

21
Jun 2017

DIA 2017 Annual Meeting

Date: 21st June 2017
Venue: Chicago, IL
DIA 2017 Annual Meeting



Navitas presents at DIA Annual Meeting in Chicago.

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

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

For more information on the sessions, click here.

To arrange a meeting with Navitas pharmacovigilance experts, click This email address is being protected from spambots. You need JavaScript enabled to view it..

15
Jun 2017

pvconnect forum spring London

Date: 15 June 2017
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.

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

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

14
Jun 2017

pvtech Forum - Spring

Date: 14 June 2017
Venue: 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.

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

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

08
Jun 2017

pvtech Forum - Spring

Date: 08 June 2017
Venue: 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.

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

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

08
Jun 2017

rimnet Forum - Spring

Date: 08 June 2017
Venue: 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.

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

For further information or to register to attend please contactThis email address is being protected from spambots. You need JavaScript enabled to view it.

07
Jun 2017

pvnet Strategic Summit - Spring

Date: 07 June 2017
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.

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

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

07
Jun 2017

pvconnect Forum - Spring

Date: 07 June 2017
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.

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

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

07
Jun 2017

labelnet Forum - Spring

Date: 07 June 2017
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).

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

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

07
Jun 2017

cmonet strategic summit

Date: 07 June 2017
Venue: New York
labelnet



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

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

25
May 2017

CPhI’s 2nd Annual CAPA & Root Cause Investigation Workshop

Date: 25-26 May 2017
Venue: Mumbai



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

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

24
May 2017

Webinar - FDA’s Requirements for eCTD Submissions

Date: Wednesday 24th May 2017
Time: 2 PM EST



Webinar will cover:

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

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

18
May 2017

rimnet Forum - Spring

Date: 18 May 2017
Venue: 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 and London with participation from 13 companies. The positive feedback from the participants, and the need for further discussion led to events being held twice a year since in both locations.

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

For further information or to register to attend please contactThis email address is being protected from spambots. You need JavaScript enabled to view it.

16
May 2017

labelnet Forum - Spring

Date: 16-17 May 2017
Venue: 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).

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

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

08
May 2017

Webinar hosted by Navitas Networks: Evolving IDMP Guidelines

Date: Monday 8th May 2017
Time: 15:30 – 17:00 GMT



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

Agenda:

  • The evolving IDMP guidelines
  • Key requirements
  • Expected timelines
  • What it means in reality?
  • 5 steps to IDMP readiness – a pyramid for success
  • Data management
  • Governance, Organisation
  • Process and Technology
  • So what and where next?
  • Benefit or burden?
  • Where will it lead?
  • Q & A, Close
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
May 2017

Webinar hosted by Navitas Networks: Transitioning into a new era of Risk Management in Europe

Date: Thursday 4th May 2017
Time: 15:30-17:00 GMT



Agenda:

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

25
Apr 2017

eRegulatory Summit

Date: 25-27 April 2017
Venue: Hotel Meliá Avenida América, Madrid



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

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

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

24
Apr 2017

Webinar hosted by Navitas Networks: PLLR – many questions, some answers

Date: 24 April 2017
Time: 15:30 – 17:00 GMT



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

Agenda:

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

19
Apr 2017

India - TrackWise User Group (TUG)

Date: 19 April 2017
Venue: ITC Maratha, Mumbai
India - TrackWise User Group (TUG)



Navitas and Sparta Systems will host the 3rd TrackWise User Group (TUG) meeting on 19th April 2017 in 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.

20
Mar 2017

Oracle Industry Connect Conference 2017

Date: 20 - 22 March 2017
Venue: Orlando, Florida
Oracle Industry Connect Conference 2017



Navitas Multi-Tenant Argus SafetyREADY™ Shared Cloud at Oracle’s Industry Connect Conference
Navitas will be highlighting the SafetyREADY Shared Cloud at the Oracle Industry Connect conference. Traditional deployments of Oracle Argus Safety have meant high implementation, infrastructure and maintenance costs that are prohibitive for many companies. Additionally, Oracle’s case based licensing model means that companies with low case volumes pay for volume that they will not use.

The SafetyREADY™ Shared Cloud utilizes the benefits for multi-tenant cloud sharing, which offers a cost-effective solution (saving more than 50%) for companies with smaller case volumes. Navitas invests in infrastructure and licensing on client’s behalf and reduces implementation costs by utilizing our pre-validated and pre-configured “gold instance”. The flexible costing model adapts to clients changing case volumes over time, clients only pay for what they need.

To learn more, visit Navitas at the Oracle Industry Connect conference in the Life Science pavilion.

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.

16
Mar 2017

pvindia Forum - Spring

Date: 16 March, 2017
Venue: Mumbai, India
pvindia



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

  • What topics will the forum cover?
  • The latest PV Regulatory context – balancing global and local requirements
  • Update on the global context: FDA, EMA latest PV regulations
  • Deep dive and industry discussion on the proposed PvPI guidelines (building on previous discussion in October)
  • An operational PV perspective, with case studies and discussions
    How to move the community forward

05
Mar 2017

HDA’s 2017 Distribution Management Conference and Expo

Date: 05 – 08 March 2017
Venue: JW Marriott Desert Springs, Palm Desert, California, USA
HDA’s 2017 Distribution Management Conference and Expo



Navitas will be demonstrating traceREADY in booth 108 at HDA’s 2017 Distribution Management Conference and Expo. 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.

22
Feb 2017

Webinar hosted by Navitas Networks: E2E labeling – Achieving Global Consistency

Date: 22 February, 2017
Time: 15:30 – 17:00 GMT



Hosted by Navitas Networks this webinar E2E labeling – Achieving Global Consistency will be presented by Tara Baer, one of our expert navigators here at Navitas.

Agenda:

  • The Global labeling Context
  • Trends, drivers, expanding horizons
  • The need for a global approach
  • Building Global connections
  • Labelling – through the eyes of an affiliate / a global perspective
  • The evolving Technology landscape – a global/local E2E view
  • A practical experience
  • Looking forward
  • ​What is on the horizon?

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.

21
Feb 2017

Sidley pvlegal Biannual Meeting

Date: 21-22 February, 2017
Venue: ALK Abelló offices, Hørsholm, Denmark
rimnet



Navitas’ Senior Consultant, Martin Holm-Petersen, will be attending this conference as a delegate.

This interactive meeting will include hot topics in drug and device safety reporting, panel discussions, benchmarking trends, and case studies.

pvlegal is a membership-based forum for in-house counsel and compliance personnel working on pharmacovigilance issues in the Life Sciences sector. This is supported by regular benchmarking of member performance and best practice sharing in the area of drug and device safety reporting. For more information about pvlegal please visit the network website here or contact a member of the pvlegal team at This email address is being protected from spambots. You need JavaScript enabled to view it. or to arrange to meet with Martin please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

08
Feb 2017

DIA’s Regulatory Submissions, Information, and Document Management Forum

Date: 08 - 10 February 2017
Venue: Bethesda, Maryland, USA
rimnet



Navitas will join life science executives from companies such as Amgen, Bristol-Myers Squibb, Pfizer, Teva, and more at DIA’s Regulatory Submissions, Information, and Document Management Forum in Bethesda, Maryland.

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

24
Jan 2017

Navitas and Sparta Systems - EQMS Webinar Series

Date: 24 January 2017
Time: 11:00 am – 12:00 pm IST



1st Webinar of the Series - Ensuring Data Integrity, Mitigating Risk and Quality Metrics

This webinar will address the key challenges life sciences’ manufacturers face and the importance of:

  • Managing quality processes, data and ‘metrics’ consistently and accurately
  • A Quality Management System (QMS) with inherent analytical capabilities:
  • Reduces audit time and findings
  • Decreases risk of product recalls
  • Enables better decisions faster without the high costs of implementing and maintaining an external business intelligence solution

Followed by hands-on live demo of TrackWise Solution.

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.

09
Jan 2017

Sidley Network Events: Inside The Minds of Regulators: Perspectives on Eu Pharmaceutical and Medical Devices Law

Date: 09 January 2017
Venue: The Hotel Brussels, Belguim



Please join us for an inside look at how the latest legal and regulatory developments in EU law will affect companies operating in the life sciences space. We will bring together senior members of the European Commission and regulatory and business community to address the potential impact of new pharmaceutical and medical devices legislation and regulation. Sessions will cover medicinal products, including clinical trials, pharmacovigilance and orphan medicinal products, and medical and in vitro diagnostic devices, as well as competition law issues affecting the pharmaceutical sector. Our panelists/speakers will also discuss the foreseeable impact of Brexit on the life sciences industry.

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.

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