News/Events

Monday 05 December 2011 Seminar in Paris: PV information management in a regulated environment


At this occasion, Erick Gaussens, Scientific Chief Officer  at ProductLife Group and Dr Stephen Bentley Chairman of Verius (Member of ProductLife Group) will run presentations about PV information management.


Objectives

 

  • To define all criteria of PV information management
  • To analyse the impact of the new PV regulation on companies organisation
  • To determine a process to guarantee collect and treatment of information : from development to PV

 Agenda

 

  • 9.00 am: Open discussion with the attendees to understand their needs
  • 9.30 am:  Collect and treatment of PV information (by Stephen Bentley - Verius)
  • 10.30 am: Impact of the new regulation on information management (by Eric Caugant - Alexion)
  • 11.15 am: In the context of the new regulation, evolution of Eudravigilance (by François Maignen - EMA)
  • 12.30 am: Q/A with the speakers
  • 2.00 pm: How to follow the information: from devlopment to PV: IPSEN case (by Mathias Ganz - IPSEN)
  • 2.45 pm: How to follow the information: from development to PV: Novartis case (by Annick Thomas-Krebs - Novartis)
  • 3.45 pm: Workshop - What are the impacts of the new information management on the activity and IS in PV

  • 4.15 pm: Discussion about the workshop
  • 4.45 pm: Constraints of standardization, networking and validation
  • 5.15 pm: End of the seminar

To register, please complete the registration form and click on the link: Programme et formulaire d inscription.pdf

 

 

 

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