News/Events

Friday 09 December 2011 Business Breakfast in Paris: The new EMA guidance on EVMPD - At 6 months of the XEVPRM deadline, where are we?


This business breakfast will be run by Wim Cypers, Vice President, Regulatory Business Unit - Aris Global and Erick Gaussens, Chief Scientific Officer - ProductLife Group. The presentation will be based on the works of ProductLife task Force on ePV led by Sophie Daniel, Consulting Operation Director - ProductLife SARL and Marie Fasehun, Pharmacovigilance Manager - Verius Limited, a company of ProductLife Group SA.


The European Medicines Agency (EMA) is currently implementing a new set of EVMPD regulations, but how to be prepared? Will Pharma companies be ready? Will the EMA be ready? Is the impact of such a directive now understood by Pharma companies? Considering the scope and tight deadline (July 2, 2012), Aris Global will present how we can help you to manage and address this challenge and will give you more clarification on:

  • EVMPD
    - Purpose & Regulatory Basis
    - Content & Structure
  • Actions needed to be compliant
  • Future Regulatory Requirements
  • EVMPD to IDMP Convergence on New Standards

During this event, we shall address these questions under two approaches: ProductLife will present you the vision to the above challenges from a service view including consultancy to staff augmentation through outsourced service platform. Aris Global will further highlight how to achieve compliance and introduce you to their innovative solutions Register™ and agXchange™ RSM - helping you to stay ahead of these regulatory changes while lowering costs and optimizing your processes. Register™ is a market-leading solution for regulatory information management; agXchange RSM is a proven solution for eVMPD-compliant submissions.

 

Agenda

 

08.30 am: Registration & Coffee

09.00 am: Beginning of the presentation

10.30 am: Exchange with the speakers

11.00 am: End of the event

 

Location

 

Aéroclub de France

6 rue Galilée

75116 Paris

 

Registration conditions

 

The attendance is free of charge. Because of limited space, we kindly ask you to register before December 5th.

 

Online Event Registration avec amiando

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