>GVP Module V Training Day

  • Venue: British Medical Association, London
  • Date: 18 Jan 2018
  • Cost per delegate:
    • Or £595 + VAT standard

      (Standard registration)

    • Or £387 + VAT academic

      (Academic units, public sector organisations, registered charities)

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The revision of GVP Module V on Risk Management Systems came into force on 31st March 2017. The newly updated module now includes clarification of the scope of RMPs in relation to important identified or potential risks and missing information. In addition the revision includes further guidance on the expected changes in the RMP during the life cycle of a product and updated requirements for different types of initial marketing authorisation applications, with the aim to create risk-proportionate RMPs.

Join us for a day of training on all aspects of GVP Module V, concentrating on the application of the revisions, provided by experts from pharma and the EMA. The programme will include presentations from members of the EMA team who wrote the revised Module V and the updated RMP template, as well as talks from pharma risk management experts on the practicalities of the changes and the impact on the RMP life-cycle. There will be an interactive Q&A session, providing delegates with the opportunity to ask questions of the speakers.

Programme available here

Confirmed speakers:

  • Emil Cochino, EMA
  • Jane Feron, AstraZeneca
  • Nuria Semis-Costa, EMA
  • Saad Shakir, DSRU
  • Peter de Veene, Grunenthal
  • Phillip Eichorn, Pfizer