>GVP Module IX Training Day

  • Venue: Novotel London West Hotel, Hammersmith, London
  • Date: 20 Mar 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 revised Module IX now includes updated guidance on monitoring of EudraVigilance data and clarification for MAHs on handling signals detected in EudraVigilance data, as well as other information on roles, responsibilities and definitions. Join us for a day of training on all aspects of GVP Module IX, concentrating on the application of the revisions, provided by experts from pharma and the EMA.

The training day will guide delegates through the detail of the changes and how to implement them. Delegates will hear from an EMA signal management expert about development of the Revision and its pilot, as well as information about the responsibilities of the EMA under GVP Module IX, including PRAC assessment. The course will also cover the process for emerging safety issues (which was previously included in GVP Module VI) and will link signal management to PSURs by demonstrating how to decide which signals are emerging. There will be an interactive Q&A session, providing delegates with the opportunity to ask questions of the expert speakers.

Programme available here

Confirmed speakers:

  • Andrej Segec, EMA
  • Shelley Gandhi, NDA Regulatory Science Ltd
  • Saad Shakir, DSRU
  • Sue Rees, Amgen