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Free Webinar: EudraVigilance changes and the impact on MAHs

Published on 13/10/17 at 09:07am

Following on from the popularity of our previous free webinar sessions, Pharmafocus is once again partnering with PrimeVigilance to bring you an overview of the EudraVigilance changes and their impact on MAHs.

PrimeVigilance’s Ivana Sutalo, Senior PV Project Manager, will cover the new EV simplified reporting requirements, EV Access levels for MAHs, download and processing of ICSRs from EV, expected workload increase, importance of prompt updates to XEVMPD, changes to MLM case management, type of EV registrations and impact of new EV requirements on partner agreements.

Finally, the webinar will outline some challenges of E2B (R3) conversions and pragmatic processing of all source data that is made available in E2B (R3) format in a safety database which operates with E2B (R2) format, and highlight the key considerations that can help streamline the process and meet the regulatory (GVP VI) requirements.

Key topics covered in this webinar include:

  • Simplified EV reporting requirements
  • EV Access levels for MAHs
  • Downloading/processing ICSRs from EV

The webinar will begin at 3pm GMT, 4pm CET, 10am EST, 11am EDT, on Tuesday the 7th of November.

Click here to book your place today. If you require further information, please do not hesitate to contact us.

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