PrimeVigilance is pleased to announce that Dr. Cvijeta Bielen, our Medical Director, will be running a new webinar as a follow-up to the webinar titled “EVDAS outputs are available to MAHs – what now?” This Part 2 session takes place on Thursday 14th of June 2018 starting at 3 pm GMT (UK), 4 pm CET (Europe), and 10 am EDT (US).

This follow up webinar will provide an overview of the discussion taking place during this pilot period as well as some figures estimating upcoming workload. We are collecting feedback from regulatory inspectorates to better understand their standpoint with regards to the “grey zones” with highest impact on workload.

Key topics covered in this webinar include:

  • What exactly needs to be considered during signal validations vs. further signal assessments?
  • For which cases is it necessary to request L2B access?
  • Whether to store these reports into safety databases.
  • Are the expectations from generic companies any different?

The webinar will be followed by a Q&A session where you will be able to ask questions and receive direct feedback on key areas of uncertainty.

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

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