Regulatory Open Forum

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  • 1.  Convergence 2020 - Europe Forum

    Posted 09-Sep-2020 14:04

    I am leading the Europe Forum session at RAPS 2020 Convergence on Monday, 14 September from 10:00-11:30 am, EDT. If you are planning to join the session (or even if you aren't), I am interested in your feedback on the following questions to help the panel prepare.

     

    1. Are there any specific questions you have about the EU regulatory system?
    2. What is your level of knowledge/ experience with EU regulatory procedures, EMA and CHMP?
      1. No knowledge/ experience at all
      2. Some knowledge and experience
      3. Very good knowledge and experienced


    #RAPSConvergence​​

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    Sabine Haubenreisser
    Principal Scientific Administrator
    Amsterdam
    Netherlands
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  • 2.  RE: Convergence 2020 - Europe Forum

    Posted 10-Sep-2020 15:25
    Hello! I plan to attend and look forward to meeting you. 
    1. Are there any specific questions you have about the EU regulatory system? Can you provide some general discussion of the differences between the Notified Bodies' expectations and practices?
    2. What is your level of knowledge/ experience with EU regulatory procedures, EMA and CHMP? EU-3, EMA-1, CHMP-1


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      Karen Bannick McQuoid MA, FRAPS, RAC, FRAPS
      CEO
      karen@bannickprimary.com
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