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14th Jun 2019, 08:36 PM
#3
Obviously the MHRA SB guidance is a good place to look. I should warn you that the EMA draft guidance on SB (on the Inspection Working Group website) which is based on the MHRA guidance, does not include the MHRA "pragmatic" approach to clock start. Unless things change by the final guidance, it looks like they are playing "hard ball" in wanting reporting 7 days after first knowledge of the event. Obviously there needs to be a robust deviation escalation process so that all potential SBs are evaluated and reported if they are possible SBs.
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