Search results with tag "Guidance document for assessors"

Q & A on PSUSA: Guidance document for assessors

An explanatory note to GVP Module VII for MAH has been developed ... consultation with a Scientific Advisory Group/Ad-hoc expert group. Page 3/13 1.2. Strength of evidence in the context of the stage in the product lifecycle ... not adequately addressed, the LMS can request the MAH to provide the supporting data during the PSUR assessment ...

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