Key market opportunities include developing comprehensive risk-based pharmacovigilance (PV) audit strategies aligned with EMA and FDA guidelines. Focus areas involve designing PV audit plans, risk ...
The European Medicines Agency (EMA) on Wednesday released draft versions of the third revision to its good pharmacovigilance practice (GVP) module XVI guideline on risk minimization measures and its ...
The EMA released the revised Module V- Risk Management Systems (Rev 2) of Good Pharmacovigilance Practice (GVP) (EMA/838713/2011 Rev 2) accompanied by a revised Guidance on the format of the risk ...
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