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Jul 192 min read

EMA Guidance: EudraVigilance Registration Manual

Yesterday the European Medicines Agency (EMA) provided an updated comprehensive guidance on EudraVigilance registration through its...

May 172 min read

EMA Guidance: EudraVigilance Registration Documents

The European Medicines Agency (EMA) on Thursday (16 May, 2024) released an updated guidance on "EudraVigilance Registration Documents"...

Aug 25, 20221 min read

EMA: Updated EudraVigilance Registration Manual

EudraVigilance is the system for managing and analysing information on suspected adverse reactions to medicines which have been...

Mar 23, 20221 min read

EMA Guidance on Post-Authorisation Procedural Advice for CAP users & EudraVigilance Reg. Manual

On 18 March 2022, EMA released updated guidance on "European Medicines Agency post-authorisation procedural advice for users of the...