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This episode covers the most important updates introduced in the new EU Implementing Regulation 2025/1466.
We look at changes in PV audits, subcontractor responsibilities, Eudravigilance monitoring, and the end of the signal detection pilot for MAHs.
A quick, clear breakdown of what matters and what to do next.
Link: Commission Implementing Regulation (EU) 2025/1466 of 22 July 2025 amending Implementing Regulation (EU) No 520/2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and of the Council
Q&A: Questions and answers on termination of MAH EV pilot
By Julia AppelskogThis episode covers the most important updates introduced in the new EU Implementing Regulation 2025/1466.
We look at changes in PV audits, subcontractor responsibilities, Eudravigilance monitoring, and the end of the signal detection pilot for MAHs.
A quick, clear breakdown of what matters and what to do next.
Link: Commission Implementing Regulation (EU) 2025/1466 of 22 July 2025 amending Implementing Regulation (EU) No 520/2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and of the Council
Q&A: Questions and answers on termination of MAH EV pilot