19th industry stakeholder platform - operation of European Union (EU) pharmacovigilance

• Date:
  Friday, 15 November 2024, 09:30 - 13:30 Amsterdam time (CET)
• Location:
  Online
  European Medicines Agency, Amsterdam, the Netherlands

Event summary

On 15th November, EMA will host the 19th meeting of the industry stakeholder platform on the operation of EU pharmacovigilance, which aims to inform, get feedback and foster dialogue between industry and the EU regulators. 

Topics include:
- DARWIN EU and RWE studies in medicines regulation
- PSUR updates
- Non-fixed drug combinations & pharmacovigilance
- Guidance update
- AI in PhV update
- EudraVigilance update 
- AOB: updates on Implementing Regulation (EU) No. 520/2012 and Regulation (EU) 2024/568.

The highlights and presentations from the meeting will be accessible on the corporate EMA website after the meeting.

Documents

Agenda – 19th industry stakeholder platform – operation of EU pharmacovigilance

AdoptedReference Number: EMA/499299/2024

Highlights from the 19th EMA Industry Platform meeting on the operation of EU pharmacovigilance legislation

Reference Number: EMA/538767/2024

Presentation - DARWIN EU: How is RWE transforming regulatory decision making? (A. Segec)

Presentation - Agreed approach post section 6 pilot for PSUSA ( M. Escudeiro Dos Santos, B. Pelle)

Presentation - An agency of the European Union PSUR frequencies for active substances with DLP 2025 based on a risk-based approach (M. López Fauqued)

Presentation - Revision of Guideline on Risk assessment of Medicinal Products on Human Reproduction and Lactation: from Data to Labelling (D. Duarte)

Presentation - Update on Good Pharmacovigilance Practices (EU-GVP) (P. Bahri)

Presentation - An agency of the European Union AI in pharmacovigilance – EMA update ( J. Durand, L. Pinheiro)

Presentation - EudraVigilance - Masking Policy of Personal Data (R. Postigo)

Presentation - Industry platform meeting -operation of EU pharmacovigilance (M. Rivera Vargas, P. Lopez Fernandez)