EMA - Publication of the event’s materials of the 19th industry stakeholder platform - operation of European Union (EU) pharmacovigilance held the 15 November 2024

On 15th November, EMA will hosted 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 (E...

Publication Details

Journal
Industrias Culturais (Universidade de Coimbra)
Published
2025-02-04
DOI
https://doi.org/10.58079/138p3
Primary Topic
Pharmacovigilance and Adverse Drug Reactions
Type
article
Field-Weighted Citation Impact
0.00
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article

EMA - Publication of the event’s materials of the 19th industry stakeholder platform - operation of European Union (EU) pharmacovigilance held the 15 November 2024

Industrias Culturais (Universidade de Coimbra)
Pharmacovigilance and Adverse Drug Reactions
article

EMA - Publication of the event’s materials of the 19th industry stakeholder platform - operation of European Union (EU) pharmacovigilance held the 15 November 2024

article en

Abstract

On 15th November, EMA will hosted 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 (E...

Industrias Culturais (Universidade de Coimbra)
Partnerships for the goals
Openalex Percentile: Top 53%
Pharmacovigilance and Adverse Drug Reactions
DOIOpen Access PDFOpenAlex
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EMA - Publication of the event’s materials of the 19th industry stakeholder platform - operation of European Union (EU) pharmacovigilance held the 15 November 2024 · Industrias Culturais (Universidade de Coimbra) (2025) | TGRS Research Map | TGRS