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Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 23-26 October 2023
2023 November Nov 02

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 23-26 October 2023

https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-23-26-october-2023

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Minutes of the Pharmacovigilance Risk Assessment Committee (PRAC) meeting of 28-31 August 2023
2023 October Oct 30

Minutes of the Pharmacovigilance Risk Assessment Committee (PRAC) meeting of 28-31 August 2023

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Early access to medicines: a positive assessment after two years of implementation
2023 October Oct 27

Early access to medicines: a positive assessment after two years of implementation

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Benefit-Risk Assessment for New Drug and Biological Products – Guidance for Industry
2023 October Oct 23

Benefit-Risk Assessment for New Drug and Biological Products – Guidance for Industry

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EMA – Mid-year report 2023
2023 October Oct 20

EMA – Mid-year report 2023

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ANSM – Summary of the 2022 Activity Report
2023 October Oct 16

ANSM – Summary of the 2022 Activity Report

https://ansm.sante.fr/syntheseRA2022FR/index.html#page/1

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Feedback on the October 2023 PRAC (25 – 28 September)
2023 October Oct 13

Feedback on the October 2023 PRAC (25 – 28 September)

https://ansm.sante.fr/actualites/retour-dinformation-sur-le-prac-doctobre-2023-25-28-septembre

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Minutes of the Pharmacovigilance Risk Assessment Committee (PRAC) meeting on 03-06 July 2023
2023 October Oct 09

Minutes of the Pharmacovigilance Risk Assessment Committee (PRAC) meeting on 03-06 July 2023

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Regulation on Clinical Trials (EU) N°536/2014 Questions and Answers
2023 October Oct 06

Regulation on Clinical Trials (EU) N°536/2014 Questions and Answers

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EMA – Risk management plans – Update
2023 October Oct 02

EMA – Risk management plans – Update

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Pharmya – Pharmacovigilance

PHARMYA is a French based company, dedicated to providing Pharmacovigilance services. Its mission is to support the pharmaceutical industry, biotechnology companies, research centers and their service providers in their efforts to comply with international Pharmacovigilance regulations.

In partnership with the region

Contact

  • PHARMYA
  • 315 Av. Saint Sauveur du Pin
  • 34980 Saint Clément de Rivière (Montpellier), France
  • Phone: +33 411 93 21 10
  • Email: info@pharmya.com
  • Website: www.pharmya.com

News

  • Relaunched EMA website now live
  • Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 27-30 November 2023
  • ANSM publishes the 2022 haemovigilance activity report
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