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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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Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 25-28 September 2023
2023 September Sep 29

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 25-28 September 2023

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European contact points for clinical trials
2023 September Sep 25

European contact points for clinical trials

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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 September 2023
2023 September Sep 21

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 September 2023

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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

  • European regulation on clinical trials for medicinal products: The end of the transition period
  • The ANSM publishes its haemovigilance report for 2023
  • User’s booklet – ANSM
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