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The European Medicines Agency (EMA) is delivering a Product Management Service (PMS) and a Substance Management Service (SMS) to support regulatory activities in the European Union (EU)
2023 February Feb 06

The European Medicines Agency (EMA) is delivering a Product Management Service (PMS) and a Substance Management Service (SMS) to support regulatory activities in the European Union (EU)

https://www.ema.europa.eu/en/human-regulatory/research-development/data-medicines-iso-idmp-standards/spor-master-data/substance-product-data-management-services?fbclid=IwAR2n_D1C_FF0oRphglmchOODcHaeMU-9JxVlSRp4FrBuuBLdSePYAl-Utd8

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Drug clinical trials: the CTIS portal becomes the sole entry point for new requests as of the 31st of January 2023
2023 February Feb 02

Drug clinical trials: the CTIS portal becomes the sole entry point for new requests as of the 31st of January 2023

https://ansm.sante.fr/actualites/essais-cliniques-medicaments-le-portail-ctis-devient-lunique-point-dentree-pour-les-nouvelles-demandes-au-31-janvier-2023?fbclid=IwAR1Iw2CrNskojkz-AQ-WTsgdS4DE4LkvlQShsXdm2jXeFdrvQ_RwUGvWJoc

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Work Plan 2023 of the Pharmacovigilance Risk Assessment Committee (PRAC)
2023 January Jan 30

Work Plan 2023 of the Pharmacovigilance Risk Assessment Committee (PRAC)

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Welcome to the team!
2023 January Jan 25

Welcome to the team!

The Pharmya team is growing! Welcome Ryan, the new team assistant!

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Shortages of antibiotics affecting the EU are a public health concern
2023 January Jan 24

Shortages of antibiotics affecting the EU are a public health concern

https://www.ema.europa.eu/en/news/joint-statement-executive-steering-group-shortages-safety-medicinal-products-mssg-shortages

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10 Years !
2023 January Jan 09

10 Years !

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PRAC recommendations-signals adopted
2023 January Jan 06

PRAC recommendations-signals adopted

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2023 January Jan 03

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Italy : AIFA OPERATING PROCEDURE for local pharmacovigilance managers : Management of reports in the national pharmacovigilance network
2023 January Jan 02

Italy : AIFA OPERATING PROCEDURE for local pharmacovigilance managers : Management of reports in the national pharmacovigilance network

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Monitoring of adverse drug reactions in the management of Covid-19 as of 8-Dec-2022
2022 December Dec 30

Monitoring of adverse drug reactions in the management of Covid-19 as of 8-Dec-2022

https://ansm.sante.fr/actualites/suivi-des-effets-indesirables-des-medicaments-utilises-dans-la-prise-en-charge-du-covid-19-en-date-du-8-12-2022

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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

  • FAQs: Introduction to the Clinical Trials Regulation (EU) No 536/2014 – CTIS Training Programme – Module 01
  • Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10-13 February 2025
  • CHARGE(E) DE PHARMACOVIGILANCE HYBRIDE
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