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Product Management Service (PMS) – Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe
2022 August Aug 08

Product Management Service (PMS) – Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe

https://www.ema.europa.eu/en/human-regulatory/research-development/data-medicines-iso-idmp-standards/spor-master-data/substance-product-data-management-services

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Covid-19 Vaccine Surveillance Update – Period 17-Jun-2022 to 21-Jul-2022
2022 August Aug 05

Covid-19 Vaccine Surveillance Update – Period 17-Jun-2022 to 21-Jul-2022

https://ansm.sante.fr/actualites/point-de-situation-sur-la-surveillance-des-vaccins-contre-le-covid-19-periode-du-17-06-2022-au-21-07-2022

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The risk of myocarditis is increased but remains low after the first booster dose with an mRNA vaccine, and this risk decreases with increasing time between doses
2022 August Aug 01

The risk of myocarditis is increased but remains low after the first booster dose with an mRNA vaccine, and this risk decreases with increasing time between doses

https://ansm.sante.fr/actualites/le-risque-de-myocardite-est-augmente-mais-reste-faible-apres-la-premiere-dose-de-rappel-par-un-vaccin-a-arnm-et-ce-risque-diminue-avec-lallongement-du-delai-entre-les-doses

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EU : list of medicinal products under additional monitoring
2022 July Jul 29

EU : list of medicinal products under additional monitoring

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Oral methotrexate medicines (Imeth, Novatrex and generics): a patient card and a health professional brochure to avoid overdose
2022 July Jul 25

Oral methotrexate medicines (Imeth, Novatrex and generics): a patient card and a health professional brochure to avoid overdose

https://ansm.sante.fr/actualites/medicaments-a-base-de-methotrexate-par-voie-orale-imeth-novatrex-et-generiques-une-carte-patients-et-une-brochure-professionnels-de-sante-pour-eviter-les-surdosages

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Croatia-Minor changes to the procedure of DSUR submission
2022 July Jul 18

Croatia-Minor changes to the procedure of DSUR submission

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Belgium-FAQ_Unmet medical need_28Jun2022
2022 July Jul 15

Belgium-FAQ_Unmet medical need_28Jun2022

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Austria : Pharmacovigilance in clinical trials_23Jun2022
2022 July Jul 11

Austria : Pharmacovigilance in clinical trials_23Jun2022

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Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 July 2022
2022 July Jul 08

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 July 2022

https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-4-7-july-2022

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Meeting highlights from thePharmacovigilance Risk AssessmentCommittee (PRAC) 7-10 June 2022
2022 July Jul 04

Meeting highlights from thePharmacovigilance Risk AssessmentCommittee (PRAC) 7-10 June 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.

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

  • Product Management Service (PMS) – Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe
  • Covid-19 Vaccine Surveillance Update – Period 17-Jun-2022 to 21-Jul-2022
  • The risk of myocarditis is increased but remains low after the first booster dose with an mRNA vaccine, and this risk decreases with increasing time between doses
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