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You are here: Pharmya > All news > XEVPRM Guidance for sponsors of clinical trials

https://www.ema.europa.eu/en/documents/other/guidance-electronic-submission-information-investigational-medicinal-products-human-use-extended_en.pdf

Philippe Calandra 25 October 2021 All news
  • ← Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 October 2021
  • Electronic submission of investigational medicinal product (IMP) data to the Extended EudraVigilance medicinal product dictionary (XEVMPD) →

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

  • 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)
  • Drug clinical trials: the CTIS portal becomes the sole entry point for new requests as of the 31st of January 2023
  • Work Plan 2023 of the Pharmacovigilance Risk Assessment Committee (PRAC)
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