Webinar: Pharmacovigilance as a specialization and the role of the Pharmacovigilance Risk Assessment Committee (PRAC)
EIPG webinar Next EIPG webinar is to be held on Wednesday 31st of May 2023 at 17.00 CEST…
EMA’s new Quality Innovation Expert Group (QIG)
by Giuliana Miglierini Innovative approaches to the development manufacturing and quality control of medicines are becoming the new…
A new joint work plan to 2023 for EMA and EUnetHTA 21
by Giuliana Miglierini The new Regulation (EU) 2021/228 on Health Technology Assessment (HTA) will assume full validity in…
Revision of the PIC/S GMP Guide: Annex 13 and Annex 16
by Giuliana Miglierini The entry into force of EU Regulation 536/2014 “Clinical trials”, at the end of January,…
The new guideline on combination products between medicines and medical devices
by Giuliana Miglierini The new “Guideline on quality documentation for medicinal products when used with a medical device”…