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EMA, new features for the PRIority Medicines (PRIME) scheme


By Giuliana Miglierini Based on the review of results obtained in the first five years of implementation of the PRIority Medicines (PRIME) scheme, the European Medicines Agency has launched a set of new features to further enhance the support to Read more

The proposals of the EU Commission for the revision of the IP legislation


By Giuliana Miglierini In parallel to the new pharmaceutical legislation, on 27 April 2023 the EU Commission issued the proposal for the new framework protecting intellectual property (IP). The reform package impacts on the pharmaceutical industry, as it contains proposals Read more

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 (16.00 BST) in conjunction with PIER and University College Cork. Sofia Trantza, a pharmacist with long experience as a Qualified Person for Pharmacovigilance Read more

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IMP manufacturing in the era of the clinical trial regulation 536/14

November 2, 2021 , , , , , ,

The next EIPG’s and PIER’s webinar to be held on Thursday 18th November 2021 (17.00 CET) will be chaired and the subject introduced by Irene Gonzales-Conde, Board Member of AEFI (Spanish Association of Industrial Pharmacists).

The main speaker, Luciano Gambini has spent most of his working life in global R&D quality assurance, setting up internal policies for the quality of Investigational Medicinal Products (IMPs). He is the coordinator of the AFI (Italian Association of Industrial Pharmacists) working group on manufacture of IMPs.

There has been extensive debate about the Clinical Trial Regulation which finally enters into force on 31st January 2022. However, little has been discussed about manufacture of the IMPs. The aim of this webinar is to raise questions and provide preliminary answers to any differences between the current and new manufacturing and labelling requirements.

This is an event for members of EIPG member organisations. Contact your national association EIPG representative for further information.