IMPs Archives - European Industrial Pharmacists Group (EIPG)

PIC/S Annual Report 2021


by Giuliana Miglierini The Annual Report of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) resumes the many activities and results achieved in 2021, despite the ongoing pandemic that required remote coordination and on-line virtual meetings. To this regard, a written procedure Read more

Joint implementation plan for the IVDR regulation


by Giuliana Miglierini Regulation (EU) 2017/746 (IVDR), establishing the new legislative framework for in vitro diagnostic medical devices (IVDs), will entry into force on 26 May 2022. The Medical Device Coordination Group (MDCG) has published an updated version of the Read more

Key issues in technical due diligences


by Giuliana Miglierini Financial due diligence is a central theme when discussing mergers and acquisitions (M&A). Not less important for the determination of the fair value of the deal and the actual possibility to integrate the businesses are technical due Read more

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

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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.