Irene Gonzales-Conde Archives - European Industrial Pharmacists Group (EIPG)

Steps forward towards the new framework for HTA


By Giuliana Miglierini The long-waited European regulation on Health Technology Assessment (HTA) was adopted by the Council of Europe on November 9, and it has now to pass through the final endorsement of the European Parliament as the last step Read more

Commission establishes portfolio of 10 most promising treatments for Covid-19


by Giuliana Miglierini The second phase in the development of new medicines to treat Covid-19 - a part of the EU Strategy on Covid-19 Therapeutics launched in May 2021 - has reached a cornerstone with the announcement made by the Read more

A new role for EMA and a pilot project for the repurposing of medicines


by Giuliana Miglierini A draft agreement was reached at the end of October between the Council of the European Union and the European Parliament to reinforce the mandate of the European Medicines Agency (EMA) with reference to crisis preparedness and 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.