Volg deze link voor de EIPG Nieuwsbrief van januari 2022.
EIPG Webinar:IMP Manufacturing in the Era of the Clinical Trial Regulation 536/14. Thursday 18th November
IMP Manufacturing in the Era of the Clinical Trial Regulation 536/14
The next EIPG webinar will be held on Thursday 18th November. The meeting 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.
Registration information can be found in the attached flyer. You will receive connection details for the webinar when you register and please note that you need to keep this record of how to join the meeting.
The next EIPG webinar will be held on Thursday 21st October and will discuss pharmacokinetic modelling. A number of pharma companies are using platforms to predict pharmacokinetics and develop dosage forms. Our speaker, Jonathan Brown will explain how current and future applications of pharmacokinetic modelling can support the manufacturing and quality control of new products. The meeting will be chaired by Joseph O’Shea, our PIER delegate from University College Cork.
For more information, see the flyer attached.