DCU is working in partnership with the European Directorate of the Quality of Medicines and Healthcare (EDQM) in Strasbourg to host an event focused on regulatory aspects of active substance manufacturing.
The event aims to provide attendees with discussion and analysis on the current “hot topics” in active substance regulation (risk management, definition of starting materials, elemental impurities, mutagenic impurities) . The theme for the Symposium is:
“Using process knowledge and Risk Management Tools to build an effective control strategy for drug substance manufacture”
The topics will be presented by regulatory experts in each relevant field from the EDQM and the HPRA.
The event itself will be chaired by Dr. Michael Morris (former HPRA / Former Chair of the European Pharmacopoeia Commission).
Further details, including the Agenda, can be found at the following link:
If you would like to find out more about the event, please do not hesitate to contact
Dr. Kieran Nolan – Head of School of Chemical Sciences DCU – 01-7005913
Ciaran Feeney – EDQM – 0033 (0)6 12 15 85 02