Throughout this webinar David will share his knowledge and experience of various EU regulatory filing options focusing primarily on the Centralised Procedure.
David will highlight the criteria an applicant must meet, the key information required for submission and identify critical time points throughout the Centralised Procedure process.
Now that the UK has withdrawn from the EU, David will also share insight into the impact of Brexit on Regulatory Strategies. He will provide guidance and share vital information on the best approach for you to gain approval in the UK post a positive CHMP opinion and EC decision.
This webinar will help you navigate the various EU & UK regulatory filing options to allow you to plan ahead and save time in what can be a lengthy and complicated process.
Tuesday 1st June, 3pm BST
Speaker: David McCoubrey, Regulatory Affairs Lead
Regulatory Affairs Lead
David has worked in the Scientific Affairs Department of Almac Group for over ten years. His experience encompasses development, pre-approval and post-approval regulatory activities. This includes the management of scientific advice meetings, compilation and submission of clinical trial applications, and the management, compilation and submission of new Marketing Authorisation applications for medicinal products in the EU. David also has experience with the maintenance of INDs and NDAs for US drug products. He has prepared, submitted and maintained EU and US orphan designations, including managing pre-submission teleconferences with the European Medicines Agency and FDA.
After graduating from Queen’s University Belfast with a Masters degree in Pharmacy, David completed his training as a Pharmacist with Alliance Boots. He worked as a Pharmacist Manager for the company for three years before joining Almac.