Ready for the change? — PTI provides guidance on new EU Clinical Trial Regulation

The EU-CTR replaces the EU Clinical Trials Directive and is designed to improve harmonisation on conducting clinical trials of medicinal products for human use throughout the EU.

The EU-CTR replaces the EU Clinical Trials Directive and is designed to improve harmonisation on conducting clinical trials of medicinal products for human use throughout the EU. It brings with it significant procedural changes for both trial authorisation and conduct for which individuals and organisations must be prepared. In PTI’s webinar e-course titled ‘Guidance on the New Clinical Trial Regulation’ Adriaan Fruijtier will provide a comprehensive examination of the new regulation. He will cover the scope, authorisation procedures, low intervention clinical trials, the EU portal and database, transparency requirements, key timelines and milestones, and a helpful comparison between the new regulation and the existing directive. With over 20 years’ experience in pharma regulatory affairs, Adriaan will also be available for a valuable live question and answer session at the end of the webinar.

“This really is essential information for anyone working in clinical trials and regulatory affairs,” said PTI’s Managing Director, Rosie Bernard. “With this webinar e-course we wanted to make it as easy as possible for professionals to access the most up-to-date and useful guidance to ensure a smooth transition to the EU-CTR next year. Adriaan is an expert with a great deal of experience in pharma regulatory affairs, ranging from the European Medicines Agency to the likes of Glaxo and Novartis, so I can’t think of anyone better placed to deliver this guidance. It’s also a great opportunity for professionals to address specific queries with him personally in the live Q&A session.”