EU Clinical Trial Regulation: Managing Your Trials Through Transition and Beyond
We are delighted to invite you to Almac’s upcoming live webinar, EU Clinical Trial Regulation: Managing your Trials Through Transition and Beyond, which will take place on Wednesday 25th May 2022 at 3PM BST.
The new Regulation is fully applicable, Clinical Trials Information System (CTIS) is live, and the EU is progressing quickly through the first of two transition periods from the Clinical Trial Directive to the new Regulation. Sponsors must assess their existing and upcoming trials and consider their plans for transition to the Regulation. Under the new Regulation, there are several changes that impact the packaging and distribution of clinical supplies. However, the most impactful change is the Annex VI requirement for the expiry date to appear on all clinical labels, with no option to omit the expiry date from the primary container.
Throughout this live webinar, Almac experts will discuss how they can support with the transition of your trial from the Directive to the Regulation and provide solutions on how to manage the expiry date requirement of the new Regulation.
Key Learning Objectives
The transitional timelines under the EU Clinical Trial Regulation (CTR)
Learn more about how Almac can support with transitioning trials
Packaging and supply chain solutions for expiry date management
Just in Time Manufacturing solution for the management of EU clinical supplies
