With just over five months left of the legal transition period, it is vital that sponsor companies strategically plan the transition of their ongoing EU clinical trials from the old Clinical Trials Directive (CTD) regulatory framework to the new Clinical Trials Regulation (CTR).
During this webinar, PCI’s Shawn Murtough, Director of Quality and Regulatory Services, discusses the critical timings needed to ensure a smooth transition and the implications of missing the 31st January 2025 deadline.
Shawn is joined by Tristram Evans, Vice President Global Clinical Quality and Suzanne Morgan, Associate Quality Director answering questions raised.
To prevent clinical trials losing their legal basis, advice is provided on the key documentation review and approval process alongside discussions on QP release, label changes and considerations under the new regulation.