Introduction to the new Clinical Trial RegulationVan Derden
Introduction to the new Clinical Trial Regulation
Thursday, September 15, 2022 | 11:00am – 12:00pm ET | 5:00pm – 6:00pm CET
Presented by Rosie Ackerman-Johnson
The new Clinical Trial Regulation (CTR) went live on 31st January 2022 bringing with it significant changes to how clinical trials are submitted and run in Europe.
We are currently in the transition period where the Sponsor can choose whether to submit their clinical trial through the old Clinical Trial Directive (CTD) or under the new regulation. However, the end of the transition period in January 2023 is fast approaching and more sponsors are now considering initiating their clinical trial applications under the CTR.
Join our Insider Talk to get up to speed with the CTR as we go through the new concepts, differences between the CTD and CTR, introduce the Clinical Trial Information System (CTIS), and provide guidance on submitting under the regulation.
Interested in learning more? Register today and join us for a live webinar, free of charge.
Learning objectives of this Complimentary Live Webinar:
- Quick recap of the current landscape under the CTD
- Introduction to the CTR
- Outline some differences between the CTD and CTR
- Introduction to CTIS
- Regulatory submissions under the CTR
About Insider Talks
An open forum where ProPharma Group’s scientific and technical experts share their insights on timely topics in our industry. Pharmaceutical, biotechnology, and medical device and diagnostic companies gain new ideas and perspectives to help tackle complex challenges and deliver on our higher purpose of improving the health and safety of patients.