The course will explain the impact of the Clinical Trial Regulation (CTR) (EU) No 536/2014 on the regulatory and assessment procedures for clinical trials in the EU with special focus on safety and pharmacovigilance. The differences between Clinical Trials Directive (CTD) 2001/20/EC and CTR EU No 536/2014 will be outlined. Participants will be able to share and discuss their first experiences with CTR/CTIS. This course will cover the rules for safety reporting, tips and tricks for submission of clinical trial application and the substantial modification, and the ASR. Typical issues and types of requests for further information will be discussed.
The course will address:
- Safety regulatory and assessment procedures under the CTD, the CTR and in a transition period.
- Brief introduction to CTIS as a main submission portal.
- Main point to consider related to CTR Q&A document.
- Regulatory expectations for a Clinical Trial Application (CTA) submission and modifications during the developmental cycle (Phase I to Phase IV) in safety documents such as Investigator’s Brochure (IB), Reference Safety Information (RSI), protocol.
- Regulatory expectations for an Annual Safety Report (ASR) submission .