MODULE 1: Safety in clinical trials under the CTR
- Introduction
- Changes of regulatory and assessment procedures under the CTR: Clinical Trial Information System (CTIS)
- Safety reporting in clinical trials
- Breakout sessions and discussion: Hot topic and new challenges related to the CTR
MODULE 2: The Reference Safety Information (RSI)
- 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
- Focus on the CTR Q&A document: frequent issues and tips and tricks to avoid them
- Breakout sessions, group exercise and discussion: Focus on RSI
MODULE 3: The Annual Safety Report (ASR)
- ASR submission, assessment and regulatory expectations
- ASR writing: format and requirements
- Breakout sessions, group exercise and discussion: How to plan and write your ASR
Professionals involved in the planning, preparation and review of the documents related to clinical trial applications and/or substantial modifications including documents such as Investigator’s Brochures, protocols, Annual Safety Reports, etc.
Professionals who are actively involved in preparation of their organizations to the CTR (EU) No 536/2014 or whose working procedures will be impacted by it.
In particular: Drug Safety and Pharmacovigilance department, Regulatory Affairs department and Quality and Compliance department (e.g. medical writers, pharmacovigilance writers, pharmacovigilance officers, pharmacovigilance managers, QPPVs, safety physicians, managers regulatory affairs and medical evaluators/advisors, document quality and compliance managers).
Participant Experience
Basic knowledge of drug development, safety and/or pharmacovigilance.
Presentation, hands-on exercises using real life anonymized cases, group discussions with a limited number of attendees.
