The EU New Clinical Trial Regulation (EU) No 536/2014 – Basics and Implementation
12 Contact Hours - 3 Days
Overview The new EU Regulation (EU No 536/2014) replaces the previous EU Directives (2001/20/EC, 2003/94/EC and 2005/28/EC), with many changes. This has led to confusion from sponsors, Contract Research Organizations (CROs), and sites. This training will provide the attendees with an understanding of the new processes and requirements for EU sponsors of clinical trials as the new regulation implemented by the Member States, the European Medicines Agency and the European Commission.
Objectives
Objectives
At the end of the training, participants will:
- Understand the objectives of the EU Regulation and why it is replacing the EU Directive
- Understand the new required process for trial registration
- Understand the new required procedures for submission and revision of the Clinical Trial Application (CTA)
- Learn the changes in GMP and GCP as per the new regulation