This practical course will take delegates through the essential regulatory requirements for clinical research in Europe including comparisons with key US requirements. The course will also focus on the new Clinical Trial Regulation providing you with practical advice for implementation. The course will highlight the major differences between the Regulation and the Directive. There will also be additional time for delegates to discuss the implications of Brexit on regulatory affairs for clinical trials.
Live Online Training Course
Gain real-time access to a subject matter expert delivering online training in a structured virtual classroom environment.
Over this live online course students will learn through:
- Direct interaction with the trainer during live sessions
- Participation in interactive features within sessions including polls, Q&A and break out room discussion
- Pre-course reading materials, and day 1 evening reading materials
- Interaction with peers during live sessions and through the online forum
Timings and dates are subject to change - final confirmation will be provided with login details. Delegates will receive login instructions 2 working days prior to the course start date. If you have any questions please contact Katie.Condon@Informa.com
What will you learn?
EU Clinical Trial Regulation
Gain an understanding of the new EU Clinical Trial Regulation
Regulatory requirements for clinical trials
Gain a comprehensive overview of the regulatory requirements for carrying out clinical trials
Ensure compliance in regulatory requirements for investigational medicinal products, pharmacovigilance and Clinical Trial Data Management including EDC and e-source
Explore recent developments in clinical trial regulations including FDA requirements
Achieve successful regulatory inspections
Who is this course for?
This course is relevant for anyone involved in clinical trials in Europe, or liaising/supporting research professionals in pharmaceutical, biotechnology CRO/SMO companies.