Quality and Ethics Working Parties Workshop 2024

I Think, Therefore I Do Clinical Trials


Event Workshop
Type Face To Face
Language English
Date(s) 1 July 2024
Day(s) 1 Day(s)
Duration 8 Hours

Who We Are:
EFGCP is the European Forum for Good Clinical Practice, we are a not-for-profit organisation established by, and for, individuals with a professional involvement in making medicines and medical devices available to patients. The Quality & Ethics Working Parties meet three to four times a year to share quality, compliance and ethical perspectives on Clinical Trials, Clinical Research and Patient Safety.

I Think, Therefore I Do Clinical Trials - Overview:
This interactive, practical workshop will feature a range of speakers on topics including the revision of ICH GCP (ICH GCP Guideline E6 Revision 3), Trial Oversight, Risk-Based Trial Master Files, and Complex Clinical Trial Audits. 

Who Should Attend?
Anyone with an interest in current and future clinical trials. Commercial and non-commercial clinical trial researchers. Quality Assurance and Compliance Professionals. GCP Auditors. Trial Co-ordinators. Project Managers. Clinical Study Monitors. Clinical Research Associates. Pharmacy Specialists and/or Clinical Trial Technicians. Ethics Committee Representatives. Regulatory Affairs Representatives. Principal and Co-Investigators.

With the Support of



09:30 Opening of the Workshop
10:15 Workshop & Introduction
Louise Mawer, Mirabilitas Ltd
Sophie Morin, Forward Quality Solutions Ltd
10:30 ICH GCP E6(R3)
Mary Kearns, Senior Director Quality Assurance, Merck Sharp & Dohme Corp.
11:15 Quality by Design & Risk Assessment Relationships
Filip Raps, Head Global Quality Risk Management, Galapagos
11:45 Keep it Simple – Audits of Complex Clinical Trials
Sophie Morin, Forward Quality Solutions Ltd
12:15 Lunch
13:00 Trial Oversight – Serious Breaches
Mihaescu Camelia, European Medicines Agency
13:30 Ethical Considerations
Heather Sampson, University of Toronto, Canadian Blood Services
Hugh Davies, UK Health Research Authority
14:00 Risk-based Trial Master Files
Louise Mawer, Mirabilitas Ltd
14:30 Workshop: Risk-based Oversight Activities
15:30 Workshop Feedback
16:30 End of Day Discussion
17:15 Closing Comments
17:30 End of Day