Quality and Ethics Working Parties Workshop 2024
I Think, Therefore I Do Clinical Trials
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
Programme
| 09:30 |
Opening of the Workshop |
| 10:15 |
Welcome & 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 |
Practical implementation of Risk Management: Lessons Learned
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 Panel Discussion |
| 17:15 |
Closing Comments |
| 17:30 |
End of Day |