Site audit preparation and French/International Regulations/Directives update
Optimarc members were recently trained on the following topics:
- Site audit
- French and International Regulations/Directives updates
The trainer focused the presentation on the following topics:
- How to get the site « Audit Ready »
- How to schedule the audit at the investigator’s site
- Lessons learned from previous Inspection – Audit – Quality Check Visits
- Update on Laws / Main differences between French and European Directives
- Clinical Trial Initial Application Package to be submitted to both Central Ethics Committee and Comptetent Authority (ANSM -French Drug Agency)
- Consequences and actions to implement related to GDPR and French CNIL (National Council for Data Protection) – Methodology to comply with for Regulatory Submission
- Refresher on « Jardé Law », anticorruption measures to consider in clinical trials
