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