PARIS
-15 years of experience in clinical research (Oncology, Cardiology & Spine surgery areas)
-Field: Medical devices(class II & III), pharmaceutical products (Phase 1, 2 & 3) and food
-Master degree Regulatory Affairs Medical device Lyon1 University (ongoing)
Competences
*Clinical experience
-budgets and planning
-Organize the bid defence meetings: Select the providers (CROs)
-Write the contract for experts, investigators, hospital, monitoring & biometric
-Provide input to the protocols, develop the informed consents, the case report forms and other study related documents
-Organize the Steering and DataMonitoring Committee meetings
-Organize and hold the Investigators and Monitors meetings
-Coordinate the biometric aspects (data management and statistical activities)
Regulatory experience and vigilance
-Coordinate all regulatory aspects of the projects. Manage French regulatory submissions
-Perform french regulatory submission dossiers, pharmacovigilance, materiovigilance/ pre-market activities
-Write Technical File for CE mark
-Insure the regulatory watch of the medical device and drug
-Put in place the clinical quality management system
Knowledge:
European Directive 93/42/EEC revised Directive 2007/47/CE, RECAST
Regulation 722/2012
ISO 13485, 14971, 14155, 10993, 22442, 62304 & 62366
21CFR 820, 510K & PMA
MEDDEV Guidance
ICH-GCP, European Directive 2001/20/EC revised as of April 1, 2006
