Ms. Dominique Monferrer
Trainer
PROFILE:
Regulatory affairs professional with more than 9 years experience in development, approval and post-approval of medical devices (MDs) / in vitro diagnostics (IVDs), and pharmaceutical products (chemical drugs, biologics - biosimilars, ATMPs and herbal medicinal products). Experience based on numerous consultancy projects for pharma, biotech and medtech companies. Expert in EU regulations of MDs/IVDs of a wide technological diversity (i.e. wound-care, vascular, implant/orthopedic, substance-based and drug/device combinations, among others). Profound understanding of CE marking requirements under MDD/IVDD and MDR/IVDR legal frameworks, and of relevant regulatory guidelines and technical standards (including MEDDEV, IMDRF/GHTF and ISO/IEC/EN/ASTM/CLSI, etc.). Good knowledge of FDA regulations for MDs and IVDs. Leader of the medical devices team of the company since 2015, currently responsible for 6 direct reports.PROFESSIONAL EXPERIENCE:
- Regulatory Affairs
- Scientific Research
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Reasons to attend This interactive webinar is developed to help in vitro diagnostic medical device ...
05/05/2021