Date/TimeDate(s) - March 16, 2023
12:00 AM - 12:00 AM
Boulevard Auguste Reyers, 80
NAMSA invites you to join us at Medtech Meetup on March 16 in Brussels, Belgium. MedTech Meetup is a unique event in Belgium that sheds light on the Belgian industry of medical devices, IVD medical devices and Digital Health. Don’t miss this great opportunity of learning from experts in the field, meeting peers and discovering promising medtech innovations.
Don’t miss Gaelle Clermont’s session “Strategies for selecting the best preclinical models for regulated medical device studies” at 2p in Einstein C Room. Highlighted during this presentation will be considerations for choosing the right model for compliant safety and performance testing as well as study design considerations and possible pitfalls. In addition, we will examine how medical device sponsors can strategically plan and leverage preclinical studies to build efficiency into regulatory submissions to save time and money throughout device development.
Topics to be addressed will include:
- Commonly used in vivo models for testing of medical devices
- Strategies for regulated medical device preclinical studies
- When to consider alternative models such as ex vivo or cadaver models to support study endpoints
- How to avoid common mistakes when developing in vivo studies
- How to use FDA pre-submissions
NAMSA is the world’s leading MedTech CRO offering global end-to-end development services. Driven by our regulatory expertise and in-depth therapeutic knowledge, NAMSA has assisted thousands of MedTech Sponsors make a positive impact to healthcare since 1967. Today, our team of global Associates delivers market-leading Contract Research Organization (CRO) services to Clients in all major markets of the world. NAMSA provides unparalleled medical device testing capabilities, strategic guidance and tactical support to fast-track market introduction and commercialization. From concept to post-market, we are proud to fully support Clients through the delivery of exceptional outcomes throughout every stage of the MedTech development continuum.
Gaelle ClermontSenior Product Development Strategist
Gaelle has over 20 years’ experience within the medical device industry, and has directed numerous preclinical studies in many fields, most notably cardiology, orthopedics, gastroenterology, dental, wound healing, general surgery, and drug delivery. Gaëlle has supported the development and regulatory approval of various devices, combination products and new biotechnologies through preclinical safety, performance and efficacy evaluations. She is an industry-leading expert in assisting global device manufacturers to accelerate clinical research and regulatory approval of innovative medical technologies.
Gaëlle holds a Doctorate in Pharmaceutical Sciences Degree and PhD in Cardiovascular Pharmacology from the University of Burgundy (France). She also earned a Medical Device and Biological Products Regulation Degree from the University of Paris.