Date/TimeDecember 13, 2023
In today’s rapidly advancing medical device landscape, wound healing stands out as a top priority for innovation. Medical device manufacturers face many challenges in their product development and regulatory path for demonstrating the safety and effectiveness of new therapies in preclinical studies. In this webinar, NAMSA experts will offer valuable insights into regulatory considerations and testing strategies. Our speakers will provide a comprehensive overview of FDA and EU regulatory requirements, delve into testing strategies and share “tips and tricks” for navigating unconventional scenarios and novel devices.
- Regulatory Expertise: Gain in-depth knowledge of FDA and EU regulatory requirements to ensure your preclinical research and wound healing devices meet the current standards
- Testing Strategy Excellence: Discover essential testing strategies to optimize your preclinical studies for different wound healing therapies
- Navigating the Unconventional: Learn about options to consider for testing approaches when products are novel and DeNovo
Jack RisdahlPrincipal Product Development Strategist
Dr. Jack Risdahl has over 27 years of experience in medical research and in vivo laboratory medicine. He has held numerous medical research leadership positions in both academia and industry. His current responsibilities include working with sponsors to design Preclinical studies for new medical products that meet regulatory requirements worldwide.
Prior to NAMSA, he co-founded the Integra Group Preclinical Services and acted as a managing partner. He has participated in numerous FDA meetings to discuss submission requirements, preclinical study design and interpretation of results. He has also been involved with several publications, including transplantation, inflammation, immunity, infectious diseases and medical devices. Dr. Risdahl holds two doctorate degrees in Veterinary Medicine (DVM, and Ph.D.).
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.