Date/TimeOctober 28, 2020
NAMSA invites you to join us for our webinar where preclinical expert Jack Risdahl (NAMSA’s Principal Product Development Strategist) will discuss strategies for selecting the best-fit in vivo models for regulated medical device preclinical studies. Highlighted during this online presentation will be considerations for choosing the right model for safety and performance testing, use and considerations for disease models and when to use cadaver and/or ex vivo models in place of in vivo studies. 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 the development continuum.
Areas to be addressed, include:
- Commonly used in vivo models for testing of medical devices
- Strategies for in vivo testing in 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
- Strategies to select the least burdensome, most scientifically sound preclinical testing pathway
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.).