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Strategies for Selecting the Right In Vivo Models for Regulated Preclinical Studies

About

Date/Time

Date(s) - October 28, 2020
11:00 AM - 12:00 PM

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NAMSA invites you to join us for our upcoming 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

Time will also be allotted for Q&A.

*By registering for this event, you are providing NAMSA consent to contact you directly regarding NAMSA’s services. The information you are providing will be processed by NAMSA to better understand your product needs and interests. At any time, you can submit a request to withdraw your consent for the use of information provided by you by contacting us at: communications@namsa.com. For additional information, please visit our Privacy Policy or contact us at privacy@namsa.com

NAMSA uses a third-party provider, GoToWebcast, to host NAMSA webinars. For information related to GoToWebcast’s privacy policy and utilization of information, please contact GoToWebcast directly.

Speaker

Jack Risdahl

Principal 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.).