Compliance Pitfalls of In Vivo Studies—How to Learn from the Mistakes of Others

In our sixth episode of the NAMSA RAQA Café Podcast, we sit down with guest speaker Jack Risdahl, NAMSA Principal Product Development Strategist and Doctor of Veterinary Medicine.

During our discussion, Jack delves into common mistakes that are observed when conducting In Vivo studies, ways in which to mitigate these mistakes and variances pertaining to In Vivo study expectations in different global markets.

“We reach out to other experts and bounce ideas. Am I missing something based on your experience?” – Jack Risdahl (Principle Product Development Strategist)

Discussion topics include:

• Institutional Animal Care and Use Committee (IACUC) and how a small company can navigate animal welfare requirements
• How to engage with a cross-functional team to rectify mistakes
• Study considerations and best practice for evaluations

Helpful Links:

• Animal Testing: Why the FDA Is Exploring More Alternatives (healthline.com)
• FDA no longer needs to require animal tests before human drug trials (science.org)

Meet the Speakers

Jack Risdahl, DVM, PhD; Principal Product Development Strategist, NAMSA

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.).

Linford Leitch; Regulatory Consultant, NAMSA

In 2021, Linford joined NAMSA as a Regulatory Consultant. He has 9 years of experience in the medical device industry with direct regulatory experience with Spine, Transcatheter Heart Valves and Hemodialysis devices. He specializes in developing global regulatory strategies for entry to market and maintain strategies throughout product lifecycle.

Richard Granquist; Senior Quality System Consultant, NAMSA

Rich Granquist has 17 years of experience in the medical device industry and has spent extensive time working with both start-up manufacturers and larger, global device manufacturers. He specializes in quality system development and risk management.

Rich started in the medical device industry as a Microbiologist focusing on preclinical testing including, packaging validation, biocompatibility testing and reprocessing instruction validation for urology and women’s health devices. He spent several years as a Quality Engineer performing complaint investigations, root cause investigation and product development focusing on aortic intervention vascular devices. In 2014, Rich joined NAMSA as a Quality Systems Consultant. Over his 16 years in the medical device industry, he has participated in numerous AAMI ISO standards committees and currently sits on the AAMI working groups for AAMI ISO 14971, AAMI ISO/TR24971, AAMI ISO 13485 and AAMI ISO 15223.