Description
Are you confident your preclinical animal study meets FDA expectations? Preclinical animal studies are a pivotal part of medical device development, but navigating FDA requirements can be complex. In this webinar, we’ll demystify the regulatory expectations and help you design studies that meet both safety and performance standards. Whether you’re new to preclinical research or refining your approach, this session will provide actionable insights to help you move confidently toward approval.
Key Learning Objectives:
- The FDA’s key requirements for preclinical animal studies.
- How to design studies that align with regulatory expectations.
- Best practices to avoid common pitfalls
Speakers
Principal Strategy Consultant, Preclinical
Dr. Gaelle Clermont has over 20 years of experience in medical product development and testing, specifically in these therapeutic areas: cardiovascular, orthopedics, wound healing and general surgery, among others. Dr. Clermont has both Doctor of Pharmaceutical Sciences (Pharm.D.) and Doctor of Philosophy (Ph.D.) degrees, and began her career at a University Hospital before joining NAMSA in 2001. During her career at NAMSA, she has progressed from Study Director, Laboratory Scientific Director and now to her current role as Preclinical Specialist within the Global Strategy group. Her expertise in preclinical studies and safety evaluations allows her to work with innovative medical device companies supporting their development and regulatory strategies, looking to accelerate the development of their technology and to also address regulatory agency expectations and responses to those studies.
Principal Strategy Consultant, Preclinical
Dr. Jack Risdahl has over 30 years of experience in medical product development and testing. Dr. Risdahl has both Doctor of Veterinary Medicine (DVM) and Doctor of Philosophy (Ph.D.) degrees, and began his career in academia at the Medical and Veterinary Schools at the University of Minnesota. Following, he served in a Global Director role at Baxter while also holding a faculty position at the Mayo Clinic.
Prior to joining NAMSA in 2012 through acquisition, Dr. Risdahl was an entrepreneur, co-owner and managing partner of the Integra Group. While at NAMSA, Jack was the Director of Preclinical and Functional Studies with global oversite before joining the Global Strategy Consulting Group in 2017. His expertise in preclinical studies and safety evaluations allows him to work with innovative medical device companies looking to accelerate the development of their technology, and to also address regulatory agency expectations and responses to those studies. As a former entrepreneur, he is also able to understand and assist in product development strategies for accelerating product development testing that meet specific business goals. He has a broad experience across the medical device spectrum of products for devices, biologics and combination products including but not limited to regenerative medicine, cell therapy and transplantation, neurostimulation and cardiovascular devices.
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This is a free educational webinar.
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