NEOvations B2B Regulatory Panel: Navigating FDA Regulations

If you’re interested in learning about how medical innovations and technologies gain FDA approval, this is the event for you.

Navigating the minefield of regulatory rules, regulations, forms and filings can be a daunting task for anyone interested in bringing their novel medical device to the market. Determining the best approach is most often a self-learned activity done by trial and error or a costly endeavor if professional help is sought.

NEOvations Bench to Bedside aims to help.

We’ll be hosting a free, virtual event for interested parties with a diverse panel of regulatory experts willing to share their expertise and advice.

Our panel:

  • Rob Ngungu, the chief operating officer at Quest Medical Imaging North America. Ngungu has over 30 years of drug/device development experience leading to global registrations, approvals and post-market surveillance programs. His area of emphasis is in product development and regulatory strategies and compliance, clinical trial design, pharmacovigilance, and risk mitigation in quality systems for drugs, biologics and devices. Ngungu has also served on various Industry/FDA taskforces, delivered lectures on drug and device development topics such as “Integrated Pharmaceutical Medicine,” and “Medical Device Regulations.” Ngungu has led global development teams from small companies to large Fortune 500 companies. He started his career at Johnson and Johnson, followed by several years BMS, including VP Regulatory/Compliance and Clinical Development positions at Inamed, OraSure Technologies and Zila Biotechnology. Ngungu has a broad range of expertise across several therapeutic areas. Ngungu holds Mechanical Engineering and Applied Health Sciences degrees from London, UK.
  • Tomasz Petelenz, Ph.D., an expert at all stages of medical and drug delivery systems development from concept, funding procurement, to clinical testing, regulatory compliance and production. His specialties include medical and drug delivery device development, biomedical research, project management, regulatory compliance (medical, drug delivery devices), clinical protocols development, laboratory and clinical testing, small business start-ups. Dr. Petelenz is currently in the Department of Bioengineering at the University of Utah, where he teaches teaching medical device design courses: BioInnovate, bioDesign and bioImmersion courses at the undergraduate and graduate levels. In these courses students learn to identify and evaluate clinical needs, define products, develop and test prototype systems, develop business models and Business Plans while learning to follow the FDA Design Control process. Dr. Petelenz is also a principal and co-founder of Biomedical Innovations, a consulting company focused on assisting the medical device industry with device development, regulatory compliance, design and management of laboratory, animal and clinical studies, in all product development stages ranging from concept development, device verification, to safety and clinical efficacy demonstration.
  • George Horvath, J.D., M.D., a former practicing cardiologist and University of Akron law professor specializing in health law. His research and teaching focuses on the complex interactions between federal and state regulatory agencies, statutory and common law and their influences on health care. Further, he studies the impact of the legal system on the delivery of health care in the private and public sectors. He received his M.D. from Temple University and completed his residency in adult cardiology and cardiac electrophysiology at Northwestern University Medical Center. He earned his J.D. at the University of California, Berkeley, School of Law, where he was editor-in-chief of the California Law Review.

How to participate

This event will not only teach you about the process of regulatory approval, but also provide you with the opportunity to ask questions and make connections.

Students, trainees, faculty, staff and young entrepreneurs, we hope to see you at our event on Monday, March 20 from 7-8 p.m. Access the event.

Questions? Please contact Dr. Hope Ball, hball@neomed.edu


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