This webinar covers regulatory pathways for drugs, devices, and combination products. Dr. Lamson provides his insights on the 505(b)(2) pathway for new drugs while Ms. Benokraitis discusses a variety of regulatory pathways for devices, including 510(k), Premarket Approval (PMA), and De Novo. The presentation concludes with a discussion of how these various regulatory pathways intersect for drug-device combination products.
At the end of this webinar, attendees should have a better understanding of:
- How to use the 505(b)(2) pathway to streamline drug development effectively
- Which device regulatory pathway is appropriate for your standalone device or combination product
- The interplay of drug and device pathways for developing combination products
Meet the Presenters
Michael J. Lamson, Ph.D.
Vice President, Clinical Pharmacology & Pharmacokinetics | Nuventra
Dr. Lamson has over 28 years of experience in pharmacokinetics and clinical pharmacology. Dr. Lamson’s strategic regulatory experience includes product development for NDAs, sNDAs, ANDAs, and 505(b)(2) NDAs. His skills also include using innovative analytical methods, such as modeling and simulation, to evaluate PK disposition and in vivo drug delivery performance throughout drug development.
Director of Quality & Operations | Gilero
Ms. Benokraitis has over 17 years of experience working with medical and drug delivery devices. She began working at Gilero in 2007 as a Quality Engineer and became the Director of Quality and Operations in 2011. Kristin is the company’s regulatory subject matter expert, having authored multiple regulatory submissions. In addition, she has managed countless projects developing medical devices and combination products for a variety of clinical applications.