Lee Leichter has over 40 years experience, providing hands-on assistance to domestic and international Pharmaceutical, Biotechnology and Medical Device companies for the last 20 years. Projects have encompassed business, technical, regulatory and quality issues, mostly relating to drug delivery and combination products for marketing in the USA, Europe and Canada. He has worked with large multi-national companies and start-ups successfully navigating the challenges posed during the development, testing and marketing approval of products that merge drugs with device systems.
He serves as an independent expert on AAMI and ISO technical committees for Injection and respiratory products, infusion pumps, needles and catheters, and Human Factors committees, helping establish international standards for safety and performance of these products. He initiated, and leads the ISO Workgroup developing a standard for Bolus injectors. He has directly proposed and responded to FDA positions and proposals covering combination products, most recently as a consultant to the Combination Products Coalition. He is also the Chairman of the PDA Combination Product Interest Group.
He has helped organized and chaired several conferences dedicated to Combination products and Human Factors and has trained and presented on a multitude of topics over the last 20 years.and EU Regulatory Affairs from RAPS.