045 - "Combination Products around the Globe" with Susan Neadle

On this episode, we were joined again by Susan Neadle! This episode was focused on the current state of Combination Products globally. Susan and I discuss: - CPC Summit and Updates from FDA - Essential Performance Requirements(EPR's) - ASTM Harmonization for an International Combination Products Terminology Standard -Different Approaches to Combination Products Globally : US, EU, UK, Canada, Japan, China, Australia, and Saudi Arabia -Upcoming Combination Products Conferences in Q4 Susan Neadle, MS, BS, FAAO is a recognized international Combination Products and Medical Device expert with over 35 years of industry experience. She is Principal Consultant and President of Combination Products Consulting Services LLC, applying her extensive leadership and technical skills and experience to provide hands-on design-to-value, program management, quality & compliance, and regulatory consulting services, for pharmaceutical, biotech and medical device industries. Among her many significant industry affiliations and contributions, she serves as Chair of the ISPE Combination Products CoP, lead author on the ASTM International Combination Products Standard Committee. Most recently, Susan served as Head of Combination Products, Medical Devices, Digital Health & IVD Regulatory Affairs at Amgen, providing strategic leadership in global combination products/ device regulatory development. Susan retired from Johnson & Johnson. Her distinguished career there of more than 25 years included integral leadership roles in R&D, Quality Engineering, Design-to-Value, Risk Management and Quality Systems, spanning pharmaceuticals, medical devices, and consumer health. She led the team that defined and successfully implemented the globally integrated business model to meet Combination Products regulations for Janssen.