3rd Lifecycle Management for Combination Products Summit

The 3rd Lifecycle Management for Combination Products Summit is the only peer-led community that is bringing over 100+ senior leaders from drug-device teams including regulatory affairs, product development and quality together to share key opinions on how to maximize your combination products’ lifespan and how to continue to deliver a quality drug-device product for your patients.

Join the community to explore and discuss:

How to handle and navigate the evolving regulatory landscape, especially EU MDR’s commercial implications on combination products in Japan and APAC

Design control and quality – how to collaborate with multiple teams for full oversight of LCM

When should you start an LCM initiative? Challenges with drug-device products

Assessing next gen combination products opportunities to extend your product lifespan

Lifecycle management for drug-device combination products has stolen the spotlight amongst pharma, biotechs and device developers. That said, effectively integrating multiple project teams and defining a common LCM program can be challenging – but if you join us in June you will be given unparalleled access to key experts who can guide you on how to implement a robust LCM program to reap the significant benefits from the get-go.

Speakers: Khaudeja Bano, Head of Medical Affairs, Abbott Diagnostics, Andrew Yum, Director of Medical Device Development, United Therapeutics, Susan Neadle, Senior Director, Global Quality Design, Johnson & Johnson, Kirsten Paulson, Senior Director, Global CMC Medical Device Lead, Pfizer, Chandra Ma Senior Manager, Global Regulatory Affairs CMC, Device and Biosimilars, Amgen, Karthik Balasubramanian, Associate Director, Global Device R&D, Teva, Paul Chao, Associate Director, Combination Product Development, Regeneron Pharmaceuticals, John Weiner, Associate Director, Office of Combination Products, FDA, H.E. Sengoku, Director, GRL Medical Devices/ Combination Products, UCB, Inc., John McMichael, Associate Director, Combination Products, AstraZeneca, Dana Korkuch, Head of Quality Device & Combination Products, Sanofi, Gabriel Iobbi, Device Portfolio Group Head, Novartis, Amy Wang, Director of Drug Delivery & Device Development, Alexion, Jonathan Amaya- Hodges, Associate Director, Regulatory Affairs CMC Combination Products & Medical Devices, Biogen, Doug Mead, Principle Consultant & President, CP Pathways LLC, Brette Travaglio, President & Consultant for Drug, Medical Device & Combination Product Manufacturers, Quality Solutions Now, Raihan Hossain, Risk Lead, Device Engineering Lifecycle Management, Pfizer, Andrew Dundon, Founder/Independent Consultant, Pharmechceutics Ltd

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Brochure https://go.evvnt.com/592209-3?pid=6581 Time: 8:00 am - 5:00 pm