Monday, Nov 16, 2020 8:00a -
Wednesday, Nov 18, 2020 5:00p
The Westin Boston Waterfront
425 Summer Street
Boston, MA 02210
$Conference + 3 Workshops: USD 3996.0, Conference + 2 Workshops: USD 3597.0, Conferece + 1 Workshop: USD 3098.0, Conference Only: USD 2499.0, Workshop(s) Only: USD 699.0
Lectures & Conferences
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 And 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 And Combination Products, Sanofi, Gabriel Iobbi, Device Portfolio Group Head, Novartis, Amy Wang, Director of Drug Delivery And Device Development, Alexion, Jonathan Amaya- Hodges, Associate Director, Regulatory Affairs CMC Combination Products And Medical Devices, Biogen, Doug Mead, Principle Consultant And President, CP Pathways LLC, Brette Travaglio, President And Consultant for Drug, Medical Device And Combination Product Manufacturers, Quality Solutions Now, Raihan Hossain, Risk Lead, Device Engineering Lifecycle Management, Pfizer, Andrew Dundon, Founder/Independent Consultant, Pharmechceutics Ltd