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
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04/06/2020 Last update