2nd Combination Products Lifecycle Management 2019
- Hyatt Regency Boston
- 1 Avenue de Lafayette
- United States
- View on a map
- More Information:
Lifecycle management in drug-device combination products has gained the spotlight in recent years. Drug-device developers have realized the long-term benefits of embedding an LCM mind-set at the RandD concept stage, as opposed to only applying such a program to legacy products. This will ultimately benefit our patients with faster access to better quality and more affordable therapeutics globally.
As the only industry-led community focusing on LCM, the inaugural meeting in 2018 was a huge success - gathering industry leaders from Combination Products Lead, Product Strategy and Commercial, Quality and Regulatory Affairs to share their challenges and discuss a common lifecycle framework.
The 2nd annual meeting will delve further into the trending topics by incorporating first-hand insights from the likes of Teva, Novartis AG, Allergan and Sanofi, such as: how to navigate in the unknown regulatory framework and its implications to your combination products’ launch and market access; best practices in design change control and enhancing quality validation; exploring the next innovative and commercially competitive combination products for your patients - and streamline the device development program to be the first in market.
With plenty of fresh content and experts from diverse disciplines, you will not only learn but be inspired with unparalleled stories to succeed in this space!
Speakers: Suzette Roan, Director Global Regulatory Affairs, Sanofi, Michael Roe, Director – Device Development and Industrialization, kaleo, Kristina Lauritsen, Combination Products Regulatory Advisor, FDA, Raihan Hossain, Associate Director of CH IandD Medical Device Quality, Bayer, John Schalago, Head, Global Regulatory Affairs, Devices and Applications, EMD Serono, Stephen Fournier, Director – Device Platform Management, Alnylam Pharmaceuticals, Helen Kim, Associate Director RA, Device and Combination Products, Allergan, Prasad Peri, Senior Director Regulatory Affairs CMC, Teva, Leonel Vanegas, Quality Assurance Director Medical Devices and Combination Products, Merck and Co., He Sengoku, Director, GRL Medical Devices/ Combination Products, UCB, Inc., Margaret Kelly, Device Manager Device Development and Commercialization, Novartis, Will Sutton, VP Engineering and Technology, Minnetronix Medical, Alastair Clarke, Managing Principal, Weaver Technical Solutions, Naveen Agarwal, Principal and Founder, Creative Analytics Solutions, John McMichael, Associate Director, AstraZeneca, Winifred Wu, President and Principal, Regulatory Strategy Partners, LLC, Senior Representative, Device Innovation, Eli Lilly and Company