2nd Combination Products Lifecycle Management 2019 (description)


Category:Health & Wellness
Address:1 Avenue de Lafayette, Boston, Massachusetts, United States of America 02111
Phone:+1 617 455 4188
Event dates:6/25/2019 - 6/27/2019
Event web site:
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Topics to be Covered:

  • 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
  • Conferences
  • Science
  • Health and Medicine
  • Pharmaceuticals
  • Drug Development
  • Regulatory Affairs
Organizer phone:+1 617 455 4188
Offering type:Conference
Specialty:Data not provided
Event frequency:Never
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Total events:
Est. attendance:
Target audience:Any
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Host Sponsor:Hanson Wade
Est. # of exhibitors:
Currency:US Dollars
Language:Data not provided
CE Credits:
Organizer URL


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!


8:30 am - 3:00 pm

Registration Fee Details:

Conference + 3 Workshops: USD 3996.0,
Conference + 2 Workshops: USD 3597.0,
Conference + 1 Workshop: USD 2499.0,
Conference Only: USD 2299.0,
Workshop Only: USD 699.0

Other items that tuition includes:

Travel and hotel arrangements:

Contact Person:Sophie Ellis
Organizer State/Province: (Outside US)
Organizer CountryData not provided
Organizer Phone+1 617 455 4188
Structural makeupData not provided
Host Sponsor; Other SponsorsHanson Wade
Event Site/VenueHyatt Regency Boston
Event sold out?No
Multiple locations or dates?No
Statistics available for most recent event held in:NA
Average number in event attendance of:
Number in attendance of:
Target BoundariesInternational
Is Registration contact information the same as Organizer Contact above?NA
Registration Contact:
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Web Page
Can one register for your CE on your web site?NA
Can registration be made by snail (regular) mail?NA
Online housing reservations: 
Do you have additional written or AV materials for sale?No
If so, are they available for non-attendees as well as those attending?NA
Is full tuition necessary to ensure registration?No
Will there be shuttle service available?NA
Additional notes:


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