Monday, November 16 2020
How to Prepare an Effective Lifecycle Management Strategy Considering Ongoing Regulatory Changes Approval?
08.30 – 11.30
Given continually changing regulations along with the complexity of drug device combination products, this workshop will provide an opportunity to explore regulatory LCM.
This session will enable you to:
• Understand effective methods to incorporate recent regulatory changes into your LCM strategy
• Asses market conditions and continual adoptions of biosimilar
• Discover what these mean to your combination products’ commercial competitiveness
Jonathan Amaya-Hodges, Associate Director, Regulatory Affairs CMC Combination
Products & Medical Devices Biogen
Doug Mead, Principle Consultant &
President, Pathways LLC
Exploring the New Generation of Combination Products from a Quality & Regulatory Perspective
12.00 – 15.00
Discover how the combination product space continues to grow into greater complexity. Understand how you can progress into the next generation of combination products to deliver targeted patient healthcare.
Attend this session to explore:
• What the future is for combination products and how will this change the framework of modern-day medicine?
• Are there any upper limits for progression?
• What are the parameters and considerations regarding regulations and safety reporting for future generation CP?
• What resources are fundamental for progression into the next generation?
• What collaborations between drug and device will produce products which obtain market dominance?
Brette Travaglio, President & Consultant for Drug, Medical Device & Combination Product Manufacturers Quality Solutions Now
Leonel Vanegas, Device Clinical Development Quality, Alexion Pharmaceuticals
What are the Opportunities & Barriers for Digital Medicines & Devices?
15.30 – 18.30
With the advent of mobile communication platforms and wearable technologies what are the opportunities for digitizing medicines through the product lifecycle?
Join this session to analyze:
• What are the potential value propositions for digitizing medicines through the product lifecycle?
• What are the barriers, real or perceived, that would preclude the adoption of a lifecycle management strategy that incorporated a digital component?
• How will you implement this framework into your work to achieve commercial competitiveness and success
Andrew Dundon, Founder & Independent Consultant PharMechceutics Ltd