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Session 4: Developing Products for Global Distribution
Session Chair(s)
Dave Anderson
Associate Director Quality for Combination Products
AstraZeneca Biologics (MedImmune), United States
In this session, speakers will delve into topics that detail how to develop products for global distribution, including:
• European regulation of combination products: the regulatory approach, updates, and challenges
• Preparing for a multi-jurisdictional launch: Getting to market around the world, an industry perspective
• Panel discussion on priorities, challenges and goals from a regulatory and industry perspective
Speaker(s)
Europe: Drug-Device Combinations Device components of medicines
Elizabeth Baker
Medicines and Healthcare Products Regulatory Agency (MRHA), United Kingdom
Group Manager Licensing Division
Challenges of Global Combination Product Registrations
Mayank Choudhary
BD Medical - Pharmaceutical Systems, United States
Senior Regulatory Affairs Specialist, Regulatory Affairs
Device/Drug Combination Products
Paul C. Brooks
Regulatory Affairs Professionals Society (RAPS), United States
Executive Director
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