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Session 2: Trends and Updates from a Global Perspective: International Regulation of Combination Products and Opportunities for Collaboration
Session Chair(s)
Jonathan Amaya-Hodges
Senior Principal Consultant
United States
Regulations specific to combination products have now expanded well beyond the United States and European Economic Area (EU), as other key global regions market their own frameworks for such products. While some regulatory schemes closely follow those established by the US or EU, some take new approaches and warrant additional attention. Ultimately, sponsors must navigate a variety of requirements to place their combination products on the market globally, while regulatory authorities will face the growing need for harmonization in this area.
Learning Objective : At the conclusion of this session, participants should be able to:
- Describe the current state of the global regulation of combination products
- Recognize challenges from divergent regulations concerning such products and opportunities for convergence
- Apply future opportunities for harmonization and how stakeholders can facilitate
Speaker(s)
Introduction to International Regulation of Combination Products
Jonathan Amaya-Hodges
United States
Senior Principal Consultant
Industry Perspectives on Challenges and Opportunities in Global Regulation of Combination Products
Stephanie Kelly, JD, MS
Kyowa Kirin Co., Ltd., United States
Global Head Regulatory Intelligence and Policy
Industry Perspectives on Challenges and Opportunities in Global Regulation of Combination Products
Tim Chesworth
AstraZeneca, United Kingdom
Senior Director Regulatory Affairs
Progress of the ASTM Global Standard for Combination Products
Manfred Maeder, PhD
Novartis, Switzerland
Head of Device Development & Commercialization
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