Menu Back toSession 2: Trends and Updates from a Global Perspective: International Regulation of Combination Products and Opportunities for Collaboration

Combination Products Conference

Now offering a preconference Primer on October 14


Session 2: Trends and Updates from a Global Perspective: International Regulation of Combination Products and Opportunities for Collaboration

Session Chair(s)

Jonathan  Amaya-Hodges

Jonathan Amaya-Hodges

  • Senior Principal Consultant
  • Suttons Creek, Inc, 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)

Jonathan  Amaya-Hodges

Introduction to International Regulation of Combination Products

Jonathan Amaya-Hodges

  • Senior Principal Consultant
  • Suttons Creek, Inc, United States
Stephanie  Kelly, JD, MS

Industry Perspectives on Challenges and Opportunities in Global Regulation of Combination Products

Stephanie Kelly, JD, MS

  • Director, Global Head Regulatory Intelligence and Policy
  • Kyowa Kirin, United States
Tim  Chesworth

Industry Perspectives on Challenges and Opportunities in Global Regulation of Combination Products

Tim Chesworth

  • Senior Director Regulatory Affairs
  • AstraZeneca, United Kingdom
Manfred  Maeder, PhD

Progress of the ASTM Global Standard for Combination Products

Manfred Maeder, PhD

  • Head of Device Development & Commercialization
  • Novartis, Switzerland