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ViewAttendees 5

Pharmaceuticals

Opportunities and Challenges with International Collaborative Initiatives

Wednesday, May 6, 2026
12:00 - 13:00 WEST
Location: Auditorium 4
Learning Level: Intermediate
Description:

• This session will outline the latest developments in international regulatory reliance and work sharing, and highlight recent innovations, to show how regulatory submissions could be streamlined and harmonised across regions.

• Second part will include the industry sponsor’s perspective on the FDA’s Project Orbis review program. It will feature illustrative case studies from Orbis submissions, highlighting practical opportunities and challenges in participation, and provide perspective on how Orbis can create opportunities for earlier regulatory approvals and patient access.

• In the final segment, a regulator perspective will offer practical insights on how industry sponsors and regulators can better leverage international collaborative pathways, while sharing the regulators’ view on current challenges and new opportunities (such as the UK-Singapore Regulatory Innovation Corridor).

Learning Objectives:

  • Explain how international collaboration models, reliance, work sharing, and new innovative pathways like the UK-Singapore Regulatory Innovation Corridor, can streamline multi-region regulatory strategies.
  • Evaluate the industry sponsor’s experience with participation in Project Orbis through illustrative case studies and articulate practical opportunities and challenges encountered during regulatory submissions.
  • Integrate regulatory perspectives and understand the regulators’ views on current challenges and emerging opportunities in international collaboration, including how reliance and work sharing can be optimised.