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Clinical Trial Events
BIO-Europe 2026

Panel Clinical Strategy track

Unlocking APACs Clinical Trials Potential: Navigating Regulatory Pathways, Bridging Strategies and Market Access Across the Region

Tue, Nov 10, 2026 · 1:00–1:55 PM CET Clinical Strategy Stage, Koelnmesse

About this session

Examine cost-benefit frameworks for bridging studies across Japan, Korea, Taiwan and ASEAN countries, balancing regulatory requirements, ethnic sensitivity considerations and commercial ROI to accelerate regional approvals Explore the unique regulatory pathways and requirements across key Asian markets, including PMDA (Japan), MFDS (Korea), TFDA (Taiwan) and emerging frameworks in Southeast Asian nations Discuss proven strategies for managing multi-country trials in the region, including site selection and engagement in mature and emerging markets, patient recruitment in heterogeneous…

Speaker

  • Barbara Kienast

    Head of Clinical Operations & Regulatory Affairs · Graythan Regulatory Services

    Panelist