Vihanga Pahalawatta
Director, Device Regulatory Affairs (CDx) Abbvie
Seminars
Wednesday 20th May 2026
Panel Discussion: Discussing Decision Making by Regulatory Bodies & Aligning Development Strategy to Meet Regulatory Standards within Japan & Internationally
11:30 am
- Examining how PMDA decision-making processes compare with FDA and EMA expectations, and what this means for global CDx and therapeutic development planning
- Identifying practical strategies to align clinical evidence generation, submission timing, and stakeholder engagement to meet both Japanese and international regulatory standards
