Elnaz jokar
Senior Manager - Regulatory Affairs Regeneron Pharmaceuticals
Seminars
Wednesday 20th May 2026
Regulatory Submissions for Novel CDx: A Case Study of CDx & Drug Co-Development
9:00 am
- Traditional regulatory pathway for CDx co-development in Japan
- Companion vs. complementary diagnostics
- Libtayo approval lessons learned
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
