- Program Objective
- This program aims to strengthen practical regulatory affairs capabilities by providing foundational education on regulatory strategy at the early R&D stage, along with hands-on training in preparing regulatory documents and performing real-world RA tasks.
- Program Details
- Program period: Mar-Nov, 2026
Program:
① Education program covering basic regulatory strategy at early development stages, regulatory authority interaction strategies, and case-based lectures on approval examples
② Course structure
- Drug approval training (Introductory course, April): Basic RA education to support understanding of domestic and international regulatory systems, including RA fundamentals, international approvals, and decision making and regulation at each stage of new drug development.
- Drug approval training (Practical course, July): Practical RA training focused on case analysis and CTD preparation to support IND submission.
- Biologics approval training (Advanced course, October-November): Applied RA training on biologics, covering biologics approval strategies, case comparisons, and nonclinical and clinical strategies and requirements.
* Note: The training schedule may be adjusted depending on internal circumstances.
- Contact
R&D Enabling & Strategy Team: rnd_project@kddf.org