Course Overview
Participants will gain comprehensive insights into the regulatory framework governing New Drug Applications (NDAs) and Supplemental New Drug Applications (SNDAs), including submission types, data requirements, and the review process. The program also delves into various regulatory impact assessments, data analysis techniques, and the latest developments in assessment methodologies.
Features
- Interactive Lectures
- Case Studies
- Hands-on Exercises
- Group Discussion
Target audiences
- Professionals in the pharmaceutical industry involved in clinical trial management, regulatory affairs, quality assurance, and drug development.
Instructor
