Module 3 2019

The flow of the workshop

1. Lecture on CMC In the drug development programme

2. Lectures on drug substance development

3. Lecture on CMC Project management

4. Case study 1 on drug substance

5. Lectures on drug product development

6. Lecture on GMP for clinical supply

7. Case study 2 on drug product

8. Lecture on Regulatory Agency Perspective

The Organisation for Professionals in Regulatory Affairs