MSc Modules
13 Modules Relating to the Pharmaceutical Industry are Offered
0. Introduction to EU Regulatory Affairs
1. Management of Regulatory Affairs and Strategic Planning
2. Regulatory Strategy for a New Active Substance: Preclinical Development
3. Regulatory Requirements for a New Active Substance: Chemistry and Pharmacy
4. Regulatory Strategy for a New Active Substance: Global Clinical Development
5. Regulatory Control of Clinical Research
6. Regulatory Strategy: The Market Place
7. Regulatory Strategy for Submissions for Established Active Substances
8. Data Requirements for Abridged Applications and Specialised Products
9. Registration of Biological and Biotechnology Products
