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0. Introduction to EU Regulatory Affairs
1. Strategic Planning in Regulatory Affairs
2. Regulatory Strategy for a New Active Substance: Preclinical Development
3. Regulatory Requirements for a New Chemical Active Substance: Chemistry and Pharmacy
4. Regulatory Strategy for a New Active Substance: Global Clinical Development
5. Regulatory Control of Clinical Operations
6. Regulatory Strategy: The Market Place
7. Regulatory Strategy for Established Active Substances
8. Data Requirements for Abridged Applications and Specialised Products
9. Registration of Biological,Biotechnology and Advanced Therapy Products
10. Optimising the Contribution of Regulatory Affairs to Product Development, Maintenance and Commercialisation
11. The US Regulatory Environment
12. Medical Device Regulatory Affairs
