SOLM102 New Medical Technologies and the Law: Medical Research and Product Regulation

Module Description

This module introduces the principles of ethics, governance and regulation of biomedical research and new product regulation in global context, though with a particular focus on the legal implementation of these principles in the law of England and Wales.

Syllabus

Week 1:
1. From Nuremberg to Helsinki: a short history of the development of research ethics principles
2. Research ethics and research governance

Week 2:
3. Medicinal products licensing
4. Animal research: law, regulation and ethics

Week 3:
5. Clinical trials of Investigational Medicinal Products
6. Research using health data

Week 4:
7. Medical device licensing
8. Advanced Therapy Medicinal Products

Week 5:
9. Children and vulnerable groups in medical research and product licensing.
10. Issues in international/transnational health research

Credits

15 Credits