SOLM102 New Medical Technologies and the Law: Medical Research and Product Regulation (Not running 2021-22)
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.
1. From Nuremberg to Helsinki: a short history of the development of research ethics principles
2. Research ethics and research governance
3. Medicinal products licensing
4. Animal research: law, regulation and ethics
5. Clinical trials of Investigational Medicinal Products
6. Research using health data
7. Medical device licensing
8. Advanced Therapy Medicinal Products
9. Children and vulnerable groups in medical research and product licensing.
10. Issues in international/transnational health research
LLM in Medical Law
Mode of Assessment
2.15 hour examination