School of Law

SOLM102 New Medical Technologies and the Law: Medical Research and Product Regulation (Sem 1)

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

Applicable Groupings

  • LLM in Medical Law

Mode of Assessment

2.15 hour examination

Credits

15 Credits