This module is not running for 2024-25 entry. Check our LLM and Diploma module list to see other related modules you could take.
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.SyllabusWeek 1: 1. From Nuremberg to Helsinki: a short history of the development of research ethics principles2. Research ethics and research governanceWeek 2:3. Medicinal products licensing4. Animal research: law, regulation and ethicsWeek 3:5. Clinical trials of Investigational Medicinal Products6. Research using health dataWeek 4:7. Medical device licensing8. Advanced Therapy Medicinal ProductsWeek 5:9. Children and vulnerable groups in medical research and product licensing.10. Issues in international/transnational health research
15 Credits