The module provides a systematic examination of ethical and legal requirements for conduct of clinical research with an emphasis on regulatory control.
This module aims to provide:
- Systematic overview of the ethical requirements of pharmaceutical medicine.
- Systematic overview of the legal aspects of regulatory control of clinical research
Comprehensive insight into legal basis and ethical principles of clinical research and pharmaceutical development.
- Legal authorization of clinical research
- National and European controls of clinical research
- Legal basis, current and future
- Ethical principles: consent, confidentiality, contractual arrangements, fraud, compensation
- Prescription medicines Code of Practice authority
- Medical ethics and company needs
- Benefits versus risk, Philosophy of ethics
Medicine regulation and recommendations