Who will benefit from this module?
This introductory module is an ideal primer for those new to the fields of clinical research or regulatory affairs. It will also provide valuable background information for administrative, sales and other staff in the pharmaceutical and biotechnology industries, enabling them to understand better the context in which they work.
- Describe the key events in the historical development of the modern pharmaceutical industry.
- Outline the key codes of practice and regulatory processes.
- Explain how clinical trials fit within the drug development process.
- Describe the economic environment within which pharmaceutical companies operate.
CPD Points: 1.5
Assessment: Multiple-choice mastery assessment
History - Factors that gave rise to the modern framework of regulation of clinical trials are traced.
Codes and regulations - The principal elements of regulation of clinical trials are set out. The regulatory frameworks of the USA, Europe and Japan are outlined. International harmonisation of requirements through the work of ICH is discussed, with particular reference to Good Clinical Practice.
Drug development - The long and financially risky process of developing a drug is described. The various stages of discovery, nonclinical and clinical development are detailed.
Global market - Commercial considerations in drug development are described. Issues such as financial risk, pharmacoeconomics, patent life and generics are discussed.