Ethics and Good Practice for Medicines

*Please note that applicants to this short course should go via King's Apply (click red 'Apply' button on the right of this page) and select the following programme*:

Pharmaceutical Medicine Non-Award (Part-time): Module code 7BBP0013

This module provides training over five days on the concepts of ethics, good practice and risk/benefit in the development and marketing of medicines. It introduces the principles of ethics before focusing on ethical practice and the regulation of these practices. It covers typical issues of ethics that arise in biomedical research and pharmaceutical medicine such as the clinical development of medicines and the commercialisation of medicines. A significant proportion of the time in this 5-day module will be devoted to discussions and workshops.

This module aims to:

• Enable students to critically assess the ethical principles and frameworks that impact upon the development and marketing of medicines.
• Give students an in depth understanding of the relevance and importance of corporate and public ethics on the development and marketing of medicines.
• Provide an overview of the professional standards, codes and rules impacting the pharmaceutical industry (including GxP).
• Enable students to appreciate the ethical aspects of medicine development and clinical trials (including the role and responsibilities of Ethics Committees).
• Provide the ability to appraise the range of strategies for medicine commercialisation and their ethical consequences.

By the end of this module students will be able to:

• Review the concepts of ethics, good practice and risk/benefit in the development and marketing of medicines and how the industry is engaged to protect patients and the public.
• Create multi-national clinical and commercial development programmes that apply patient involvement and operational plans, are ethical and subscribe to GxPs.
• Critically analyse the relevant clinical and non-clinical studies that ethically justify risk/benefit.

Minimum entry requirements are either a medical degree (such as an MBBS) or a 2:1 first degree in pharmacy, pharmacology, biology, biochemistry, chemistry or related subject. The course will suit individuals seeking to develop a practical understanding of importance of ethics in medicine development and life-cycle management by the pharmaceutical industry e.g. pharmaceutical physicians, scientists in R&D and medical affairs, and regulatory affairs personnel.