The Regulation of 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 7MCS0014

This module introduces the core concepts of regulatory science, notably the scientific-technical basis for creating-amending regulations; the interplay of science and public policy e.g. for protecting the public and the influence of regulations on the development and lifecycle of medicines. It explores the regulatory requirements for special patient populations, commercial issues from product lifecycle development through to marketing, pharmacovigilance, and the handling of off label and unlicensed medicines. Key topics include European regulatory procedures; adverse drug reaction reporting; regulatory requirements in special populations; advertising and sales; medical aspects of the Marketing Authorisation; bioequivalence and generics; the licensing of biotechnological products and devices; and pharmacovigilance. A series of workshops cover regulatory strategy practice in relation to Clinical Trial Authorisations, preparation of Summaries of Product Characteristics and Patient information leaflets, risk minimisation, and the reclassification of the legal status of medicines.

• Gives students a working understanding of the principles of the regulation of medicines and to enable them to apply these to design a regulatory strategy for both domestic and international contexts
• Provides an understanding of how to incorporate new technologies and requirements that reflect how regulation influences the lifecycle of medicines e.g. clinical trials, marketing authorization, pharmacovigilance and the access of special patient populations to medicines.

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

• Demonstrate a critical awareness of the theory and practice of global strategic regulatory planning.
• Apply global regulatory requirements, national legislation, regulatory authorisations and other documentation to the execution of drug development programmes
• Create a regulatory strategy that supports/translates the latest advances in new medicine development blending in insights from other allied fields such as medical devices e.g. companion diagnostics and novel drug-device combinations

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 the regulation of medicines e.g. pharmaceutical physicians, scientists in R&D and medical affairs, and regulatory affairs personnel.