PHAR40240

The aim of this module is to outline the role of regulatory affairs in the pharmaceutical, biopharmaceutical, medical devices, foods and cosmetics industries.
A wide range of products and services available on the open market are subject to regulation by government agencies. This is generally for the protection of the public, to ensure products are safe and that they deliver some societal benefit. Human medicines and medical devices, veterinary medicines and agrichemicals, foods and food supplements are some of the most strictly regulated products in this regard. It is the responsibility of the Regulatory Affairs professional to ensure that manufacturers of regulated products in these industries are complying with all regulations and laws concerning their products.
Students will explore the global regulatory environment and learn about the importance of international standards and harmonised guidelines in the pharmaceutical and medical device sectors. Students will learn about all aspects of medicines regulation throughout the drug development process from initial discovery, on to pre-clinical and clinical development, and through to pharmacovigilance.

Students will also learn about current issues in the regulatory affairs world from industry-based regulatory affairs professionals and representatives of national regulatory bodies. Current ‘hot-topics’ including regulation of advanced therapies (biotherapeutics, gene therapies, vaccines etc.), the evolution of the biosimilars market and the increasing role of pharmacoeconomics will be discussed. In addition, the new EU Medical Device and Clinical Trials Regulations will be topics of focus.

The module will explore the interface between scientific understanding and regulatory interpretations, arming students with the knowledge and vocabulary necessary to operate in the world of regulatory affairs.