The aim of the module is to introduce participants to the legal basis for the regulation of medicines in the bio/pharmaceutical industry. The module will teach delegates how to improve their interactions with the regulatory agencies/authorities, providing them with knowledge of the regulatory agencies and systems in use and how to follow and interpret the current legislation in the biopharmachem sector.

1. Legal basis for regulation of medicines 2. Interactions of regulatory affairs with EU agencies The first lecture is on the Legal basis for the Regulation of Medicine. The aim is to introduce students to the legal environment of pharmaceutical regulation. The second lecture for this module covers Interactions of Regulatory Affairs with EU agencies. The aim is to offer helpful tips and guidance on how to improve relations with the EU agencies and is based on the first hand, current, industry experience of the lecturer.

On successful completion of this module, students will be able to: 1. Describe the legal basis for the regulation of biopharma products. 2. Demonstrate an understanding of the history of regulation, the importance of the regulatory function, the key regulatory procedures and how they support the development, production and marketing of biopharma medicinal products. 3. Demonstrate an understanding of the key EU authorising bodies / competent agencies, the law (in brief) and the role of the regulatory affairs department / regulatory professional. 4. Demonstrate an understanding of who and what the key interactions might be with/on when dealing with the Regulatory Agencies. 5. Describe the role of the European Medicines Agency (EMA) and demonstrate an understanding of some of the interactions and procedures that you may expect to use to license medicines in Europe. 6. Demonstrate an increased knowledge on methods to maximise potential positive outcomes from interactions with EU Regulatory bodies. 7. Demonstrate a knowledge of regulatory support systems and how they interact with and support the design, development, production and marketing of biopharma products.

On successful completion of this module, students will acknowledge their professional and ethical responsibility for regulation for the biopharma industry - using the skills and knowledge gained from the course, students will become major contributors to regulatory teams within their own organizations.

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The module as outlined in the syllabus, is delivered as a combination of tutor lead direct learning and tutor lead non-direct learning i.e. a combination of classroom and on-line lectures. Intersession work will be facilitated through an online learning platform. The tutors will be Subject Matter Experts (SME) in the area and will be knowledgeable on current legislation and procedures. Graduate attributes: On successful completion of this module, successful participants will be (i) Knowledgeable about the role and function of regulation within the biopharma sector both from an industry perspective and the perspective of the EU regulatory authorities. (ii) Creative in effectively understanding the role and scope of the regulatory agencies and how to influence them. (iii) Agile to contribute to the biopharma industry by understanding about the global regulation of medicinal products. (iv) Knowledgeable to articulate their understanding of the global biopharma regulatory environments and systems.