The aim of the module is to introduce participants to the variety of regulatory affairs interactions involved and their importance in drug development and product marketing in the biopharma sector. Students will receive a thorough overview of the fundamentals of pharmaceutical development. They will cover the fundamentals of pharmaceutical manufacturing, both upstream and downstream, will be presented including biopharmaceutics, parenteral dosage forms, sterility and biotechnology formulation development. GMP, Development and manufacturing initiatives (ICH Q8, Q9, Q10, Q11, QbD, PAT Design space, Continuous manufacturing, Supporting site product changes will be considered. The pivotal role of regulatory affairs including submission of documents, participation in global regulatory strategy, and medical information and the EU regulations will be developed. Finally, students will discover the importance of IPHA (The Irish Pharmaceutical Healthcare Association) to the pharmaceutical industry in Ireland.

1. Overview of traditional drug development processes and what can go wrong 2. Fundamentals of pharmaceutical development 3. Manufacturing considerations 4. Pivotal role of Regulatory Affairs in the global context 5. Medical information and the EU regulations 6. An introduction to the Irish Pharmaceutical Healthcare Association (IPHA) and its importance in Ireland 7. Case study

On successful completion of this module, students will be able to: 1. Describe the traditional drug substance to drug product development process with respect to the regulatory industry and agencies. 2. Demonstrate a knowledge of manufacturing considerations and GMP in the biopharmaceutical industry. 3. Demonstrate a knowledge of EU regulations and their importance for industry. 4. Acknowledge the layout of the Common Technical Document. 5. Demonstrate a knowledge of what the regulators want to see implemented. 6. Demonstrate a clear understanding of how the global regulatory environment operates and how Europe and Ireland fit into the global picture in this context. 7. Articulate the need, importance and advantage of IPHA in the Pharmaceutical industry in Ireland. 8. Demonstrate an understanding of the background to the Medical Information function and how it links to Regulatory Affairs.

On successful completion of this module, students will be able to 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 regulation 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 (SMEs) in the area and will be knowledgeable on current legislation and application. Graduate attributes: On successful completion of this module, students will be: (i) Knowledgeable about the drug development processes and how they link to regulatory affairs within the biopharma sector. (ii) Agile to demonstrate an understanding of the global drug development process and Good Manufacturing Practice (GMP) . (iii) Aware of the Common Technical Document (CTD) and applicable guidelines. (iv) Collaborative members of a regulatory team contributing to the efficacy to biopharma product development. (v) Articulate in their explanation of drug development in the biopharma sector with respect to the regulatory environment and systems. (vi) Agile to describe the need, importance and advantage of IPHA in the Pharmaceutical industry in Ireland. (vii) Agile to demonstrate an understanding of the background to the Medical Information function and how it links to Regulatory Affairs.