The aim of the module is to introduce participants to the content and structure of the Marketing Authorisation Application (MAA) and the EU filing procedures namely, the Mutual Recognition Procedure (MRP), the Centralised Procedure (CP) and the Decentralised Procedure (DCP). This module will also cover the role of the Quality function within a pharmaceutical company and how to document pharmaceutical development and manufacture of the drug substance and drug product in the dossier. It will cover the practical issues associated with Inspections, working both in the EU and the US. Finally, the future and expected direction of regulation from is covered.

Role of Quality (Chemistry, Manufacturing and Controls (CMC) data in the overall drug development programme. The structure and content of the Marketing Authorisation Application (MAA): The Common Technical Document (CTD), Quality data presentation within the CTD, EU regional information within CTD. Status of guidelines and European Pharmacopeial texts and harmonisation efforts, Drug Master Files and Certificates of Suitability, Documenting pharmaceutical development and manufacture of the drug substance and product in the dossier. Development of drug substance and drug product, Chemistry and pharmaceutical sections of the dossier. EU regulatory filing procedures: Centralised procedure (CP) - Scope, Pre-submission activities, Scientific Advice, Practical handling and outcomes. Decentralised (DCP) and Mutual Recognition (MRP) procedures - practical issues in the choice, the Reference Member State, Managing the procedures, role of CMDh, Referrals. Regulatory Inspections - EU and US and the future and expected direction of regulation.

On successful completion of this module, students will be able to: 1. Describe the role of quality data in the overall drug development landscape. 2. Describe the presentation of the quality data in the Marketing Authorisation Application (MAA). Demonstrate a knowledge of the layout of the Common Technical Document (CTD) and its use in the overall MAA. 3. Demonstrate a knowledge of all the EU regulatory filing procedures, why they are used, how they are used, their differences and timelines. 4. Demonstrate a knowledge of the strategic implications of choosing one licensing route over another. 5. Demonstrate an understanding of the rationale for inspections and their differences in the EU and US. 6. Demonstrate an understanding of the expected direction of regulations in Ireland.

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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: Successful participants will be: (i) Able to describe the role of quality data in the overall drug development landscape and how it is presented in the MAA. (ii) Demonstrate an understanding of the layout of the Common Technical Document (CTD). (iii) Demonstrate knowledge about regulatory requirements and filing procedures within the biopharma sector. (iv) Demonstrate an understanding of the rationale for inspections and their differences in the EU and US. (v) Demonstrate an understanding of the potential for the future of regulation in Ireland. (vi) Collaborative members of a regulatory team contributing to the efficacy to biopharma products produced in Europe.