The aim of the module is to develop participant's knowledge of the regulatory strategy requirements for established active substances by providing them with the knowledge of generics, biosimilars, intellectual property and lifecycle considerations. This module will cover the legal framework supporting intellectual property, patents, data protection, market exclusivity and the EU legal basis for generics and biosimilars. Lifecycle maximization through supplementary filings and marketing strategies will be presented. Quality documentation requirements for Generics and Abridged applications including Drug substance, Drug products of various abridged applications, biologics/biotech, Bioequivalence considerations, Clinical requirements will be covered. The renewal of licences and variations will be covered in detail. Regulatory strategy will be reviewed including EU innovations (both well established and novel) that are used for licensing medicines. Students will also learn about the similarities and differences between the regulatory systems in the EU and the US. Students will complete the module and the course with an introduction to big pharma in Ireland, focusing on what big pharma are really looking for in future employees in the regulatory sector in Ireland.

1.Variations and Renewals 2. Intellectual Property and Lifecycle Considerations 3. Generics, biosimilars and Abridged applications 4. Regulatory strategy and EU Innovations 5. The similarities and differences in the EU and US regulatory systems 6. The future of the pharmaceutical industry and what big pharma want in an employee

On Successful completion of this module, students will: 1. Describe the role variations in Europe, the types, the strategy about grouping, their necessity in drug development and the evolution of licences. 2. Describe the reasons for renewals, when to do them and the importance in maintaining drug licences in Europe. 3. Demonstrate an understanding of how to maximise the life cycle of a drug product nearing the end of its regulatory data protection / patent expiry and differentiate between Intellectual Property, legal category changes, Patents, Data Protection and Market Exclusivity. 4. Demonstrate a knowledge of generics, biosimilars and abridged applications and understand their commercial importance to the pharmaceutical industry. Be knowledgeable about the EU and US regulatory systems and their similarities and differences. 5. Demonstrate a knowledge of regulatory strategy and EU innovations and how the various regulatory agencies interact with and support the design, development, production and marketing of innovative biopharma products. 6. Gain an understanding of what the pharmaceutical industry requires in terms of regulatory professionals.

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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: (i) Be agile to navigate through the regulatory application processes for variations and renewals in terms of licence maintenance in Europe. (ii) Demonstrate an understanding of the regulatory application process in terms of generic/biosimilar applications in the bio/pharmaceutical industry. (iii) Demonstrate an understanding of the strategies to maximise the product life cycle of a drug nearing the end of its regulatory data protection and patent expiry and differentiate between Intellectual Property, legal category changes, Patents, Data Protection and Market Exclusivity. (iv) Acknowledge the similarities and differences in the EU/US regulatory systems. (v) Demonstrate a knowledge of the possible future role and function of regulation within the biopharma sector in Ireland. (vi) Collaborative members of a regulatory team contributing to the efficacy to biopharma products produced in Europe. (iv) Articulate in their explanation of the biopharma regulatory environment and systems.