Latest Module Specifications
Current Academic Year 2025 - 2026
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Description The module is intended to introduce the regulatory context in which medicinal products, particularly biotherapeutics and those produced through biotechnology processes, are developed and made available to patients. The module sets out to explain and develop the working interface between science, technology, manufacturing processes and the licensing/regulatory environment which controls medicines. The global organisation of relevant regulation is outlined, particularly the roles of ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), CFR (Code of Federal Regulations) and EU. Due emphasis is placed on issues related to establishment of quality standards for biotechnology derived products as well as the required information on safety and efficacy as appropriate. There are obvious interrelationships and connections to other modules e.g. GMP, material characterization, formulation and analytical technologies and methodologies. These are not repetitive treatments of the same subject but a necessary distinction to accommodate difference in depth in specific areas e.g. characterization and stability in a second treatment. The significance of ICH Q8, 9 and 10 is also discussed. The module will also address regulatory issues surrounding Clinical Trials, Pharmacovigilance and Biosimilars. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Learning Outcomes 1. Demonstrate a sytematic understanding of the global regulatory framework for biotechnology derived pharmaceuticals 2. Demonstrate a systematic understanding of how the nature and production of biotechnology products affects quality, safety and efficacy 3. Critically evaluate key EU Directives and Institutions (MEA, CHMP, CVMP) 4. Gain advanced knowledge of the relevance to regulatory affairs of clinical trials 5. Demonstrate a systematic understanding of the elements of the CTD (Common Technical Document) 6. Gain critical awareness of the regulatory approaches to Biosimilars 7. Demonstrate a systematic understanding of the role of Pharmacovigilance and ICH Q10 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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All module information is indicative and subject to change. For further information,students are advised to refer to the University's Marks and Standards and Programme Specific Regulations at: http://www.dcu.ie/registry/examinations/index.shtml |
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Indicative Content and Learning Activities
Regulatory Affairs Introduction of the regulatory context in which medicinal products, particularly biotherapeutics and those produced through biotechnology processes, are developed and made available to patients. Overview of the working interface between science, technology, manufacturing processes and the licensing/regulatory environment which controls medicines. Outline of relevant global regulations, particularly the roles of ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), CFR (Code of Federal Regulations) and EU. Introduction to the establishment of quality standards for biotechnology derived products as well as the required information on safety and efficacy as appropriate. The interplay between the regulatory/commercial aspects and patenting/IP elements will be highlighted. Regulatory Affairs Science for Biotechnology Products Preamble Introduction to the regulatory context in which medicinal products and specifically those from biotechnology processes are developed and made available to patients throughout the product lifecycle. Sources of information for Regulatory Affairs. General Attributes and legal status of Biological/Biotechnological Medicinal Products Summary issues related to the development, characterization and specifications of biotechnology derived products; Stability issues relevant to biotechnology products; Biosimilars. Regulatory Framework - General National aspects; Health Products Regulatory Authority (HPRA), European aspects (European Medicines Agency EMA), International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Regulatory Framework - Particular Variation Process change and Comparability The Common Technical Document (CTD) Regulatory Aspects of ICH Q8,9 and 10 (Pharmaceutical Development, Quality Risk Management and Pharmaceutical Quality System) Pharmacovigilance Clinical Trials | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Indicative Reading List Books:
Articles:
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Other Resources
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