Module: Regulatory Affairs Sc. for Biotech Products

Module Specifications.

Current Academic Year 2024 - 2025

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Date posted: September 2024

Module Title	Regulatory Affairs Sc. for Biotech Products
Module Code	BE585 (ITS) / BTE1036 (Banner)
Faculty	Science & Health	School	Biotechnology
Module Co-ordinator	David Collins
Module Teachers	Brian Freeland, Denise Harold, Paul Cahill
NFQ level	9	Credit Rating	5
Pre-requisite	Not Available
Co-requisite	Not Available
Compatibles	Not Available
Incompatibles	Not Available

Repeat examination
Repeat assessment in August

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.

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

*Type*	*Hours*	*Description*
Workload	Full-time hours per semester
Lecture	16	Asynchronous/synchronous lectures
Independent Study	68	Literature and database searches and engagement with taught content.
Assignment Completion	40	Self-directed completion of written assignment and preparation of presentation.
Class Presentation	1	Individual presentations of assignment topics.
Lecture	16	Asynchronous/synchronous lectures
Independent Study	68	Literature and database searches and engagement with taught content.
Assignment Completion	40	Self-directed completion of written assignment and preparation of presentation.
Class Presentation	1	Individual presentations of assignment topics.
Total Workload: 250

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

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

Assessment Breakdown
Continuous Assessment	100%	Examination Weight	0%

Type	Description	% of total	Assessment Date
Course Work Breakdown
Assignment	Assigned assignment topics are based on topics covered during the course of the module.	50%	Week 12
Presentation	Individual presentation covering topics covered throughout the module. The presentations will take place just before semester 2 start.	50%	Other

Reassessment Requirement Type
Resit arrangements are explained by the following categories: Resit category 1: A resit is available for both* components of the module. Resit category 2: No resit is available for a 100% continuous assessment module. Resit category 3: No resit is available for the continuous assessment component where there is a continuous assessment and examination element.
* ‘Both’ is used in the context of the module having a Continuous Assessment/Examination split; where the module is 100% continuous assessment, there will also be a resit of the assessment
This module is category 1

Indicative Reading List

Wenzel, A.F. and Sonnegan, E.A.; Editor: Jörg Knӓblein: 2005, Modern Biopharmaceuticals, Vol 4, Wiley-VCH,
Eudralex: 0, Volume 3, www.eudra.org,
ICH Official Website: 0, ICH Guidelines, www.ich.org,
John J. Tobin, Gary Walsh: 0, Medical Product Regulatory Affairs; Pharmaceuticals, Diagnostics, Medical Devices, 978-3-527-64471-1
Editor: Jörg Knӓblein: 2013, Modern Biopharmaceuticals: Recent Success Stories, Wiley-VCH Verlag GmbH & co. KGaA, 9783527322831

Other Resources

61381, Website, European Medicines Agency, 0, CHMP (Committee for Medicinal Products for Human Use); CVMP (Committee for Medicinal Products for Veterinary Use); COMP (Committee for Orphan Medicinal Products); HMPC (Committee on Herbal Medicinal Products)., http://www.ema.europa.eu/ema/, 61382, Website, 0, ICH Information, http://www.ich.org, 61383, Website, 0, FDA CFR, http://www.gpoaccess.gov/cfr/index.html, 61384, Website, 0, CTD Information, http://www.ich.org/products/ctd.html, 61385, Website, 0, International Federation of Pharmaceutical Manufacturers & Associations, http://www.ifpma.org/, 61386, Website, 0, Health Products Regulatory Authority, http://www.hpra.ie, 61387, Website, 0, The European Pharmacopoeia (Pharmacopoea Europaea, Ph.Eur.), 61388, Website, 0, The United States Pharmacopeia (USP),