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Module Specifications

Archived Version 2018 - 2019

Module Title Regulatory Affairs Sc. for Biotech Products
Module Code BE585
School School of Biotechnology

Online Module Resources

Module Co-ordinatorDr Jenny LawlerOffice NumberX221
NFQ level 9 Credit Rating 5
Pre-requisite None
Co-requisite None
Compatibles None
Incompatibles None
Description

The module is intended to introduce the regulatory context in which medicinal products, particularly 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 an understanding of the global regulatory framework for biotechnology derived pharmaceuticals
2. Demonstrate an understanding of how the nature and production of biotechnology products affects quality, safety and efficacy
3. Discuss key EU Directives and Institutions (MEA, CHMP, CVMP)
4. Describe the relevance to regulatory affairs of clinical trials
5. Demonstrate an understanding of the elements of the CTD (Common Technical Document)
6. Discuss the regulatory approaches to Biosimilars
7. Demonstrate an understanding of the role of Pharmacovigilance and ICH Q10



Workload Full-time hours per semester
Type Hours Description
Lecture16No Description
Independent Study109No Description
Total Workload: 125

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 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 Assessment100% Examination Weight0%
Course Work Breakdown
TypeDescription% of totalAssessment Date
Reassessment Requirement
Resit arrangements are explained by the following categories;
1 = A resit is available for all components of the module
2 = No resit is available for 100% continuous assessment module
3 = No resit is available for the continuous assessment component
Unavailable
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

11463, 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/, 11455, Website, 0, ICH Information, http://www.ich.org, 11456, Website, 0, FDA CFR, http://www.gpoaccess.gov/cfr/index.html, 11457, Website, 0, CTD Information, http://www.ich.org/products/ctd.html, 11458, Website, 0, International Federation of Pharmaceutical Manufacturers & Associations, http://www.ifpma.org/, 11459, Website, 0, Health Products Regulatory Authority, http://www.hpra.ie, 11460, Website, 0, The European Pharmacopoeia (Pharmacopoea Europaea, Ph.Eur.), 11461, Website, 0, The United States Pharmacopeia (USP),
Programme or List of Programmes
GCBEGraduate Cert in Bioprocess Engineering
GDBEGraduate Dip in Bioprocess Engineering
MSBEMSc in Bioprocess Engineering
SAMPBSTAND ALONE MODULE (BIOTECHNOLOGY)
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