Registry

Module Specifications

Current Academic Year 2012 - 2013
Please note that this information is subject to change.

Module Title	Regulatory Affairs Sc. for Biotech Products
Module Code	BE585
School	School of Biotechnology
Online Module Resources
Module Co-ordinator	Semester 1: Jenny Lawler Semester 2: Jenny Lawler Autumn: Jenny Lawler
Module Teacher	Jenny Lawler
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, CFR and EU. Due emphasis is placed on issues related to establishment of quality standards for biotechnology derived products as well as required information on safety and efficacy as appropriate. There are obvious interrelationships and connections to other modules eg GMP, material characterisation, 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 eg characterisation 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 Trial, Pharmacovigilance and Biosimilars.

Learning Outcomes

1. Demonstrate an understand of the global regulatory framework for biotech derived pharmaceuticals
2. Demonstrate an understanding of how the nature and production of biotech products affects quality, safety and efficacy
3. Discuss key EU Directives and Institutions (MEA, CHMP, CVMP)
4. Describe the relevant to regulatory affairs of clinical trials
5. Demonstrate an understanding of how the CTD (Common Technical Document) works
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*
Lecture	16	No Description
Independent learning	109	No 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 and definitions - Regulatory.

General Attributes and legal status of Biological/Biotechnological Medicinal products.
Summary issues related to the development and characterization of biotechnology derived products.

Regulatory framework - general.
Regulatory framework - particularVariation, Process change and Comparability.

ICH Q8,9.10.
Pharmacovigilance.

Assessment Breakdown
Continuous Assessment	100%	Examination Weight	0%

Course Work Breakdown
Type	Description	% of total	Assessment Date
Assignment	Tutor Marked	40%	n/a
In Class Test	n/a	60%	n/a

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
This module is category 1

Indicative Reading List

Ed Jorh Knablein: 2005, E.A. in Modern Biopharmaceuticals, Vol 4, Wiley-VCH, 1669-1708,
Walsh, G and Murphy B: 1999, Biopharmaceuticals, Springer Verlag,
Oehler -Tomamichel, K.: 2005, Comparability of biotechnological/biological. The Regulatory Rapporteur 2.2.,
Taylor, H.: 2004, Characterization and specifi¬cations for biopharmaceuticals. The Regulatory Rapporteur 1.12.,
Zeid, R. L.: 2000, Regulatory and development issues in the demonstration of therapeutic equivalence for multisource biotech-derived pharmaceuticals. Drug Inform. J 34, 919-959.,
Wenzel, A.: 2003, Drug regulatory affairs for biotech drugs. The ESRA Rapporteur 10.3.,

Other Resources

5942, Website, 0, GMP guidelines, http://dg3.eudra.org/F2/eudralex/vol-4/home.htm, 5943, Website, 0, Quality Safety and Efficacy: guidelines and links, ich.org, eudra.org, 5944, Website, 0, CHMP, CVMP, COMP, HPMC, http://www.emea.eu.int, 5945, Website, 0, CTD information, http://www.ich.org/cache/compo/276-254-1.html, 5946, Website, 0, ICH Q7AGMP Guidelines. See www.ich.org,

Array

Programme or List of Programmes

GDBE

Graduate Dip in Bioprocess Engineering

MSBE

Master of Science in Bioprocess Engineer

SAMPB

STAND ALONE MODULE (BIOTECHNOLOGY)

Timetable this semester: Timetable for BE585

Date of Last Revision

31-JAN-12

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