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CHEM8013 - Regulatory Affairs & Auditing

Title:Regulatory Affairs & Auditing
Long Title:Regulatory Affairs & Auditing
Module Code:CHEM8013
Duration:1 Semester
Credits: 5
NFQ Level:Advanced
Field of Study: Chemistry
Valid From: Semester 1 - 2020/21 ( September 2020 )
Module Delivered in 1 programme(s)
Module Coordinator: Donagh OMahony
Module Author: Grainne Conneely
Module Description: This module gives the learner understanding of regulatory affairs related to the pharmaceutical and medical device industries. Theory and skills required for compliance auditing within these industries is covered.
Learning Outcomes
On successful completion of this module the learner will be able to:
LO1 Discuss the regulatory requirements governing the stages of drug and medical device development.
LO2 Assess the relevant regulatory standards relating to pharmaceutical and medical device industries.
LO3 Review the regulatory frameworks, ethical issues and vigilance in the pharmaceutical and medical device industries.
LO4 Critique the marketing authorization process for pharmaceuticals and medical devices in the EU and US.
LO5 Create an audit plan showing the importance of internal and external auditing in a QMS. Detail a documentation system for investigation of non-conformances, identification of root cause and corrective / preventive actions.
Pre-requisite learning
Module Recommendations

This is prior learning (or a practical skill) that is strongly recommended before enrolment in this module. You may enrol in this module if you have not acquired the recommended learning but you will have considerable difficulty in passing (i.e. achieving the learning outcomes of) the module. While the prior learning is expressed as named MTU module(s) it also allows for learning (in another module or modules) which is equivalent to the learning specified in the named module(s).

Incompatible Modules
These are modules which have learning outcomes that are too similar to the learning outcomes of this module. You may not earn additional credit for the same learning and therefore you may not enrol in this module if you have successfully completed any modules in the incompatible list.
No incompatible modules listed
Co-requisite Modules
No Co-requisite modules listed

This is prior learning (or a practical skill) that is mandatory before enrolment in this module is allowed. You may not enrol on this module if you have not acquired the learning specified in this section.

No requirements listed

Module Content & Assessment

Indicative Content
Overview of Regulatory Affairs
Overview of drug regulation legal requirements and the Regulatory Agencies, International regulatory bodies and regulatory guidelines (WHO, ICH). Review of Eudralex, MDR and IVDR.
Marketing Authorisation Process
Legislative requirements for clinical trial process and clinical development. Pharmacovigilance, Risk management. Overview of EU and US submission process, Licencing routes for EU, CTD format, Specification development (QbD), The application of Continuous Manufacturing and PAT. Intellectual property, Patents, Data protection, Market exclusivity, Generics and Biosimilars.
Post Approval Regulatory
Management of licence during lifetime of product, Variations process, PAS, Extensions, Licence Renewals, post marketing surveillance strategies, Assessment of deviations, change management, regulatory strategy around re-worked and reprocessed material. Role of the QP and Annex 16. Monographs and the role of Pharmacopoeia.
Compliance Auditing
Quality Management systems that ensure compliance with relevant legislation and guidelines. Interpretation of GMP and ISO guidelines. Non-conformances, Identification of root cause, Root Cause Analysis, CAPA and Change Control.
Audit Methodology
The role and characteristics of an auditor, Audit methodologies, Documentation and tools. Certification and regulatory bodies relevant to the analyst. External Audit and Assessment. Reference to relevant standards e.g. ISO 9000, ICHQ10 Pharmaceutical Quality System, ISO17025.
Assessment Breakdown%
Course Work100.00%
Course Work
Assessment Type Assessment Description Outcome addressed % of total Assessment Date
Other Multiple Choice Questions / Short Answer Questions 1,2,3,4 30.0 Week 7
Project Produce a research based report and a presentation on an assigned topic 2,3,5 30.0 Week 10
Written Report Create an audit plan on an assigned topic. 5 10.0 Week 11
Open-book Examination Assessment on interpretation of course material 1,3,5 30.0 Week 13
No End of Module Formal Examination
Reassessment Requirement
Repeat examination
Reassessment of this module will consist of a repeat examination. It is possible that there will also be a requirement to be reassessed in a coursework element.

The institute reserves the right to alter the nature and timings of assessment


Module Workload

Workload: Full Time
Workload Type Workload Description Hours Frequency Average Weekly Learner Workload
Lecture Theory 1.0 Every Week 1.00
Tutorial Application of theory, principles and regulatory guideline review. 1.0 Every Week 1.00
Independent & Directed Learning (Non-contact) Lecturer and self-directed Study 5.0 Every Week 5.00
Total Hours 7.00
Total Weekly Learner Workload 7.00
Total Weekly Contact Hours 2.00
Workload: Part Time
Workload Type Workload Description Hours Frequency Average Weekly Learner Workload
Lecture Theory 1.0 Every Week 1.00
Tutorial Application of Theory and principles, teamwork problem solving 1.0 Every Week 1.00
Independent & Directed Learning (Non-contact) Self-directed Study 5.0 Every Week 5.00
Total Hours 7.00
Total Weekly Learner Workload 7.00
Total Weekly Contact Hours 2.00

Module Resources

Recommended Book Resources
  • John J. Tobin and Gary Walsh 2008, Medical Product Regulatory Affairs : Pharmaceuticals, Diagnostics, Medical Devices [ISBN: 9783527623044]
  • RAPS 2020, Fundamentals of Pharmaceutical and Biologics Regulations [ISBN: 9781947493520]
  • RAPS 2020, Fundamentals of Medical Device Regulations [ISBN: 9781947493506]
  • Stephen F. Amato, Robert M., Jr. Ezzell, and B Amato 2014, Regulatory Affairs for Biomaterials and Medical Devices [ISBN: 9780857099204]
Supplementary Book Resources
  • Mira Harrison-Woolrych and Patrick Waller 2017, An Introduction to Pharmacovigilance [ISBN: 9781119289746]
  • Alexander Schuhmacher, Markus Hinder, and Oliver Gassmann 2016, Value Creation in the Pharmaceutical Industry : The Critical Path to Innovation [ISBN: 9783527693412]
This module does not have any article/paper resources
Other Resources

Module Delivered in

Programme Code Programme Semester Delivery
CR_SQSDA_8 Higher Diploma in Science in Quality Systems Validation with Data Analytics 1 Mandatory

Cork Institute of Technology
Rossa Avenue, Bishopstown, Cork

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Email: help@cit.edu.ie