Module Details

Module Code: ZLAW C4100
Module Title: Regulatory Affairs for Pharmaceutics
Title: Regulatory Affairs for Pharmaceutics
Module Level:: 8
Credits:: 5
Module Coordinator: Paula Rankin
Module Author:: David Phelan
Domains:  
Module Description: To prepare the learner for a career in the highly regulated pharmaceutical and medical device sectors.
 
Learning Outcomes
On successful completion of this module the learner will be able to:
# Learning Outcome Description
LO1 Evaluate the regulatory bodies, their guidance and the application of regulations/standards, risk management across the life cycle and guidance within the pharmaceutical and medical device sectors.
LO2 Critique the content of quality management systems, auditing and how quality management systems are operated, applied, managed and reviewed and comply to multiple regulatory bodies and standards.
LO3 Examine the regulatory requirements for the design of a medical device or pharmaceutical product and appraise how clinical trials are regulated and pharmaceutical and medicinal products are evaluated prior to approval and commercialization.
Dependencies
Module Recommendations

This is prior learning (or a practical skill) that is recommended before enrolment in this module.
No recommendations listed
Co-requisite Modules
No Co-requisite modules listed
Additional Requisite Information
No Co Requisites listed
 
Indicative Content
Content
1. FDA, EU, and ISO (Regulatory bodies, Regulations, standards and guidance). 2. Quality management systems and harmonization. 3. Design and development (Quality by design). 4. Clinical evaluation of medical devices and pharmaceuticals. 5. Auditing (Maintaining an audit ready status and complying with multiple regulatory standards). 6. Regulatory filings, applications ANDA and NDA. 7. Product programme management, vigilance, surveillance. 8. Risk management (Product life cycle).
Described content
1. Structure and content of guidance documents, regulatory bodies and certification / accreditation agencies. Introducing students to compliance as a discipline and way of operating in an organisation. 2. Standards EU and FDA code of regulations as well as ISO 9001 and ISO 13485. Managing compliance to regulatory bodies in regards to design and development of products. 3. Quality management systems, to develop an understanding in the student of how a medical device or pharma company manages compliance to policies procedures and standards, and manages quality and continuous improvement initiatives. 4. Clinical evaluation of drugs and medical devices this module will demonstrate the type of data required to allow a product undergo clinical evaluation and how an organisation manufactures from the perspective of small scale start up pilot programmes for release of material for clinical trials. 5. Developing auditing as a skill the student will learn how to perform internal audits and prepare for external audits from the FDA, EU, HPRA and other regulatory agencies such as the ISO or INAB. 6. Vigilance this module will illustrate how the healthcare sector manages the safety and efficacy of the products are assured and monitored once on the market. It will also describe how a company responds to customer complaints and complies with regulations regarding serious adverse events and reporting of these events to regulators and national competent authorities? 7. How risk management is applied to medical device and pharmaceuticals across the life cycle of the products. This will develop in the student an understanding of risk as a concept in drug or medical device development as well manufacturing and introduce the terminology documentation and procedures they will be required to complete and adhere to in industry.
Module Content & Assessment
Assessment Breakdown%
Continuous Assessment40.00%
End of Module Formal Examination60.00%

Assessments

Full Time

Continuous Assessment
Assessment Type Written Report % of Total Mark 20
Timing Week 12 Learning Outcomes 1
Non-marked No
Assessment Description
Written report on the regulatory requirements for medical device design
Assessment Type Written Report % of Total Mark 20
Timing n/a Learning Outcomes 2
Non-marked No
Assessment Description
Report on the regulatory requirements for pharmaco-vigilance surveillance of pharmaceutical products
No Project
No Practical
End of Module Formal Examination
Assessment Type Formal Exam % of Total Mark 60
Timing End-of-Semester Learning Outcomes 1,2,3
Non-marked No
Assessment Description
Final written exam

SETU Carlow Campus reserves the right to alter the nature and timings of assessment

 

Module Workload

Workload: Full Time
Workload Type Workload Category Contact Type Workload Description Frequency Average Weekly Learner Workload Hours
Lecture Contact Theory lectures 12 Weeks per Stage 3.00 36
Independent Learning Non Contact CA 12 Weeks per Stage 7.42 89
Total Weekly Contact Hours 3.00
 
Module Resources
Recommended Book Resources
  • Regulatory Affairs Professionals Society. Fundamentals of US Regulatory Affairs, Tenth. [ISBN: 9780997769777].
  • Regulatory Affairs Professionals Society. Fundamentals of EU Regulatory Affairs, 8th. [ISBN: 9781946493033].
This module does not have any article/paper resources
This module does not have any other resources
Discussion Note: