MSc Pharmaceutical Technology and Quality Assurance

Year of entry: 2022

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Course unit details:
Regulatory Affairs (PIAT 11)

Unit code PHAR71110
Credit rating 15
Unit level FHEQ level 7 – master's degree or fourth year of an integrated master's degree
Teaching period(s) Variable teaching patterns
Offered by Pharmacy
Available as a free choice unit? No

Overview

This unit covers the history and background to the regulation of medicines, the legal basis of controls, and the advice available. This includes the requirements for marketing authorisations and the control of clinical trials, manufacture and importation of medicines, and the management of variations.

 

Aims

The unit aims to: 

  • To provide an insight into the regulatory requirements of the European Health Authorities in controlling the development and marketing of medicinal products.
  • To compare European legislation and guidelines with those of the USA and Japan.

 

Teaching and learning methods

Students are provided with the learning material in soft copy form. The learning material comprises 10 chapters covering the key areas of regulation. Each chapter contains a number of exercises for students to check their learning as they progress through the unit. Reference lists of further reading are provided early in the unit, allowing the student to investigate the subject area more deeply, and the unit tutor is available to answer queries and provide guidance as required. The face-to-face workshop at the annual workshop event explores key areas of the unit through a range of hands-on exercises and practical demonstrations.

 

Knowledge and understanding

Students will be able to appreciate the work involved with the preparation and maintenance of regulatory submissions to various Health Authorities, particularly in the areas of research, development and testing, and manufacture and quality assurance of medicines for human use.

 

Intellectual skills

Students will be able to:

  • Review and analyse for completeness the data required for applications to Health Authorities. 
  • Know where to look for solutions to problems of safety, quality and efficacy of medicinal products.

Practical skills

Students will be able to:

  • Understand the assembly of required data for the common technical document (CTD)
  • Know how to maintain the relevance of the CTD over the lifecycle of the medicinal product

Transferable skills and personal qualities

Students will be able to:

  • Recognise the importance of timely two-way communication between concerned departments in the company on the general and, where relevant, specific and up-to-date requirements of Regulatory Authorities.

  • Understand the importance of managing data and making decisions on the facts presented.

     

     

Assessment methods

Method Weight
Written assignment (inc essay) 100%

Feedback methods

Feedback returned by email within 15 working days.

Recommended reading

•    Griffin, J. P. (2010) The Development of Human Medicines Control in Europe from Classical Times to the 21st Century, in Principles and Practice of Pharmaceutical Medicine, Third Edition (eds L. D. Edwards, A. W. Fox and P. D. Stonier), Wiley-Blackwell, Oxford, UK.
•    Redmond, Kathy (2004) The US and European Regulatory Systems: A Comparison, Journal of Ambulatory Care Management 27 (2) p105-14
•    Medicines and Healthcare Products Regulatory Agency 2016 https://www.gov.uk/government/organisations/medicines-and-healthcareproducts-regulatory-agency
•    Pharmaceutical Administration and Regulations in Japan 2015 http://www.jpma.or.jp/english/parj/whole.html
•    US Food and Drug Administration Rules and Regulations http://www.fda.gov/RegulatoryInformation/RulesRegulations/
 

Study hours

Independent study hours
Independent study 150

Teaching staff

Staff member Role
Michael Robertson Unit coordinator

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