MSc Pharmaceutical Industrial Advanced Training (PIAT) / Course details

Year of entry: 2020

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

  • 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

This is a distance learning unit with a workbook in the style of lecture notes. There are  questions at the end of each unit to ensure that the student has understood the content of what has been read.

A 6,000-word written assignment (or 2 x 3,000-word assignments) with a title agreed by the tutor is an opportunity to study in more depth a subject that might be useful to the future career of the student. 

 

Knowledge and understanding

  • Appreciate the work involved with the preparation of submissions to Health Authorities, particularly in the areas of development, manufacture and quality assurance. 

Intellectual skills

  • To critically review and analyse the data required for applications to Health Authorities.
  • To know where to look for solutions to problems of safety, quality and efficacy of medicinal products.  

Practical skills

  • To understand the assembly of data for the common technical document.

Transferable skills and personal qualities

  • To communicate with other departments in the company on the general requirements of Regulatory Authorities.
  • To understand the importance of managing data and making decisions on the facts presented.

Assessment methods

Method Weight
Written assignment (inc essay) 100%

Feedback methods

Provisional marks and feedback for coursework returned within 15 working days.

Exam marks and final marks returned after ratification at exam board. 

Study hours

Independent study hours
Independent study 150

Teaching staff

Staff member Role
Matthew Shaw Unit coordinator

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