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CM5047: REGULATORY ASPECTS OF PHARMACEUTICAL DEVELOPMENT (2021-2022)

Last modified: 31 May 2022 13:05


Course Overview

This course will provide an overview of the regulatory framework controlling drug development in Europe and the USA and how these will link to the emerging Asian sector.

Course Details

Study Type Postgraduate Level 5
Session First Sub Session Credit Points 15 credits (7.5 ECTS credits)
Campus Aberdeen Sustained Study No
Co-ordinators
  • Dr Rainer Ebel
  • Dr Rebecca Walker

What courses & programmes must have been taken before this course?

  • Any Postgraduate Programme

What courses cannot be taken with this course?

  • CM5547 Regulatory Aspects of Pharmaceutical Development (Studied)

Are there a limited number of places available?

No

Course Description

The origins of the regulatory framework and the development of good manufacturing practice (GMP) will be discussed in the context of the European Medical Agency (EMA) and the USA Federal Drug Agency (FDA) guidelines. The role of the International Council of Harmonisation (ICH) and the attempt to bring the European and American authorities closer together and to develop a worldwide unified framework to include the rapidly emerging Asian sector will be explained. The importance and evolution of good distribution practice (GDP) will be discussed and its growing importance highlighted. The role of the worldwide pharmacopoeias will be discussed and their value in pharmaceutical manufacture and development described.


Details for second half-session courses, including assessments, may be subject to change until 23 December 2022.

Contact Teaching Time

Information on contact teaching time is available from the course guide.

Teaching Breakdown

More Information about Week Numbers


Details for second half-session courses, including assessments, may be subject to change until 23 December 2022.

Summative Assessments

Exam - Multiple Choice Questions

Assessment Type Summative Weighting 50
Assessment Weeks Feedback Weeks

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30 multiple choice questions

Learning Outcomes
Knowledge LevelThinking SkillOutcome
ConceptualUnderstandUnderstand the importance of pharmaceutical development within the regulatory framework.
ProceduralApplyUnderstand the application of GMP and GDP to drug manufacture and distribution.
ProceduralUnderstandUnderstand the role and importance of the pharmacopoeias (BP, EP and USP).

Oral Presentation: Group

Assessment Type Summative Weighting 50
Assessment Weeks 17 Feedback Weeks 17

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Feedback

Maximum group size of 4. Marked on presentation, questions & peer assessment so that each student gets a unique grade.

feedback will be written & in person

 

Learning Outcomes
Knowledge LevelThinking SkillOutcome
ConceptualUnderstandUnderstand the importance of pharmaceutical development within the regulatory framework.
ProceduralApplyUnderstand the application of GMP and GDP to drug manufacture and distribution.
ProceduralUnderstandUnderstand the role and importance of the pharmacopoeias (BP, EP and USP).

Formative Assessment

There are no assessments for this course.

Resit Assessments

Oral Presentation: Group

Assessment Type Summative Weighting 50
Assessment Weeks Feedback Weeks

Look up Week Numbers

Feedback

Written & in person

Learning Outcomes
Knowledge LevelThinking SkillOutcome
ConceptualUnderstandUnderstand the importance of pharmaceutical development within the regulatory framework.
ProceduralApplyUnderstand the application of GMP and GDP to drug manufacture and distribution.
ProceduralUnderstandUnderstand the role and importance of the pharmacopoeias (BP, EP and USP).

Exam - Multiple Choice Questions

Assessment Type Summative Weighting 50
Assessment Weeks Feedback Weeks

Look up Week Numbers

Feedback
Learning Outcomes
Knowledge LevelThinking SkillOutcome
ConceptualUnderstandUnderstand the importance of pharmaceutical development within the regulatory framework.
ProceduralApplyUnderstand the application of GMP and GDP to drug manufacture and distribution.
ProceduralUnderstandUnderstand the role and importance of the pharmacopoeias (BP, EP and USP).

Course Learning Outcomes

Knowledge LevelThinking SkillOutcome
ProceduralUnderstandUnderstand the role and importance of the pharmacopoeias (BP, EP and USP).
ProceduralApplyUnderstand the application of GMP and GDP to drug manufacture and distribution.
ConceptualUnderstandUnderstand the importance of pharmaceutical development within the regulatory framework.

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