Last modified: 21 Oct 2022 14:30
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.
| Study Type | Postgraduate | Level | 5 |
|---|---|---|---|
| Term | First Term | Credit Points | 15 credits (7.5 ECTS credits) |
| Campus | Aberdeen | Sustained Study | No |
| Co-ordinators |
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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.
Information on contact teaching time is available from the course guide.
| Assessment Type | Summative | Weighting | 50 | |
|---|---|---|---|---|
| Assessment Weeks | 17 | Feedback Weeks | 17 | |
| 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
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| Knowledge Level | Thinking Skill | Outcome |
|---|---|---|
| Conceptual | Understand | Understand the importance of pharmaceutical development within the regulatory framework. |
| Procedural | Apply | Understand the application of GMP and GDP to drug manufacture and distribution. |
| Procedural | Understand | Understand the role and importance of the pharmacopoeias (BP, EP and USP). |
| Assessment Type | Summative | Weighting | 50 | |
|---|---|---|---|---|
| Assessment Weeks | Feedback Weeks | |||
| Feedback |
30 multiple choice questions |
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| Knowledge Level | Thinking Skill | Outcome |
|---|---|---|
| Conceptual | Understand | Understand the importance of pharmaceutical development within the regulatory framework. |
| Procedural | Apply | Understand the application of GMP and GDP to drug manufacture and distribution. |
| Procedural | Understand | Understand the role and importance of the pharmacopoeias (BP, EP and USP). |
There are no assessments for this course.
| Assessment Type | Summative | Weighting | 100 | |
|---|---|---|---|---|
| Assessment Weeks | Feedback Weeks | |||
| Feedback | ||||
| Knowledge Level | Thinking Skill | Outcome |
|---|---|---|
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| Knowledge Level | Thinking Skill | Outcome |
|---|---|---|
| Conceptual | Understand | Understand the importance of pharmaceutical development within the regulatory framework. |
| Procedural | Understand | Understand the role and importance of the pharmacopoeias (BP, EP and USP). |
| Procedural | Apply | Understand the application of GMP and GDP to drug manufacture and distribution. |
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