MSc Pharmaceutical Industrial Advanced Training (PIAT) / Course details
Year of entry: 2020
Course unit details:
Research & Development and Manufacturing (PLG 8)
|Unit level||FHEQ level 7 – master's degree or fourth year of an integrated master's degree|
|Teaching period(s)||Variable teaching patterns|
|Available as a free choice unit?||No|
This unit covers the business development issues arising from both the R&D and manufacturing areas of operation. This includes a review of the business development deals from research alliances, supply agreements and outsourcing.
- To develop an awareness of the development process for pharmaceutical products with an emphasis on the key issues that are relevant to the negotiation and implementation of licensing and business development deals.
- To understand the resources and operational metrics and norms that apply within companies and the standards that are required to ensure the safe development of new products.
- To understand the manufacturing and logistical issues that has an impact on the supply of pharmaceutical products.
- To understand the impact of the foregoing on business development deals and the success of pharmaceutical companies.
- To develop an appreciation of the scientific rationale underpinning the different processes and how the results are interpreted.
- To understand and explain the business rationale and key components of the various agreements that are developed to manage and control deals relating to R&D, manufacture and QC
- To have sufficient understanding of the elements of each of the processes and results for R&D, manufacturing and QA/QC to identify the key issues that have to be resolved.
- To demonstrate an ability to understand and summarise the information in order to critically appraise the key issues and provide suggestions how these issues may be dealt with in an agreement
- To be able to explain to a general audience the nature of the R&D, manufacturing and/or QA/QC project, the key issues and how these may be solved
- To be able to communicate to a technical or scientific audience how the terms of their agreements may affect their area of expertise and to discuss and agree with them how the key issues and obligations could be dealt with in an agreement.
- To be able to explain to the legal team how the R&D, manufacturing and QA/QC project and issues may be dealt with in an agreement.
|Written assignment (inc essay)||100%|
Provisional marks and feedback for coursework returned within 15 working days.
Exam marks and final marks returned after ratification at exam board.
|Independent study hours|
|Matthew Shaw||Unit coordinator|