MSc Advanced Therapy Medicinal Products
Year of entry: 2022
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Course unit details:
Designing and delivering an ATMP clinical trial ¿manufacturing and regulatory complexities
|Unit level||FHEQ level 7 – master's degree or fourth year of an integrated master's degree|
|Teaching period(s)||Full year|
|Offered by||School of Medical Sciences|
|Available as a free choice unit?||No|
Advanced Therapy Medicinal Products (ATMPS) offer promise as treatments for previously untreatable and high-burden diseases and significant investment has been made globally in order to continue to drive forward the fast paced development of these exciting new treatments.
This module will enable you to develop an understanding of the broad ATMP landscape, pathways and key stakeholders, reflecting on commercial and non-commercial trials to enable successful navigation of this complex environment. You will understanding the GMP requirements and functional practices involved in the manufacturing of ATMP treatments, use of raw materials (excipients) and associated tasks including assay development and the need for new governance structures to review ATMP treatments. You will understand the importance and relevance of the Good Manufacturing Practice (GMP) regulatory framework including specials. You will gain an understanding of Good Clinical Practice (GCP) regulatory requirements and functional practices involved in the design and development of ATMP treatments in clinical trials, This will encompass; roles and functions; need for risk assessment, Standard Operating Procedures (SOPs) and the ethical approval (HRA or Special) process. Furthermore you will undertake an exploration of the complex relationships, requirements and expectations of the MHRA, HTA and other organisations involved in the ATMP regulatory landscape. This will provide insight into the requirements needed to take an ATMP clinical trial from protocol design through regulatory approval in order to bring the newest ATMPs treatments to patients as quickly as possible.
- Analyse the relationships between the appropriate ATMP governing bodies to demonstrate a critical understanding of the complexities of the ATMP regulatory landscape and apply this in relation to developing an ATMP clinical trial protocol.
- Synthesis and discuss the ATMP specific legislation in relation to GCP and GMP in the context of applying for regulatory approvals of an ATMP clinical trial.
- Process complex scientific information to present in lay terms. This will be demonstrated through the development of a clinical trial patient information sheet which must be written in plain language and formatted as per ethical and regulatory approval processes.
- Evaluate and apply all aspects of an ATMP clinical trial design including: (Developing a hypothesis, critical literature review, understanding of application of GCP and GMP, statistical information, study methodologies, endpoints and objectives, ethical considerations and legal and governance considerations ) using a clinical trial template.
Teaching and learning methods
Teaching on this course will be delivered by expert specialists and supported by academic staff from the University of Manchester and clinical experts allocated from an appropriate workplace/academic background. Some PhD students and post-doctoral research fellows will contribute to teaching where appropriate. In addition, opportunities for team-based learning will be provided.
This module offers the opportunity to engage with sessions led by internal and external experts. Learning will be integrally linked to course materials, group discussion and an interactive workshop. There will be opportunities for independent and group work. The course contains elements of self-assessment and peer and lecturer feedback.
|Project output (not diss/n)||30%|
Feedback to students will be made through Turnitin.
|Independent study hours|
|Michelle Davies||Unit coordinator|