Course description
Regulatory Control of Clinical Operations
Lectures and workshops will cover the understanding and application of modern approaches and understanding of regulatory requirements for carrying out clinical research, including the latest requirements for IMPD preparation and good distribution practice, ethical and regulatory approval, clinical trials with medical devices and ISO14155, good clinical practice standards, preparation of clinical trial reports, the more demanding requirements of pharmacovigilance and also the legal aspects relevant to clinical trials such as data protection, insurance and codes of practice.
The use of case studies and workshops will assist in the achievement of these learning outcomes and enable the students to contextualise their understanding and knowledge.
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Suitability - Who should attend?
Suitable for
- Students of the MSc programme
- participants from the regulatory affairs industry who wish to develop their knowledge of clinical operations
- participants from allied industries who wish to have a comprehensive understanding of the subject
Outcome / Qualification etc.
Benefits to participants
- Students will understand the practical aspects of Good Clinical Practice and how it supports clinical research.
- Students will be able to identify the regulatory requirements for clinical research in major markets, understand the importance of the EU Clinical Trial Directive and the requirements and practicalities of preparing the required clinical trial applications and associated documentation.
- Students will gain an insight into the complexities and requirements of pharmacovigilance in clinical research.
- Students will be able to understand the management of clinical trial supplies.
- Students will be able to understand the requirements of Good Manufacturing Practice, authorisation and importation of investigational medicinal products.
- Students will be able to understand clinical trial reporting, the management of the data, data auditing and the practicalities of Good Clinical Practice inspections.
- Students will gain an appreciation of the legal and ethical aspects of clinical research, including insurance, indemnity and the role of the ethics committees and safety boards.
Expenses
The full tuition price for students is 1500 GBP. The price for participants is 1700 GBP