Course description
Clinical Trials
The course comprises a series of presentations and workshops, supplemented with distance learning activities. You’ll cover:
- GCP/GMP legislation (including preparation for inspection)
- clinical trial set-up and management
- manufacture of IMPs and QP release
- clinical trials in specialist areas.
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Suitability - Who should attend?
Who should attend?
The course is suitable if you have general or specialist experience in clinical trials. Please note that this course is not aimed at absolute beginners, we recommend attending the course when you have 6-12 months’ experience in the field. We also recommend that in preparation for the course, delegates read the MHRA Good Clinical Practice Guide. The section listing abbreviations is particularly useful.
Outcome / Qualification etc.
How will I benefit?
This course will give you an opportunity to develop and update your knowledge and skills, and gain experience on a variety of aspects of Good Clinical Practice relating particularly to the conduct of clinical trials.
Training Course Content
Day 1
- Clinical trials in the UK – an overview
- National Pharmacy Clinical Trials Advisory Group
- Performance management
- Regulatory update
- MHRA inspection preparation
- MHRA inspection prepraration –audit tool workshop
- Importation of clinical trials
Day 2
- Clinical trial set-up
- Clinical trials set-up workshop
- Costingpharmacy resource for clinical trials
- Trial management, accountability and pharmacovigilence (workshop)
- Manufacture ofIMPs GMP vs GCP
- Role of the QP
Day 3
- IMPs vs nIMPS (Auxiliary IMPs)
- Advanced Therapy Medicinal Products (ATMP)
- Advanced Therapy Medicinal Products (ATMP) workshop
- Clinical trials in radiopharmacy
- Clinical trials in paediatrics
- Clinical trials in oncology and haematology
- Work of the HRA and Pharmacy Assurance