Clinical Trials

This course is available for NHS delegates only. 

The Clinical Trials short course has been developed by NHS TSET (the Technical Specialist Education and Training group) and is facilitated by the University of Leeds.

For more information about TSET, visit their website.

What will I learn?
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

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.

This course is available for NHS delegates only, working within pharmacy services.

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.

Day one

Registration: 08:30 – 09:00

• Clinical trials in the UK – an overview

• National Pharmacy Clinical Trials Advisory Group

• Day in the life of a Clinical Trials Team 

• Hot Topic - Advanced Therapy Medicinal Products (ATMP)

  • Advanced Therapy Medicinal Products (ATMP) Workshop

  • Point of Care Manufacture

  • Performance management

  • Importation of clinical trials (In person delivery)

Day two

• Clinical trial set-up

• Clinical trials set-up workshop

• Costing pharmacy resource for clinical trials

• Trial management, accountability and pharmacovigilence (workshop)

• Manufacture of IMPs GMP vs GCP

• Role of the QP

Day three

• IMPs vs nIMPS (Auxiliary IMPs)

• Clinical trials in radiopharmacy 

• Clinical trials in paediatrics

• MHRA Regulatory update 

• Preparation for inspection 

• Questions Time & Ask the Inspector

• Work of the HRA and Pharmacy Assurance (In person delivery)

Course ends: 15:30*

*Please plan your travel to attend the full course, ensuring you stay through to the end to capture key takeaways and maximise your learning experience. 

Course Director
Lynn Morrison - Regional Quality Assurance Pharmacist, NHS Greater Glasgow and Clyde

Speakers
Kam Ajimal, GCP Inspector, MHRA
Anne Black, Regional Quality Assurance Specialist Pharmacist, 
Newcastle-upon-Tyne Hospitals NHS Foundation Trust
Joanna Cantle, Training Consultant – Clinical Trials
Margaret Cooper, School of Biomedical Engineering and Imaging Sciences, King’s College London
Elizabeth Douglas, Senior Clinical Trials Pharmacist, NHS GG&C 
Phillip Good, Start Up Manager, NIHR Clinical Research Network
Kay Pollock, Head of Radiopharmacy, NHS GG&C 
Anoushka Tepielow, Senior Technical Assurance Officer, Health Research Authority
Mandy Wan, Lead Paediatric Research Pharmacist, Evelina London Children’s Hospital  
Trevor Watson, Lead Senior GMDP Inspector, MHRA
Penny Williams, Research Delivery Manager, NIHR (National Institute for Health and Care Research) 

This course is available for NHS delegates only, please note that this year we have introduced a cap of 3 delegates per Trust/organisation.

Course fee: £TBC

Fees are VAT exempt

Fees include:

• cost of tuition

• course materials

• lunches

• light refreshments

View our terms and conditions

The course will take place at Weetwood Hall Estate, which is situated to the north of Leeds at the junction of the A660 Leeds - Skipton road and the A6120 Outer Ring Road.​​

Weetwood Hall Estate
Otley Road
Leeds
West Yorkshire
LS16 5PS
UK

The course will take place at Weetwood Hall Estate, which is situated to the north of Leeds at the junction of the A660 Leeds - Skipton road and the A6120 Outer Ring Road.

If you require accommodation, and wish to stay at the course venue Weetwood Hall Estate please contact Stevie Standerline E: reservations@weetwood.co.uk / T: 0113 230 6000 quoting ‘CPD’ and the ‘Clinical Trials’ course.

Bedrooms are subject to availability with free of charge cancellation 48 hours prior to arrival:
Friday – Sunday – bed and breakfast £TBC
Monday – Thursday – bed and breakfast £TBC
Rates are per night for sole occupancy in a superior double room and inclusive of VAT. 

“Complete and comprehensive teaching overview covering all aspects of clinical trial pharmacy.”
Thomas Sanders, The Clatterbridge Cancer Centre 

“Really informative, so many useful tools and resources have been given to me and I loved this course and being able to talk to people from all different organisations and different trusts.”
Sarah Skinner, Liverpool University Hospitals NHS Foundation Trust

“Amazing course, informative sessions presented by fabulous presenters, excellent venue. I will recommend it to anyone working in clinical trials.”
Joanna Kmita, University College London Hospitals NHS Foundation Trust

“Course presented by friendly, approachable speakers who share a wealth of useful experience and knowledge.”
Kerry Howlett, East Suffolk and North Essex Foundation Trust