Course overview
This two-day course will provide a comprehensive overview and suggest practical approaches to the design, set-up and conduct of veterinary clinical trials in compliance with VICH good clinical practice (GCP) principles.
The programme will address the responsibilities of all study roles, required documentation and data handling processes. Sessions will also explore the appropriate quality standards to be applied to warrant data that is acceptable to regulators in the EU and USA.
Delegates will be expected to work through solutions to a number of activities, including an example case study which will help consolidate learning. There will also be ample opportunity for discussion with the expert faculty who all have considerable experience in this field.
CPD Hours: 12
Course Content
- Day 1
- Regulatory requirements
- Managing clinical studies
- Protocol design
- Data capture considerations
- Data lifestyle workshop
- DCF workshop
- Monitoring & data management
- Statistical considerations
- Assuring quality in clinical studies
- The Final Study Report
- A practical case study
Speakers
Donna Taylor
Donna is a University of Birmingham graduate with an honours degree in Biochemistry that included an industrial placement year at Celltech R&D, Slough (now UCB). Post-degree, Donna returned to Celltech as a Downstream Process Development Scientist in a GLP compliant facility. Joining Moredun Research Institute, Edinburgh, in 2004 as a Senior Research Assistant in veterinary immunology gave valuable experience across the disciplines of virology, bacteriology and parasitology leading to a move into monitoring veterinary Clinical Trials at Charles River Laboratories, Cumbria. From 2008 Donna was in the post of Trainee Project Leader, conducting both VICH GCP and GLP studies in a variety of species. As a direct result of site closure Donna took a position of Trial Co-ordinator at the University of Manchester operating a large phase III multi-centre study to GCP in the human field. In 2010, Donna returned to Cumbria and back to animal health for a position within Quality Assurance at Triveritas Ltd, acquired by Knoell in 2020, auditing not only VICH GCP and GLP studies conducted worldwide, but also aspects of GMP and 21CFR11 compliance in product development. Donna is also a member of the Research Quality Association and did reside on the Animal and Veterinary Product Committee.
Jenny Webster
Jenny Webster began her role as Monitor of Veterinary Clinical Studies in 2013. Prior to that she was a Registered Veterinary Nurse (RVN) working in clinical practice in the UK. Jenny has actively monitored a range of GCPv studies in companion and food producing animals and is also responsible for study design, protocol preparation and reporting of completed studies. She also acts in the role of Sponsor Representative for pre-clinical studies and is involved with authoring and reviewing clinical study protocols and final study reports.
