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 and other regulatory guidelines.
The programme will address the responsibilities of all study roles, required documentation, data handling processes and statistical analysis. 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.
Benefits of attending
- Understand the regulatory requirements and study design
- Know how to compile compliant protocols
- Take away practical advice on how to set up clinical studies
- Learn how to practically conduct and manage compliant clinical studies
- Clarify specific aspects of clinical studies
- Gain a better understanding of data and ‘appropriate’ statistics
- Discover how to produce a compliant final study report (FSR)
- Assure the quality of clinical studies
Certifications:
- CPD: 12 hours for your records
- Certificate of completion
Speakers
Jenny Webster,
Monitor of Veterinary Clinical StudiesJenny 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.
Rachel Anderson,
Knoell Animal HealthRachel is a University of Aberdeen graduate with an honours degree in Pharmacology and a Masters degree in Drug Discovery and Development. Post-degree, Rachel joined Charles River Laboratories, Edinburgh as a Scientist in GLP Animal Health studies, before becoming a Study Director in GLP pre-clinical studies in food producing animals. While working as a Study Director at Charles River Laboratories, this led to a move into monitoring veterinary Clinical Trials in both companion and food producing animals. In 2023 Rachel joined the team at knoell Animal Health as a Project Manager in Animal Health studies.
Donna Taylor,
Moredun Research InstituteDonna 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 to 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.
Who Should Attend
- Personnel involved in the animal health industry who are responsible for monitoring veterinary clinical studies conducted in the field in compliance with, GCP
- Personnel involved in the set-up and coordination of clinical studies
- Personnel responsible for authoring Protocols and Final Study Reports for studies that are to be conducted in the field in compliance with GCP
- Quality assurance professionals who are required to audit these types of studies
- Clinical project managers and regulatory affairs personnel who will benefit by gaining an overview of the conduct of studies and the regulatory requirements
