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Practical Implementation of GCP (Good Clinical Practice) in Veterinary Field Studies Training Course
This seminar will take many aspects of animal health and veterinary research and development through a typical clinical trial, and pay attention to compliance with Good Clinical Practice (GCP) as outlined in the two guidelines on safety and efficacy produced by FEDESA and the CVMP.
29-30 Nov 2022
Details
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 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 challenging case studies 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
This seminar is sponsored by
Who should attend
- Personnel involved in the animal health industry who are responsible for monitoring clinical veterinary studies and setting up protocols and studies, both in laboratory and field environments, to comply 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, the regulatory requirements and European perspectives
Programme
The Regulatory Requirements and Study Design
- Overview of Guidelines
- Trial compliance & ethical issues
- GCP vs GLP compliance
- Project planning and timescales
- Types of studies
- Effective Design and Delivery
Assuring Quality in Clinical Studies
- Sponsor’s responsibilities
- Quality Assurance vs Quality Control
- Quality Assurance involvement
- The Monitor’s involvement
- The role of Standard operating procedures and examples
Protocol Design and Application
- Protocol production and approval
- Protocol content and special points for inclusion
- Data Capture Forms
Data Considerations
- Clinical study files
- Paper vs electronic data capture
- ALCOA
- Data verification
- DCF Workshop
Statistical Considerations
- Role of Statistics in Clinical Study Design
- Regulatory Guidelines
- Types of Data
- Study Designs
- Descriptive Statistics
- Statistical Tests for Supporting Claims
- ‘Per Protocol’ Vs ‘Intent to Treat’
- Planning Sample Sizes
- Protocol Writing, including Statistical Plan
Setting up Clinical Studies
- Responsibilities of the Sponsor, Monitor, and Investigator
- Investigational Veterinary Product (IVP) and Control Product (CP)
- Investigator selection
- Study set-up
- In-phase monitoring
- Study close-out
The Final Study Report
- Authorship and responsibilities
- Contents of Final Study Report
- Some practical considerations
A Practical Case Study
Presenters
Donna Taylor (More...)
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 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.
Jenny Webster (More...)
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.
Tamsin Dawson (More...)
Dr Tamsin Dawson has worked in animal health product development and registration since 2005 and started her career in industry in an analytical method development & validation role. In her current position as project manager at knoell, Tamsin support clients on a range of veterinary vaccine/biologicals and feed additive product developments and registrations. This includes assessing data suitability for European applications (quality, safety & efficacy) and providing strategic regulatory advice and practical regulatory support such as dossier writing and managing regulatory procedures. Tamsin also advises on appropriate study designs and statistical considerations for the conduct of target animal studies.
Book now
Book now
NEW higher discounts for booking multiple places - bring your colleagues to make your training budget go further:
- 30% off the 2nd delegate
- 40% off the 3rd delegate
- 50% off the 4th delegate
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29-30 Nov 2022 Live webinar 09:00-15:30 UK (London) |
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29-30 Nov 2022 Live webinar 09:00-15:30 UK (London) |
GBP 1,199 999 EUR 1,719 1,439 USD 1,942 1,630 Until 25 Oct* |
Online registration unavailable: this date is nearing full capacity; please contact us to register. |
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* Note the early booking discount cannot be combined with any other offers or promotional code. As such, discounts for the 2nd/3rd/4th attendees are based on the full price of the course. Please contact us for pricing if you wish to send more than 4 delegates.