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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.

★★★★★ "I found the details provided in the webinar and the additional resources/notes were very comprehensi... more"

29-30 Nov 2022

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Format: Live online
CPD: 12 hours for your records
Certificate of completion

Practical Implementation of GCP in Veterinary Field Studies

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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

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The Practical Implementation of GCP in Veterinary Field Studies course will cover:

Day 1
Day 2

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

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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 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.

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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.

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Tamsin Dawson

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.

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Book Practical Implementation of GCP in Veterinary Field Studies Live online training

NEW higher discounts for multiple bookings - 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*

29-30 Nov 2022

Live online

09:00-15:30 UK (London) (UTC+00)
10:00-16:30 Paris (UTC+01)
04:00-10:30 New York (UTC-05)
Course code 11739

GBP 999 1,199
EUR 1,439 1,719
USD 1,630 1,942

Until 25 Oct

2 days live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

Online registration unavailable: this date is nearing full capacity; please contact us to register.

* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price.

Reviews of IPI's Practical Implementation of GCP in Veterinary Field Studies training course

I found the details provided in the webinar and the additional resources/notes were very comprehensive. I enjoyed that there were multiple speakers/subject matter experts for specific areas in GCP planning to allow for better understanding of the key stakeholders in the planning process. The speakers were very informative and topics discussed were very relevant. The transition between topics kept attendees engaged for the entire time.

Apr 27 2021

Abigail Harwood New Zealand
Advisor Brand Maximization, Elanco New Zealand

Oct 27 2020

Good speakers. Too much content given the period of time.

Audur Thorisdottir Norway
Study Director, VESO Vikan

Oct 27 2020

Really informative.

Christina Schøier Denmark
Senior veterinarian, University Hospital of Companion Animals, University of Copenhagen, SUND

Oct 23 2019

Well-organized course, great presenters – the course equipped me with all the information I was looking for. The speakers gave good presentations, with great examples from real-life, and I particularly liked the workshop and tips for design of clinical trials.

Lea Heuer Germany
Clinical Research Manager, MSD Animal Health Innovation GmbH

Oct 23 2019

Well organized and useful. I was hoping that this course would help me in my daily work with GCP field studies and my expectations were met.

Viktória Czibula Hungary
Scientist, Ceva-Phylaxia Co Ltd

Oct 23 2019

I was hoping to achieve comprehensive, up-to-date and practical knowledge of the organization, conduct and regulatory environment of GCP-compliant veterinary studies from front-rank experts/trainers and I think I have accomplished it via a very user-friendly, enjoyable yet most professional course in the bright, interactive company of fellow attendees and trainers. The course was excellent, I will recommend it to my colleagues and will also implement some new ideas in the routine work (e.g. SOPs) of my team related to GCP-compliant clinical studies.

Albert Tóth Hungary
Scientist, Ceva-Phylaxia Co Ltd

Apr 3 2019

Good training course that I can implement to my daily work immediately.

Nina Beck Toubro Denmark
QA Director, Pharmacosmos

Oct 23 2019

The presenters delivered the course material in a clear and structured manner. They were knowledgeable about the topic and any related issues and answered questions effectively. I particularly liked the practical examples.

Dirk Schmidt Germany
Senior Project Leader, Boehringer Ingelheim Vetmedica GmbH

Oct 23 2019

An intensive course with a lot of detailed and professional information. Lectures were conducted in a clear and understandable way and all the speakers were very professional, with wide knowledge, and were willing to answer all the questions.

Marta Pasikowska Poland
Clinical Research Coordinator, Bioceltix

Apr 3 2019

Very pleasant people (all). All was OK

Daniel Zeller Czech Republic
Head of Clinical Trials and Biological Testing of Veterinary Products, Dyntec, ltd.

Apr 3 2019

A very interesting course to get a good overview of all the aspects to perform veterinary field studies under GCP conditions. The presenters were all very enthusiastic about their topics and were really facilitating interesting discussions throughout the course.

Maxime Madder Mauritius
Director: Biological and Infectious Diseases, Scientific Operations, Clinglobal