Management Forum Logo

Presented by
Management Forum

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 thought it was overall a very good course that I would recommend people to take."

26-27 November 2024
+ 14-15 May 2025, 25-26 November 2025 »
from £1099

Need help? Enrol or reserve

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

Download Print Enrol or reserve

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 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.

This seminar is sponsored by

This course forms part of our selection of Animal Health training courses, designed to keep you up to date with the latest regulations surrounding veterinary medicines, animal feeds, and industry best practices.

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

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

Enrol or reserve

This course will cover:

Day 1
Day 2

The regulatory requirements and study planning

Overview of guidelines
Trial compliance & ethical issues
GCP vs GLP compliance
Project planning and timescales
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

Protocol production and approval
Protocol content and special points for inclusion

Data capture considerations

Good Documentation Practice and ALCOA
Data Capture Forms (DCF)
Paper vs electronic data capture
Data verification

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

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

Enrol or reserve

Donna Taylor
Knoell Animal Health

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.

More details

Jenny Webster
Knoell Animal Health

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.

More details

Rachel Anderson
Knoell Animal Health

Rachel 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.

More details

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*

Please contact us for pricing if you are interested in booking 5 or more delegates

26-27 November 2024

Classroom
Rembrandt Hotel
London

08:30-15:30 UK (London)
Timings may be different for each day
Course code 13995
Optional £240/€312/$360 per night

GBP 1,499
EUR 2,149
USD 2,449

Limited places remaining

2 days classroom-based training
Optional accommodation - 2 nights including breakfast, checking in the day before the course
Meet presenters and fellow attendees in person
Lunch and refreshments provided
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

14-15 May 2025

Live online

09:00-15:30 UK (London) (UTC+01)
10:00-16:30 Paris (UTC+02)
04:00-10:30 New York (UTC-04)
Course code 14601

GBP 1,099 1,299
EUR 1,589 1,869
USD 1,817 2,129

Until 09 Apr

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

View basket

Not ready to book yet?

for 7 days, no obligation

25-26 November 2025

Classroom
Rembrandt Hotel
London

08:30-15:30 UK (London)
Timings may be different for each day
Course code 15094
Optional £255/€356/$407 per night

GBP 1,299 1,499
EUR 1,869 2,149
USD 2,137 2,449

Until 21 Oct

2 days classroom-based training
Optional accommodation - 2 nights including breakfast, checking in the day before the course
Meet presenters and fellow attendees in person
Lunch and refreshments provided
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

* 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; and apply only when booking multiple delegates on the same date.

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

I thought it was overall a very good course that I would recommend people to take.

Nov 28 2023

Marte Sønnervik Norway
Clinical Study Coordinator, PHARMAQ

Nov 28 2023

I'm very delighted with the course, the presentation and the speakers.

Cuong Nguyen Germany
Associate Specialist, Clinical Research, MSD Animal Health Innovation GmbH

Nov 28 2023

I really enjoyed the course and Rachel, Jenny and Donna were wonderfully engaging presenter and given us lots of opportunity to ask the questions. The course was mix of theory & few practical exercises. I took away lots of things which I can easily apply at my work .

Kritika Sengar Chauhan Germany
Associate Specialist, Clinical Research, MSD Animal Health Innovation GmbH

Nov 29 2022

Really happy with the content of the webinar I feel like it covered all the necessary topics that I expected to see in the webinar. The presentations were clear and easy to follow. All speakers were very knowledgeable, clear and friendly.

Ellie Casson United Kingdom
Monitor – Veterinary Clinical Studies, knoell Animal Health Ltd.

May 11 2022

Overall, I would recommend the webinar to people who are starting a career in clinical trials as it gives a good overview of all aspects of GCP.

Laure Bidois United Kingdom
Team Leader Pharmaceuticals and Feed Animal Health, knoell Animal Health Limited

May 11 2022

Very clear and interesting. Practical exercises were also great. And the polls during the presentations to include us was also a great idea.

Emmanuelle Carrié France
Clinical research associate, Ceva Animal Health

May 11 2022

It was a well done webinar, the speakers were very competent and experienced. The content was informative, although I knew some of the content it still was presented very interesting.

Helena Metzker Germany
Clinical Research Associate, MSD Animal Health Innovation

May 11 2022

It was a well done webinar, the speakers were very competent and experienced. The content was informative

Helena Metzker Germany
Clinical Research Associate, MSD Animal Health Innovation

Apr 27 2021

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.

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

Apr 3 2019

Interesting, very motivated speakers. Good course.

Karen Roels Belgium
Clinical Trial Manager, Huvepharma NV

May 9 2018

Very good! All presenters were quite knowledgable, very helpful.

Kevin Yount Germany
Regulatory Affairs Manager, Bayer

May 9 2018

All very engaging. Appropriate depth/pace. Concise [and] thorough.

Sophie Nixon United Kingdom
Veterinary Research Manager, Probiotics International Ltd

May 9 2018

Well presented, good pace, good participant involvement, very knowledgeable speakers.

Paul McKiernan Belgium
Auditor, Elanco Animal Health

Feb 22 2017

Very good

Petra Marshall Germany
CRA, Boehringer Ingelheim Vetmedica GmbH

Oct 11 2016

Excellent course

Isabel Fidalgo Carvalho Portugal
Equigerminal

Oct 11 2016

Excellent course

Isabel Fidalgo Carvalho Portugal
Equigerminal

United Kingdom

ADAS UK LIMITED
ADAS UK Ltd
Animal Health and Veterinary Laboratories Agency
Benchmark Animal Health Ltd
Boehringer Ingelheim
Boehringer Ingelheim Ltd
Ceva
Dechra Limited
Fish Vet Group
Fort Dodge Animal Health Ltd UK
INSTITUTE FOR ANIMAL HEALTH
knoell Animal Health Limited
knoell Animal Health Ltd.
Norbrook Laboratories Ltd
Novartis Animal Health UK Ltd
PetMedix Ltd
Pfizer Limited
Probiotics International Ltd
Royal Veterinary College
The Pirbright Institute
Veterinary Laboratories Agency

Germany Germany

Bayer
Bayer Animal Health GmbH
Bayer Pharma AG
BIVRC GmbH & Co. KG
BIVRC GmbH &Co. KG
Boehringer Ingelheim Veterinary Research Center GmbH & Co.KG
Boehringer Ingelheim Veterinary Research Center GmbH &Co. KG
Boehringer Ingelheim Vetmedica GmbH
Elanco Animal Health GmbH
Free University of Berlin, Institute for Parasitology and Tropical veterinary medicine
Klifovet A.G.
Lohmann Animal Health GmbH
MSD AH Innovation GmbH
MSD Animal Health
MSD Animal Health Innovation
MSD Animal Health Innovation GmbH