Presented by
Management Forum

Practical Implementation of GCP in Veterinary Field Studies

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.

28-29 Apr 2022 + 2 more dates

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

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:

The Regulatory Requirements and Study Design

  • Overview of GCP status covering VICH guidelines
  • An indication where trials must comply
  • Ethical aspects of GCP in all studies
  • Field study vs laboratory studies – regulatory GCP and GLP compliance
  • European anomalies
  • Project planning and timescales
  • Types of trials
  • Project design and teamwork
  • A case study

Protocol Design and Application

  • Protocol production and approval
  • Protocol content and special points for inclusion
  • A case study

Setting up Clinical Trials – A Practical Case Study

  • Case report form design and supportive documentation
  • Investigator selection
  • Responsibilities of the monitor and the principal investigator
  • Test material
  • In-life activities
  • Study close-out and reporting
  • Principal differences between laboratory and field studies

Data considerations

  • Trial master files
  • Paper vs electronic data capture
  • ALCOA
  • Data verification
  • Blind case review and evaluable cases
  • Submission of data to regulators

Data handling and ‘appropriate’ statistics

  • Review of the current CVMP statistics guidelines
  • Types of data
  • Types of statistics
  • Evaluation of data
  • Work group illustrated examples

Producing the FSR

  • FSR format and authorship
  • Appendices and data inclusions
  • Amending the FSR
  • Archiving the study

Assuring quality in VICH GCP studies

  • Standard operating procedures (SOPs) writing, use and review
  • Sponsor’s responsibilities for quality of the study
  • QA vs QC
  • The QA function
  • The monitoring function
  • Confirming compliance

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Julian Braidwood

Julian Braidwood qualified as a Veterinary Surgeon and worked in mixed practices before spending fifteen years in R&D and Regulatory departments of five leading Animal Health companies. Julian has managed clinical trials and regulatory groups, experimental facilities, laboratories, and worked internationally in many countries. Having become an R&D Director within the industry, he co-founded Triveritas in 2,000 which grew rapidly internationally and became part of knoell in 2021. knoell is one of the leading service providers for worldwide registration and regulatory compliance in crop protection, crop nutrition, chemicals, cosmetics, animal health products, and medical devices. The knoell Group employs almost 600 people worldwide in more than 14 countries.

knoell is the only knowledge-based animal health consultancy and clinical studies specialist with its own technical staff based on three continents: North America, Europe, and Asia. The animal health team offers a full portfolio of services, including start-to-finish product development and ad hoc services – in all domesticated species for pharmaceuticals and biologicals, feed additives, novel, generic and borderline products.

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Marie-Pascale Tiberghien

Marie-Pascale qualified from Lyon Veterinary School, France. She holds an MSc in Applied Statistics from Sheffield Hallam University, 1997. She has worked in the veterinary pharmaceutical industry for most of her career, in Britain, France and Germany. Her focus includes notably Clinical Development – She has been a Study Director as well as a Monitor - and Marketing and Technical Services. Previously with Merial and then Bayer, she has been an independent consultant to the Animal Health industry for more than 8 years. She is passionate about the appropriate use of Statistics.

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

28-29 Apr 2022

Live online

09:15-17:00 UK (London) (UTC+01)
10:15-18:00 Paris (UTC+02)
04:15-12:00 New York (UTC-04)
Course code 11608

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

Until 24 Mar

In your basket 

30 Jun-1 Jul 2022

Classroom
London venue TBC

09:00-17:00 UK (London)
Course code 11416

  • GBP 1,199 1,399
  • EUR 1,679 1,959
  • USD 1,870 2,182

Until 26 May

  • 2 days classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy

In your basket 

20-21 Oct 2022

Live online

09:00-17:00 UK (London) (UTC+01)
10:00-18:00 Paris (UTC+02)
04:00-12:00 New York (UTC-04)
Course code 11739

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

Until 15 Sep

In your basket 

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
Advisor Brand Maximization, Elanco New Zealand

Oct 27 2020

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

Audur Thorisdottir
Study Director, VESO Vikan

Oct 27 2020

Really informative.

Christina Schøier
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
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
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
Scientist, Ceva-Phylaxia Co Ltd

Apr 3 2019

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

Nina Beck Toubro
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
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
Clinical Research Coordinator, Bioceltix

Apr 3 2019

Very pleasant people (all). All was OK

Daniel Zeller
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
Director: Biological and Infectious Diseases, Scientific Operations, Clinglobal

Apr 3 2019

Interesting, very motivated speakers. Good course.

Karen Roels
Clinical Trial Manager, Huvepharma NV

May 9 2018

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

Kevin Yount
Regulatory Affairs Manager, Bayer

May 9 2018

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

Sophie Nixon
Veterinary Research Manager, Probiotics International Ltd

May 9 2018

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

Paul McKiernan
Auditor, Elanco Animal Health

Feb 22 2017

Very good

Petra Marshall
CRA, Boehringer Ingelheim Vetmedica GmbH

Oct 11 2016

Excellent course

Isabel Fidalgo Carvalho
Equigerminal

Oct 11 2016

Excellent course

Isabel Fidalgo Carvalho
Equigerminal

UK

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

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
  • Klifovet A.G.
  • Lohmann Animal Health GmbH
  • MSD AH Innovation GmbH
  • MSD Animal Health Innovation
  • MSD Animal Health Innovation GmbH

Norway

  • EWOS Innovation
  • Intervet Norbio AS
  • MSD Animal health Norge
  • MSD Animal Health Norge AS
  • PHARMAQ
  • Pharmaq AS
  • Pharmaq AS part of Zoetis
  • PHARMAQ Zoetis
  • ScanVacc AS
  • STIM AS
  • Val FoU/ Pharmaq
  • VESO Vikan
  • Veso Vikan Akvavet

Belgium

  • Aratana Therapeutics NV
  • Delaval NV
  • Elanco Animal Health
  • Federal Agency for Medicine & Health Products
  • Huvepharma NV
  • Merck Sharp Dohme (Europe) Inc.
  • Nutriad International BV
  • Poulpharm
  • State University of Ghent
  • Universite Libre de Bruxelles
  • Veterinary and Agrochemical Research Centre

Netherlands

  • DADA Consultancy
  • Dechra
  • Dechra Veterinary Products
  • Nutreco Nederland BV
  • Regivet BV
  • Trouw Nutrition R&D
  • Vaxxinova Nederland BV

Denmark

  • Boehringer-Ingelheim Danmark A/S
  • Pharmacosmos
  • Pharmacosmos A/S
  • SEGES
  • University Hospital of Companion Animals, University of Copenhagen, SUND

France

  • CEVA
  • Ceva Animal Health
  • CEVA Sante Animale
  • Intervet
  • Merial SAS

Ireland

  • Bimeda
  • Chanelle Pharmaceutical Manufacturing Ltd.
  • EirGen Pharma Ltd
  • Tonisity International

Finland

  • Orion Corporation Orion Pharma
  • Vetcare Ltd
  • Vetcare Oy

Hungary

  • Ceva Phylaxia Co Ltd
  • Ceva-Phylaxia Co Ltd
  • Ceva-Phylaxia Co. Ltd.

Spain

  • C Z Veterinaria S.A.
  • Ecuphar Veterinaria S.L.U.
  • Ecuphar Veterinaria SLU

Czech Republic

  • Dyntec s.r.o.
  • Dyntec, ltd.

New Zealand

  • Elanco New Zealand
  • Intuit Regulatory and Marketing Limited

Poland

  • Bioceltix
  • Vetoquinol Biowet Sp zoo

Switzerland

  • DR. E. GRAEUB AG
  • Elanco Animal Health

Australia

  • Anatara Lifesciences

Austria

  • MED-EL Medical Electronics

Canada

  • Triveritas

Croatia

  • Genera

Greece

  • Alapis S.A.

Italy

  • Prof Gianfranco Piva

Mauritius

  • Clinglobal

Peru

  • Agrovet Market

Portugal

  • Equigerminal

Serbia

  • Medicines and Medical Devices Agency of Serbia

Slovenia

  • Billev farmacija vzhod d.o.o

Uganda

  • National Drug Authority

United States of America

  • Novartis Animal Health US Inc

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Multiple colleagues?
Talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra BEER
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy