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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.

★★★★★ "Overall, I would recommend the webinar to people who are starting a career in clinical trials as it ... more"

29-30 Nov 2022 + 3 more dates

Need help?  Enrol or reserve

  • 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

Enrol or reserve

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

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

Enrol or reserve

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/Classroom 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*

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

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

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Not ready to book yet?

for 7 days, no obligation

2-3 Mar 2023

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 12153

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

Until 26 Jan

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Not ready to book yet?

for 7 days, no obligation

17-18 Jul 2023

Classroom
Rembrandt Hotel
London

09:00-17:00 UK (London)
Course code 12239

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

Until 12 Jun

  • 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

View basket 

 
Not ready to book yet?

for 7 days, no obligation

27-30 Nov 2023

Live online

13:30-16:45 UK (London) (UTC+00)
14:30-17:45 Paris (UTC+01)
08:30-11:45 New York (UTC-05)
Course code 12446

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

Until 23 Oct

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.

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


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.

May 11 2022

Laure Bidois
Senior Advisor Regulatory Affairs, knoell

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
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
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
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
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

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
  • Fish Vet Group
  • Fort Dodge Animal Health Ltd UK
  • INSTITUTE FOR ANIMAL HEALTH
  • knoell
  • Norbrook Laboratories Ltd
  • Novartis Animal Health UK Ltd
  • Pfizer Limited
  • Probiotics International Ltd
  • Royal Veterinary College
  • The Pirbright Institute
  • Veterinary Laboratories Agency

Norway

  • EWOS Innovation
  • Intervet Norbio AS
  • MSD Animal Health Innovation
  • 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

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

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.

Israel

  • Phibro Animal Health

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

Enrol or reserve

Run Practical Implementation of GCP in Veterinary Field Studies Live online/Classroom for your team

2 days

Typical duration

Pricing from:

  • GBP 800
  • Per attendee
  • Course tailored to your requirements
  • At your choice of location, or online

 

We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.

Contact our in-house training expert Aleksandra Beer to discuss your requirements:

Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, 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