Management Forum courses now available at IPI Academy - visit IPI for an updated experience and a broader selection of courses and subjects

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

Book now

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
29-30 Nov 2022
Live webinar
09:00-15:30
UK (London)
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.

Learn more about our face-to-face and webinar training formats.

* 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.

Continuing professional development

This course qualifies for 12 hours for your CPD records.
More about CPD

Customised in-house training

We can customise this course to meet the requirements of your organisation and deliver it at your location and/or online.

Contact us

You may also be interested in

Previous customers include...

  • ADAS UK Ltd
  • Bimeda
  • Bioceltix
  • BIVRC GmbH & Co. KG
  • Boehringer Ingelheim Ltd
  • Boehringer Ingelheim Vetmedica GmbH
  • Dechra
  • Delaval NV
  • DR. E. GRAEUB AG
  • Dyntec s.r.o.
  • Ecuphar Veterinaria SLU
  • EirGen Pharma Ltd
  • Elanco New Zealand
  • Federal Agency for Medicine & Health Products
  • Genera
  • Intuit Regulatory and Marketing Limited
  • knoell Animal Health Ltd
  • Lohmann Animal Health GmbH
  • Norbrook Laboratories Ltd
  • Pfizer Limited
  • Pharmacosmos
  • Pharmacosmos A/S
  • PHARMAQ
  • Poulpharm
  • Royal Veterinary College
  • STIM AS
  • The Pirbright Institute
  • Trouw Nutrition R&D
  • Vetcare Ltd
  • Vetoquinol Biowet Sp zoo

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 , May 22

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, Senior Advisor Regulatory Affairs, knoell, May 22

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, Apr 21

Really informative.

Christina Schøier, Senior veterinarian, University Hospital of Companion Animals, University of Copenhagen, SUND, Oct 20

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

Audur Thorisdottir, Study Director, VESO Vikan, Oct 20

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, Oct 19

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 19

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 19

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, Oct 19

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 19

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

Nina Beck Toubro, QA Director, Pharmacosmos, Apr 19

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 19

Interesting, very motivated speakers. Good course.

Karen Roels, Clinical Trial Manager, Huvepharma NV, Apr 19

Very pleasant people (all). All was OK

Daniel Zeller, Head of Clinical Trials and Biological Testing of Veterinary Products, Dyntec, ltd., Apr 19

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

Sophie Nixon, Veterinary Research Manager, Probiotics International Ltd, May 18