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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.

26-27 November 2024 »
from £1299

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

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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 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.

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

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.

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

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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

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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.

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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.

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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.

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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)
Course code 13995
Optional £240/€312/$360 per night

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

Until 22 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

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* 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.

Previous customers

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 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