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Practical Implementation of GCP 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.

27-28 Oct 2020

& 27-28 Apr 2021 , 29-30 Apr 2021 , 26-27 Oct 2021 , 28-29 Oct 2021

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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 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 (this session includes 2x short breaks)

  • 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

Presenters

Sue Lester (More...)

Sue Lester qualified in Biology and Chemistry and worked in a veterinary laboratory before joining the Animal Health industry where she has now worked for nearly 20 years. She rapidly became a leading international expert in Quality Assurance (GCPv, GLP, and GMP). She has a Diploma in Research Quality Assurance, and is a Fellow of the British Association of Research Quality Assurance (BARQA). She was a founding member of the BARQA Animal Health Committee, and is the author of a chapter on GCPv in the textbook “Veterinary Clinical Trials from Concept to Completion”. Having been employed by four companies Sue was a Founding Director of Triveritas, a leading international contractor to the Animal Health industry. She is responsible for all aspects of Quality Assurance.

Julian Braidwood (More...)

Dr 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. He 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 formed Triveritas in 2000 which has grown rapidly throughout Europe and North America and has offices in UK, France, Germany, Poland and USA. Triveritas provides specialist contract services to Animal Health and related companies. Triveritas develops veterinary vaccines and medicines by providing comprehensive services in veterinary regulatory affairs, regulatory maintenance, international clinical trials, QA, project/study management, and training. A tailored start to finish service takes client projects from proof of concept through to multi-national registrations.

Marie-Pascale Tiberghien (More...)

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, notably in Clinical Development and later in Marketing and Technical Services. Previously with Bayer she is now an independent consultant to the Animal Health industry.

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Book now

27-28 Oct 2020
Live webinar
27-28 Oct 2020
Live webinar
GBP 1,199.00
EUR 1,719.00
USD 1,942.00
+ VAT @ 20.00%
Registration for this event now closed.
27-28 Apr 2021
Live webinar
27-28 Apr 2021
Live webinar
GBP 999.00
EUR 1,439.00
USD 1,630.00
Until 16 Mar 21*
Enrol now
to attend
Live webinar
29-30 Apr 2021
Face-to-face, (venue not yet confirmed)
29-30 Apr 2021
Face-to-face
(venue not yet confirmed)
GBP 1,199.00
EUR 1,679.00
USD 1,870.00
Until 18 Mar 21*
Enrol now
to attend
Face-to-face
(venue not yet confirmed)
  • 2 days of 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
26-27 Oct 2021
Live webinar
26-27 Oct 2021
Live webinar
GBP 999.00
EUR 1,439.00
USD 1,630.00
Until 14 Sep 21*
Enrol now
to attend
Live webinar
28-29 Oct 2021
Face-to-face, (venue not yet confirmed)
28-29 Oct 2021
Face-to-face
(venue not yet confirmed)
GBP 1,199.00
EUR 1,679.00
USD 1,870.00
Until 16 Sep 21*
Enrol now
to attend
Face-to-face
(venue not yet confirmed)
  • 2 days of 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

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

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

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Previous customers include...

  • ADAS UK LIMITED
  • Bayer Pharma AG
  • Benchmark Animal Health Ltd
  • BIVRC GmbH &Co. KG
  • Boehringer Ingelheim Animal Health GmbH
  • Boehringer Ingelheim Vetmedica GmbH
  • Boehringer-Ingelheim Danmark A/S
  • C Z Veterinaria S.A.
  • CEVA
  • Delaval NV
  • Dyntec s.r.o.
  • Ecuphar Veterinaria SLU
  • Equigerminal
  • Federal Agency for Medicine & Health Products
  • Genera
  • MSD Animal Health Norge AS
  • National Drug Authority
  • Novartis Animal Health US Inc
  • OPCA Defi
  • Orion Corporation Orion Pharma
  • PHARMAQ Zoetis
  • Poulpharm
  • Regivet BV
  • ScanVacc AS
  • The Pirbright Institute
  • The Royal Veterinary College
  • University Hospital of Companion Animals, University of Copenhagen, SUND
  • Vetcare Oy
  • Veterinary and Agrochemical Research Centre
  • Vetoquinol Biowet Sp zoo

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

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

Kevin Yount, Regulatory Affairs Manager, Bayer, May 18

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

Paul McKiernan, Auditor, Elanco Animal Health, May 18

Very good

Petra Marshall, CRA, Boehringer Ingelheim Vetmedica GmbH, Feb 17

Excellent course

Isabel Fidalgo Carvalho, Equigerminal, Oct 16

Excellent course

Isabel Fidalgo Carvalho, Equigerminal, Oct 16