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.

28-29 Apr 2022

& 30 Jun-1 Jul 2022 , 20-21 Oct 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 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

Presenters

Julian Braidwood (More...)

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.

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, 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.

Book now

Book now

28-29 Apr 2022
Live webinar
28-29 Apr 2022
Live webinar
GBP 1,199 999
EUR 1,719 1,439
USD 1,942 1,630
Until 24 Mar 22*
Enrol now
to attend
Live webinar
30 Jun-1 Jul 2022
Face-to-face, (venue not yet confirmed)
30 Jun-1 Jul 2022
Face-to-face
(venue not yet confirmed)
GBP 1,399 1,199
EUR 1,959 1,679
USD 2,182 1,870
Until 26 May 22*
Enrol now
to attend
Face-to-face
(venue not yet confirmed)
  • 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
20-21 Oct 2022
Live webinar
20-21 Oct 2022
Live webinar
GBP 1,199 999
EUR 1,719 1,439
USD 1,942 1,630
Until 15 Sep 22*
Enrol now
to attend
Live webinar

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

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...

  • Bayer Animal Health GmbH
  • Benchmark Animal Health Ltd
  • C Z Veterinaria S.A.
  • Ceva-Phylaxia Co Ltd
  • Chanelle Pharmaceutical Manufacturing Ltd.
  • CLINGLOBAL LIMITED
  • Delaval NV
  • Dyntec, ltd.
  • EirGen Pharma Ltd
  • EWOS Innovation
  • Federal Agency for Medicine & Health Products
  • Fish Vet Group
  • MED-EL Medical Electronics
  • Merck Sharp Dohme (Europe) Inc.
  • Merial SAS
  • MSD AH Innovation GmbH
  • National Drug Authority
  • Norbrook Laboratories Ltd
  • Novartis Animal Health US Inc
  • Nutriad International BV
  • Pfizer Limited
  • Pharmaq AS
  • Poulpharm
  • Royal Veterinary College
  • SEGES
  • State University of Ghent
  • STIM AS
  • The Pirbright Institute
  • Vetcare Oy
  • Veterinary and Agrochemical Research Centre

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

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