Presented by
Management Forum
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.
★★★★★ "I found the details provided in the webinar and the additional resources/notes were very comprehensi... more"
29-30 Nov 2022
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:
This seminar is sponsored by
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 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.
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.
NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:
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
Until 25 Oct
* 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.
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.
Apr 27 2021
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
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2 days
Typical duration
Pricing from:
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: