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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.
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
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.
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.
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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27-28 Apr 2021 Live webinar |
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27-28 Apr 2021 Live webinar |
GBP 1,199 999 EUR 1,719 1,439 USD 1,942 1,63 Until 16 Mar* |
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to attend Live webinar |
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26-27 Oct 2021 Live webinar |
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26-27 Oct 2021 Live webinar |
GBP 1,199 999 EUR 1,719 1,439 USD 1,942 1,63 Until 14 Sep* |
Enrol now
to attend Live webinar |
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28-29 Oct 2021 Face-to-face, (venue not yet confirmed) |
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28-29 Oct 2021 Face-to-face (venue not yet confirmed) |
GBP 1,399 1,199 EUR 1,959 1,679 USD 2,182 1,87 Until 16 Sep* |
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to attend Face-to-face (venue not yet confirmed) |
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