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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
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
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
Protocol Design and Application
- Protocol production and approval
- Protocol content and special points for inclusion
- A case study
Data considerations
- Trial master files
- Paper vs electronic data capture
- ALCOA
- Data verification
- Blind case review and evaluable cases
- Submission of data to regulators
Producing the FSR
- FSR format and authorship
- Appendices and data inclusions
- Amending the FSR
- Archiving the 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
Presenters
Julian Braidwood (More...) (26-27 Oct 2021, 28-29 Oct 2021)
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.
Donna Taylor (More...) (26-27 Oct 2021)
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.
Marie-Pascale Tiberghien (More...) (26-27 Oct 2021, 28-29 Oct 2021)
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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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 1,630 Until 14 Sep* |
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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 1,870 Until 16 Sep* |
Enrol now
to attend Face-to-face (venue not yet confirmed) |
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