Practical Implementation of GCP in Veterinary Field Studies

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.

3-4 Apr 2019

& 23-24 Oct 2019

GBP 1,399 1,199 *
EUR 1,959 1,679 *
USD 2,182 1,870 *
* When you book before 11 Jan

Book now

Course Overview

The course will address a typical case study where a practical approach will be made to setting up, running and monitoring clinical trials followed by an audit of these studies to satisfy the stringent requirements seen in Europe. Standard documentation utilised for recording data, performing audits and a typical protocol will be supplied for use in the company attendees’ own laboratories.

Benefits of attending:

  • Understand the regulatory requirements and study design
  • Know how to design protocols and apply them
  • Take away practical advice on how to set up clinical trials
  • Clarify the pharmacovigilance requirements
  • Gain a better understanding of data handling and ‘appropriate’ statistics
  • Discover how to produce the final report
  • Assure quality in laboratory field 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 Day One

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

Pharmacovigilance Requirements and Considerations

  • Recent regulatory developments
  • Impact on clinical studies

17.00 Close of Day One

Programme Day Two

Data Handling and ‘Appropriate’ Statistics

  • Review of the current CVMP statistics guidelines
  • Types of data
  • Types of statistics
  • Evaluation of data
  • A case study

Producing the Final Report

  • Data and QC
  • Archiving data
  • A case study

Assuring Quality in Laboratory and Field Studies

  • Standard Operating Procedures (SOPs) writing, use and review
  • The QA function
  • Interaction between GLP, GCP and GMP in veterinary studies
  • Pre-study involvement
  • Protocol review
  • Audit planning
  • In-life audit
  • Sponsor/site trial master file review

Discussion will take place throughout the two days

Presenters

Sue Lester (3-4 Apr 2019)

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 (3-4 Apr 2019)

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 (3-4 Apr 2019)

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. She is currently based in Monheim, Germany, with Bayer Animal Health Global Marketing and is responsible for technical marketing activities for new products intended for use in food-producing animals.

Book now

3-4 Apr 2019
3-4 Apr 2019 Cavendish Hotel, London GBP 1,399.00
EUR 1,959.00
USD 2,182.00
+ VAT @ 20.00%
GBP 1,199.00
EUR 1,679.00
USD 1,870.00
Until 11 Jan
Enrol now
23-24 Oct 2019
23-24 Oct 2019 Venue not yet confirmed GBP 1,399.00
EUR 1,959.00
USD 2,182.00
+ VAT @ 20.00%
Enrol now

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Previous customers include...

  • ADAS UK Ltd
  • Agrovet Market
  • Anatara Lifesciences
  • Animal Health and Veterinary Laboratories Agency
  • Aratana Therapeutics NV
  • Benchmark Animal Health Ltd
  • Boehringer Ingelheim Animal Health GmbH
  • Boehringer Ingelheim Ltd
  • Boehringer Ingelheim Veterinary Research Center GmbH & Co.KG
  • Boehringer-Ingelheim Danmark A/S
  • CEVA
  • Ceva Phylaxia Co Ltd
  • CEVA Sante Animale
  • Delaval NV
  • Dyntec, ltd.
  • Elanco Animal Health
  • Fort Dodge Animal Health Ltd UK
  • Intervet Norbio AS
  • Merial SAS
  • National Drug Authority
  • Orion Corporation
  • Pfizer Limited
  • PHARMAQ Zoetis
  • Probiotics International Ltd
  • State University of Ghent
  • The Royal Veterinary College
  • Tonisity International
  • Triveritas Limited
  • Veso Vikan Akvavet
  • Veterinary Laboratories Agency

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

Paul McKiernan, Auditor, Elanco Animal Health

All very engaging. Appropriate depth/pace. Concise [and] thorough.

Sophie Nixon, Veterinary Research Manager, Probiotics International Ltd

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

Kevin Yount, Regulatory Affairs Manager, Bayer

Very good

Petra Marshall, CRA, Boehringer Ingelheim Vetmedica GmbH

Excellent course

Isabel Fidalgo Carvalho, , Equigerminal

Excellent course

Isabel Fidalgo Carvalho, , Equigerminal