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.

23-24 Oct 2019

GBP 1,399
EUR 1,959
USD 2,182

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

Book now

23-24 Oct 2019
23-24 Oct 2019 Rembrandt Hotel, London 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 LIMITED
  • Agrovet Market
  • Anatara Lifesciences
  • Animal Health and Veterinary Laboratories Agency
  • Aratana Therapeutics NV
  • BIVRC GmbH & Co. KG
  • BIVRC GmbH &Co. KG
  • Boehringer Ingelheim Animal Health GmbH
  • Boehringer Ingelheim Vetmedica GmbH
  • C Z Veterinaria S.A.
  • CLINGLOBAL LIMITED
  • DADA Consultancy
  • Dyntec, ltd.
  • Equigerminal
  • Federal Agency for Medicine & Health Products
  • Genera
  • INSTITUTE FOR ANIMAL HEALTH
  • Intervet Norbio AS
  • Klifovet A.G.
  • Novartis Animal Health UK Ltd
  • Novartis Animal Health US Inc
  • Pfizer Limited
  • Pharmacosmos
  • PHARMAQ
  • PHARMAQ Zoetis
  • Prof Gianfranco Piva
  • Regivet BV
  • SEGES
  • Veso Vikan Akvavet
  • Veterinary and Agrochemical Research Centre

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