Practical Implementation of GCP in Veterinary Field Studies

This In-house course will take many aspects of animal health and veterinary research and development through a typical clinical trial and pay attention to compliance with GCP as outlined in the two guidelines on safety and efficacy produced by FEDESA and CVMP.

In-house Training and Consultancy Services

This In-house will take many aspects of animal health and veterinary research and development through a typical clinical trial, and pay attention to compliance with GCP as outlined in the two guidelines on safety and efficacy produced by FEDESA and the CVMP. The programme 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.

Your next step is to call us now on +44 (0)20 7749 4730 or email us at info@management.forum.co.uk or use our contact form and find out how we can help. There are no commitments, and if we cannot help our advice and recommendations are free of charge.

Sample 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

Sample 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

Recommended Trainer

Dr.Julian Braidwood

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.