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.
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.
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The Regulatory Requirements and Study Design
Protocol Design and Application
Setting up Clinical Trials – A Practical Case Study
Pharmacovigilance Requirements and Considerations
Data Handling and ‘Appropriate’ Statistics
Producing the Final Report
Assuring Quality in Laboratory and Field Studies
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.