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 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 meeting 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 int he company attendees own laboratories.
WHO SHOULD ATTEND:
Personnel involved int he Animal Health industry who are responsible for monitoring Clinical Veterinary Studies, setting up protocols and studies, both in the Laboratory and Field environment to comply with Good Clinical Practice Guidelines. It will be immediately relevant to Quality Assurance professionals who are required to audit these types of studies. Clinical Project Managers and Regulatory Affairs Personnel will also benefit from this course by gaining an overview of the conduct of studies, the regulatory requirements and European perspectives.
10 March 2015: Start 09.30 - Finish 17.00
11 March 2015: Start 09.00 - Finish 16.30
Price: Plus VAT: GBP 1275
Speakers: Julian Braidwood, Managing Director, Triveritas, Marie-Pascale Tiberghien, Animal Health Consultant, Sue Lester, Founding Director, Triveritas