This In-house course will provide a comprehensive introduction to the entire development programme for companion animal medicines.
This In-house course has been designed to demonstrate how pharmaceutical, pharmacological, toxicological, pharmacological, safety risk assessments, clinical development, and regulatory submissions. An important part of the course will be devoted to working on case studies in the workshop sessions.
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Introduction and Objectives of the Course
EU Regulatory Framework
Assessing Development Candidates
Introduction to Workshop
Process Scale up and Validation
Workshop: Understanding How to “Block Out Studies”
The Toxicological Package
User Safety: Risk Assessment
Pharmacokinetics and Bioequivalence
Environmental Risk Assessment
Planning Pre-Clinical and Clinical Development
EU Regulatory Strategies and Procedures
Target Species Tolerance
Minor Use and Minor Species (MUMS)
Final Workshop Session
Writing and Managing the Regulatory Submission
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.