This practical four day course provides a comprehensive understanding of a veterinary medicine development in the EU and USA.
10-13 Jun 2019
This course provides a comprehensive understanding of how to develop a veterinary medicine in the European Union and USA. Different approaches taken by the regulatory authorities in the EU and USA mean that a comprehensive development programme must be designed in order for the product to be commercialised in both the American and European regions.
This course has been designed to demonstrate how pharmaceutical, pharmacological, toxicological and clinical investigations are brought together in the development programme. It will take the participants through all the stages in the development of a veterinary medicinal product for which a marketing authorisation is sought in the EU and the USA.
A significant part of this course will be devoted to working on case studies in the workshop sessions.
Previous delegates include:
Introduction to Course
EU Regulatory Framework
US Regulatory Framework
EU and US Differences and Similarities
US Regulatory Strategies
EU Regulatory Strategies
Introduction to Workshop WS Session 1
MRLs Part A
US Approach to HFS Studies
MRLs Part B
FDA Evaluation of Consumer Safety HFS
User Safety Risk Assessment
Workshop Session 2
Pharmacokinetics and Bioequivalence
EU and US Clinical Development
EU and US Target Animal Safety
Minor Use Minor Species EU and US
Workshop Session 3
Refreshments and Check out
Pharmaceutical Development and the CMC
Managing tihe US Reg Submission
Writing and Managing the EU Reg Submission
End of Workshop
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.
Dr David Petrick has over 30 years’ experience in bringing novel animal health products to the marketplace. During his professional career he has worked in Regulatory Affairs and Product Development for both American Cyanamid Company and Schering-Plough Animal Health.
In 2004 he founded the Delta Consortium Regulatory Consulting Limited, serving as a consultant in Regulatory Affairs for animal health companies. In 2009 he joined Triveritas and was a part of the opening of Triveritas, USA. In 2004 Dr Petrick joined Velcera, a venture capital funded animal health company and was the Executive Vice President of Research Development and Regulatory Affairs. Velcera was sold to a major pharmaceutical company in 2010.
He holds a degree in veterinary medicine from the University of Pennsylvania, and a law degree from Seton Hall University. He is a member of the American Veterinary Medical Association, the American Bar Association, the New Jersey Bar Association and the New Jersey Bar.