This course provides a comprehensive understanding of how to develop a veterinary medicine in the EU and USA. The development of a veterinary medicine is complex, time consuming and expensive. It requires teamwork from individuals with different scientific training and a wide range of skills. Everyone involved must be aware of the main stages in the development programme and be able to relate his or her responsibilities to the expertise and needs of the scientists and commercial members of the team. Furthermore, different approaches taken by the regulatory authorities in the European Union and the 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 and regulatory management 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 European Union and the USA. Presentations will cover pharmaceutical and process development, toxicological, pharmacological, residues and environmental studies, safety risk assessments, clinical development, regulatory and marketing input and project management. An important part of the programme will be devoted to working on case studies in the workshop sessions.
Gain a comprehensive understanding of the processes for the EU and USA, including:
This course has been designed for anyone who has limited experience in only one of the disciplines in veterinary medicine development, such as pharmaceutical or analytical development, clinical trials, regulatory affairs or quality assurance. Anyone learning the role of project manager, as well as more experienced personnel seeking to review special problems encountered in product development, will benefit from the comprehensive programme delivered by experienced professionals.
Previous delegates who have benefited from this course include clinical scientists, pharmaceutical scientists, marketing managers and personnel from regulatory affairs, R&D and development.
Introduction and objectives of course
EU regulatory framework for regulation of veterinary medicines
US regulatory framework for regulation of veterinary drugs
EU and USA: differences and similarities
The global development programmes
USA regulatory strategies and procedures
EU regulatory strategies and procedures
Introduction to workshop – session 1
MRLs Part A safety and MAA Part IIIA
USA FDA approach to HFS studies
MRLs Part B residues and MAA Part IIIB
FDA evaluation of consumer safety
Environmental risk assessment Phases I and II
User safety risk assessment in the EU
Workshop session 2
Pharmacokinetics and bioequivalence
EU and US clinical development
EU and US clinical development (continued)
EU and US target animal safety
Minor use and minor species (MUMS)
Workshop session 3
Pharmaceutical development and the CMC package
Managing the USA regulatory submission
Writing and managing the EU regulatory submission
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.