Course overview
This intensive four-day course provides a thorough 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 EU and the USA mean that a comprehensive development programme must be designed in order for the product to be commercialised in both regions.
The event 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 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. 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.
CPD Hours: 24
Course Content
- Day 1
- 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
- Workshop - session 1
- Day 2
- Safety dossier of the EU Maximum Residue Limits application
- USA FDA approach to Human Food Safety studies
- Residues dossier requirements in EU
- FDA evaluation of consumer safety
- Environmental risk assessment Phases I and II
- User safety risk assessment
- Workshop - session 2
- Day 3
- Pharmacokinetics and bioequivalence
- EU and US clinical development
- EU and US target animal safety
- Limited Markets and Minor Use and Minor Species (MUMS)
- Workshop - session 3
- Day 4
- Workshop - presentations
- Pharmaceutical development and the CMC package
- Managing the USA regulatory submission
- Writing and managing the EU regulatory submission
Speakers
David Petrick
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.
Andrew Hewitt
Dr Andrew Hewitt is a veterinarian with over 14 years of experience in Veterinary Medicinal Product development in a clinical and regulatory capacity. In his current position as Senior Advisor for Veterinary Product Development at knoell, Andrew manages all aspects of regulatory input in product development and registration, from early proof of concept right through to post authorisation work. Taking advantage of previous his previous role as a clinical practitioner in the UK, and investigator and monitor on clinical trials, Andrew brings a broad range of clinical and regulatory knowledge to projects. With extensive experience interacting with regulatory authorities in most major global animal health markets, Andrew has a particular interest in strategic regulatory planning during product development.
