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.
This practical four-day course provides a comprehensive understanding of veterinary medicine development in the EU and USA.
Presentations will cover the regulatory framework, pharmaceutical, toxicological and pharmacological data, safety risk assessments, pre-clinical and clinical data, detailed and critical summaries and regulatory submissions.