Course overview
Obtaining a marketing authorisation for a veterinary medicine can be a costly and time-consuming process and this practical two-day course will equip participants with the key information to achieve a successful application.
The programme will take delegates through all of the constituent parts of the application for marketing authorisation for a veterinary medicinal product in the European Union, including the maximum residue limits dossier.
Presentations will cover the regulatory framework; pharmaceutical, toxicological and pharmacological data; safety risk assessments; pre-clinical and clinical data; critical expert reports and regulatory submissions.
An important part of the programme will be devoted to working on case studies in the workshop sessions and there will be ample opportunity for discussion throughout the two days with the expert trainer and fellow professionals.
CPD Hours: 12
Course Content
- Day 1
- EU regulatory framework
- Part 2: Pharmaceutical data requirements
- Maximum Residue Limits (MRLs) and MA Part 3B residues data
- Pharmacokinetics and bioequivalence
- Day 2
- Part 3A of the marketing authorisation (MA) application
- Part 4A: Pre-clinical data
- Part 4B: Clinical data
- EU regulatory strategies and procedures
- Workshop session 1
- Writing the regulatory submission
Speakers
Dave Parry
David Parry is a chemist with over 14 years of experience in in veterinary medicinal product development and registration. In his current position as CMC team leader at knoell, David works with manufacturers in developing formulations and the commercial manufacturing process. Taking advantage of his previous roles in pharmaceutical research and development and process development, David brings a broad range of chemistry, manufacturing and regulatory knowledge to projects. With extensive experience interacting with regulatory authorities in most major global animal health markets and working with contract manufacturing organisations, David is involved with all aspects of regulatory support from early stage development through to post approval product maintenance.
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.
