Dublin, July 06, 2026 (GLOBE NEWSWIRE) -- The "Veterinary Pharmaceutical Submissions in the EU (London, United Kingdom - Nov 19th - Nov 20th, 2026)" has been added to ResearchAndMarkets.com's offering.
Unlock the process of securing a marketing authorisation for veterinary medicines with our intensive two-day course designed to streamline your application process.
This program is meticulously structured to guide professionals through each element of the application for marketing authorisation of a veterinary medicinal product within the European Union framework, including the maximum residue limits dossier. Attendees will engage with detailed presentations on the regulatory intricacies, covering pharmaceutical, toxicological, and pharmacological data essential for compliance.
Participants will gain in-depth insights into the importance of safety risk assessments and the preparation of pre-clinical and clinical data. The course also provides critical evaluations of expert reports and facilitates understanding of effective regulatory submissions.
A distinctive feature of this program is the hands-on workshop sessions dedicated to real-life case studies. These interactive elements foster robust understanding through practical application, enabling participants to refine their strategic approach. Ample opportunities for discussion are integrated throughout the course, encouraging knowledge exchange with the expert trainer and fellow industry professionals.
Upon completion, attendees will earn 12 CPD hours, contributing to their professional development. This course is an essential investment for those seeking expertise in managing the complexities of veterinary regulation and enhancing their career in veterinary medicinal product authorisation.
Who Should Attend:
Personnel working in the following departments:
- Regulatory affairs
- Research and development
- Clinical trials
- Marketing
The course will also be valuable to those seeking to review special problems encountered in the registration of veterinary medicines.
Key Topics Covered:
- Day 1
- EU regulatory framework
- Part 2: Pharmaceutical data requirements
- Maximum Residue Limits (MRLs) and MA Part 3B residues data
- Pharmacokinetics and bioequivalence
- Workshop session 1
- Day 2
- Part 3A of the marketing authorisation (MA) application
- Part 4A: Pre-clinical data
- Part 4B: Clinical data
- EU regulatory strategies and procedures
- 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.
For more information about this training visit https://www.researchandmarkets.com/r/tal3jr
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