Veterinary Pharmaceutical Submissions in the EU

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.

Benefits of attending:

• Understand the EU regulatory framework
• Learn the pharmaceutical data requirements
• Know how to comply with the safety requirements
• Review the user safety risk assessment
• Consider the environmental risk assessment
• Receive guidance on preparing critical expert report
• Consider the pre-clinical and clinical requirements
• Take away regulatory strategies and procedures
• Acquire the skills to write the regulatory submission