About Veterinary Pharmaceutical Submissions in the EU
This course will take participants through all of the constituent parts of the application for marketing authorization 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; detailed and critical summaries; and regulatory submissions. An important part of the program will be devoted to working on case studies in the workshop sessions.
Benefits of attending:
1) Understand the EU regulatory framework
2) Learn the pharmaceutical data requirements
3) Know how to comply with the safety requirements
4) Review the user safety risk assessment
5) Consider the environmental risk assessment
6) Receive guidance on the ‘safety’ Detailed and Critical Summaries7)
7) Consider the pre-clinical and clinical requirements
8) Take away regulatory strategies and procedures
9) Know how to write the regulatory submission