DUBLIN--(BUSINESS WIRE)--Research and Markets (http://www.researchandmarkets.com/research/4lk7hz/veterinary) has announced the addition of the "Veterinary Pharmaceutical Submissions in the EU (London, UK - December 7-8, 2015)" conference to their offering.
This practical two-day course will take participants through all of the constituent parts of the application for marketing authorisation for a veterinary medicinal product for which a marketing authorisation is sought 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 course will be devoted to working on case studies in the workshop sessions. The course will provide a comprehensive introduction to the entire regulatory dossier for a veterinary medicinal product in the European Union.
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 the Safety' Detailed and Critcal Summary
- Consider the Pre-Clinical and Clinical Requirements
- Take Away Regulatory Strategies and Procedures
- Know How to Write the Regulatory Submission
For more information visit http://www.researchandmarkets.com/research/4lk7hz/veterinary