Two Day Course: Veterinary Pharmaceutical Submissions in the EU (London, United Kingdom - November 20th-21st, 2018) - ResearchAndMarkets.com

DUBLIN--()--The "Veterinary Pharmaceutical Submissions in the EU" conference has been added to ResearchAndMarkets.com's offering.

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

Course Overview

This practical two-day In-house 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 Critical Summary
  • Consider the Pre-Clinical and Clinical Requirements
  • Take Away Regulatory Strategies and Procedures
  • Know How to Write the Regulatory Submission

Who Should Attend:

Personnel working in the following departments: Regulatory Affairs, Research and Development and Clinical Trials and Marketing. It will also be valuable to those seeking to review special problems encountered in the registrations of veterinary medicines. There will be ample opportunity for discussion during the proceedings.

For more information about this conference visit https://www.researchandmarkets.com/research/qflxj7/two_day_course?w=4

Contacts

ResearchAndMarkets.com
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
Related Topics: Animal Healthcare/Veterinary

Contacts

ResearchAndMarkets.com
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
Related Topics: Animal Healthcare/Veterinary