Two Day Veterinary Pharmaceutical Submissions in the EU Course (London, United Kingdom - November 28-29, 2017) - Research and Markets

DUBLIN--()--Research and Markets has announced the addition of the "Veterinary Pharmaceutical Submissions in the EU" 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.

Why You Should Attend

- 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

Agenda:

Programme Day One

09.30 Introduction and Objectives of the course

09.45 EU Regulatory Framework

10.45 Refreshments

11.00 Part II: Pharmaceutical Data Requirements

12.15 Discussion

12.30 Lunch

13.30 Workshop session - Planning a dossier to contain

14.45 Part III A: Consumer and Environmental Safety Data Requirements

15.15 User Safety Risk Assessment

15.45 Refreshments

16.00 Pharmacokinetics and Bioequivalence

17.00 End of Day One

Programme Day Two

09.00 Environmental Risk Assessment

09.30 Part III B Residues

10.15 Safety and Residues' Detailed and Critical Summaries

10.30 Refreshments

10.45 Part IV Pre-Clinical Data

11.15 Part IV Clinical Data and Clinical' Detailed and Critical Summary

11.45 EU Regulatory Strategies and Procedures

12.30 Lunch

14.00 Workshop Session

15.00 Refreshments

15.15 Workshop Presentations

15.45 Writing the Regulatory Submission

16.45 Discussion

17.00 End of Course

For more information about this conference visit http://www.researchandmarkets.com/research/xsqjwz/veterinary

Contacts

Research and Markets
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
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Related Topics: Animal Healthcare/Veterinary

Contacts

Research and Markets
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
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Related Topics: Animal Healthcare/Veterinary