Veterinary Pharmaceutical Submissions in the EU: Two Day Course (London, United Kingdom - November 28-29, 2017) - Research and Markets
DUBLIN, April 6, 2017 /PRNewswire/ --
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 Critcal 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/vc4gxz/veterinary
Media Contact:
Laura Wood, Senior Manager
press@researchandmarkets.com
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