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2-Day Course: Veterinary Pharmaceutical Submissions in the EU (London, United Kingdom – May 22-23, 2019) – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Veterinary
Pharmaceutical Submissions in the EU”
conference has been added
to ResearchAndMarkets.com’s offering.

This course will take participants through all of the constituent parts
of the application for marketing authorisation 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 programme will be
devoted to working on case studies in the workshop sessions.

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.

The course will provide a comprehensive introduction to the entire
regulatory dossier for a veterinary medicinal product in the European
Union.

Benefits of Attending

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.

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 IIIA: 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 IIIB 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 https://www.researchandmarkets.com/r/ykoox4

Contacts

ResearchAndMarkets.com
Laura Wood, Senior Press 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

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