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Press Release

Two Day Veterinary Pharmaceutical Submissions in the EU Course - London, United Kingdom - December 1st-2nd, 2016 - Research and Markets

Research and Markets
Posted on: 07 Oct 16

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 authorization for a veterinary medicinal product for which a marketing authorization 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.


Programme Day One

09.30 Introduction and Objectives of the course

09.45 EU Regulatory Framework

- Understanding the regulatory objectives

- EU legal framework

- Legal base of regulatory procedures and dossier requirements

10.45 Refreshments

11.00 Part II: Pharmaceutical Data Requirements

- Formulation and analytical data

- Manufacturing process

- Stability Studies

12.15 Discussion

12.30 Lunch

13.30 Workshop session

Planning a dossier to contain:

- Pharmaceutical development studies

- Toxicological, pharmacokinetic, metabolism and residue studies

- Pre-clinical and clinical studies

14.45 Part IIIA: Consumer and Environmental Safety Data Requirements

- The Toxicological Package

- Maximum Residue Limits dossier: Safety File

- Part IIIA of the Marketing Authorization Application

15.15 User Safety Risk Assessment

- Reviewing toxicology studies

- Setting the scenario

- Risk assessment and management

15.45 Refreshments

16.00 Pharmacokinetics and Bioequivalence

17.00 End of Day One

Programme Day Two

09.00 Environmental Risk Assessment

- Phase I and II Assessments

09.30 Part IIIB Residues

- Metabolism and residue studies

- Maximum Residue Limits dossier: Residues File

- Withdrawal period

- Part IIIB of the Marketing Authorisation Application

10.15 Safety and Residues’ Detailed and Critical Summaries

10.30 Refreshments

10.45 Part IV Pre-Clinical Data

- Pharmacodynamics and pharmacokinetics

- Target species tolerance

- Resistance

11.15 Part IV Clinical Data and ‘Clinical’ Detailed and Critical Summary

- Clinical trials

- Clinical Detailed and Critical Summary

11.45 EU Regulatory Strategies and Procedures

- Full and abbreviated applications

- Generic applications

- Centralised Procedure

- Decentralised, MRP and National Procedures

12.30 Lunch

14.00 Workshop Session

15.00 Refreshments

15.15 Workshop Presentations

- Presentation by each team

- Review and discussion

15.45 Writing the Regulatory Submission

- Writing the dossier

- Summary of Product Characteristics and labelling

- Working with writers of Detailed and Critical Summaries

16.45 Discussion

17.00 End of Course

For more information about this conference visit

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Last updated on: 07/10/2016

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