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 Critcal 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.
Agenda:
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 Authorisation 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
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