Veterinary Pharmaceutical Submissions in the EU

This In-house coursewill cover the regulatory framework, pharmaceutical, toxicological and pharmacological data, safety risk assessments, pre-clinical and clinical data, Detailed and Critical Summaries and regulatory submissions

In-house Training and Consultancy Services

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.

Your next step is to call us now on +44 (0)20 7749 4730 or email us at info@management.forum.co.uk or use our contact form and find out how we can help. There are no commitments, and if we cannot help our advice and recommendations are free of charge.

Sample programme - Day one

EU Regulatory Framework

  • Understanding the regulatory objectives
  • EU legal framework
  • Legal base of regulatory procedures and dossier requirements

Part II: Pharmaceutical Data Requirements

  • Formulation and analytical data
  • Manufacturing process
  • Stability Studies

Workshop session

Planning a dossier to contain:
  • Pharmaceutical development studies
  • Toxicological, pharmacokinetic, metabolism and residue studies
  • Pre-clinical and clinical studies

Part IIIA: Consumer and Environmental Safety Data Requirements

  • The Toxicological Package
  • Maximum Residue Limits dossier: Safety File
  • Part IIIA of the Marketing Authorisation Application

User Safety Risk Assessment

  • Reviewing toxicology studies
  • Setting the scenario
  • Risk assessment and management

Pharmacokinetics and Bioequivalence

Sample programme - Day two

Environmental Risk Assessment

  • Phase I and II Assessments

Part IIIB Residues

  • Metabolism and residue studies
  • Maximum Residue Limits dossier: Residues File
  • Withdrawal period
  • Part IIIB of the Marketing Authorisation Application

Safety and Residues’ Detailed and Critical Summaries

Part IV Pre-Clinical Data

  • Pharmacodynamics and pharmacokinetics
  • Target species tolerance
  • Resistance

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

  • Clinical trials
  • Clinical Detailed and Critical Summary

EU Regulatory Strategies and Procedures

  • Full and abbreviated applications
  • Generic applications
  • Centralised Procedure
  • Decentralised, MRP and National Procedures

Writing the Regulatory Submission

  • Writing the dossier
  • Summary of Product Characteristics and labelling
  • Working with writers of Detailed and Critical Summaries

Recommended trainer

Dr.Julian Braidwood

Julian qualified as a Veterinary Surgeon and worked in mixed practices before spending fifteen years in R&D and Regulatory departments of five leading Animal Health companies. He has managed clinical trials and regulatory groups, experimental facilities, laboratories, and worked internationally in many countries. Having become an R&D Director within the industry, he formed Triveritas in 2000 which has grown rapidly throughout Europe and North America and has offices in UK, France, Germany, Poland and USA. Triveritas provides specialist contract services to Animal Health and related companies. Triveritas develops veterinary vaccines and medicines by providing comprehensive services in veterinary regulatory affairs, regulatory maintenance, international clinical trials, QA, project/study management, and training.