Veterinary Pharmaceutical Submissions in the EU (London, United Kingdom - April 25-26, 2018)

  • ID: 4435759
  • Conference
  • Location: London, United Kingdom
  • 2 Days
  • Management Forum
  • Conference Dates: April 25-26, 2018
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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.

Why you should attend

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

Please note, events may be cancelled due to commercial or organisational reasons. In this case Research and Markets will refund all registration fees which have already been paid. Research and Markets will not refund any charges arising from the participant having to cancel or re-book transportation or accommodation which he or she has arranged.

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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

16.45 Discussion

17.00 End of Course

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  • Julian Braidwood Dr Julian Braidwood,
    Veterinary Surgeon and R&D Director ,
    Triveritas


    Dr Julian Braidwood 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. A tailored start to finish service takes client projects from proof of concept through to multi-national registrations.

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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.

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ADDRESS

The Cavendish Hotel
81 Jermyn Street
London
SW1Y 6JF
United Kingdom

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