Veterinary Pharmaceutical Submissions in the EU

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

22-23 May 2019

& 26-27 Nov 2019

GBP 1,399
EUR 1,959
USD 2,182

Book now

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

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.

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

You might also be interested in

Veterinary Pharmaceutical Submissions in the EU
A Practical Approach to Veterinary Vaccine Development and Registration in the EU
Developing Medicines for Companion Animals

Further details for the above meetings will be available in due course, in the meantime if you have any queries please click here to email us

Presenter

Julian Braidwood (22-23 May 2019)

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.

Book now

22-23 May 2019
22-23 May 2019 Cavendish Hotel, London GBP 1,399.00
EUR 1,959.00
USD 2,182.00
+ VAT @ 20.00%
Enrol now
26-27 Nov 2019
26-27 Nov 2019 Cavendish Hotel, London GBP 1,399.00
EUR 1,959.00
USD 2,182.00
+ VAT @ 20.00%
Enrol now

You may also be interested in

Previous customers include...

  • Bayer Pharma AG
  • Bayer SpA
  • Boehringer Ingelheim Animal Health GmbH
  • Boehringer Ingelheim Vetmedica GmbH
  • CEVA Sante Animale
  • Cross Vetpharm Group Ltd
  • DANISH INST FOOD AND VET RESEARCH
  • Diamond BioPharm Ltd
  • Dopharma Research BV
  • DR. E. GRAEUB AG
  • Eli Lilly & Company Ltd
  • Fort Dodge Animal Health
  • Indukern SA
  • Jacobsen Pharma & MedTech Advice A/S
  • Janssen Pharmaceutica NV
  • Kepro B.V.
  • MASTERFOODS
  • Medicem NV
  • Merial
  • Merial Business
  • Novartis Animal Health Inc
  • Pharmaq AS
  • PROBIOTICS INT LTD
  • Swissmedic
  • Tiflovet Ltd
  • VESO
  • VETOQUINOL UK LTD
  • Zoetis
  • Zoetis B.V.
  • Zoetis Belgium S.A.

Very nice presentation and all the 'real life' stories were of added value. Good interesting course with a very nice group.

Iris Visser, Regulatory Affairs Officer, Belgica De Weerd BV

I'm very satisfied with the course overall!

Renée Alberda, Supervisor Regulatory Affairs, Kepro B.V.

Great speaker, easy to listen to. Good sense of humour.

Pauline Schipper, Associate Regulatory Affairs Manager, Zoetis B.V.

Excellent, very clean, interesting and entertaining stories from speakers own experience

Marie Lovoll, Research Director, VESO

Excellent speaker

Sandra Lickova, Product Development & Regulatory Affairs Manager, Dr. E. Graeub AG

Brilliant speaker

Sandra Lickova, Product Development & Regulatory Affairs Manager, Dr. E. Graeub AG

The content, presentations and speaker was very good - and I got a whole lot out of it

Mads Thor Madsen, Medical Advisor, DVM, Jacobsen Pharma & MedTech Advice A/S

Very good

Renate Makovska, , Food & Veterinary Service