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

26-27 Nov 2019

& 24-25 Mar 2020 , 18-19 Nov 2020

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

Book now

Course Overview

This course will take participants through all of the constituent parts of the application for marketing authorisation for a veterinary medicinal product 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 programme will be devoted to working on case studies in the workshop sessions.

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 critical summaries
  • 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
• Clinical trials
• Marketing

The course will also be valuable to those seeking to review special problems encountered in the registrations of veterinary medicines.

Programme Day One

Introduction and objectives of the course

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

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 summaries

  • Clinical trials
  • Clinical detailed and critical summaries

EU regulatory strategies and procedures

  • Full and abbreviated applications
  • Generic applications
  • Centralised procedure
  • Decentralised, MRP and national procedures

Workshop session

Workshop presentations

  • Presentation by each team
  • Review and discussion

Writing the regulatory submission

  • Writing the dossier
  • Summary of product characteristics and labelling
  • Working with writers of detailed and critical summaries

Discussion session

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

Book 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
24-25 Mar 2020
24-25 Mar 2020 Venue not yet confirmed
+ VAT @ 20.00%
Online registration unavailable: this date is nearing full capacity; please call us on 020 7749 4730 to register.
18-19 Nov 2020
18-19 Nov 2020 Venue not yet confirmed
+ VAT @ 20.00%
Online registration unavailable: this date is nearing full capacity; please call us on 020 7749 4730 to register.

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Previous customers include...

  • Bayer Pharma AG
  • Bayer SpA
  • Bela-Pharm GmbH & Co. KG
  • Benchmark Animal Health
  • Benchmark Vaccines Ltd
  • Boehringer Ingelheim Vetmedica GmbH
  • British American Tobacco (Investments) Limited
  • Ceva Salute Animale SPA
  • Cyton Biosciences Ltd
  • Diamond BioPharm Ltd
  • Dynea AS
  • Fatro SpA
  • Huvepharma
  • Indukern SA
  • Jacobsen Pharma & MedTech Advice A/S
  • Merial
  • NOAH ltd
  • Orion Corporation Orion Pharma
  • Pfizer Limited
  • Pharmaq AS
  • SEQ Limited
  • Tiflovet Ltd
  • VESO
  • Vetcare Oy
  • Virbac
  • Vita (Europe) Ltd
  • VMD

I'm very satisfied with the course overall!

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

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

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

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

Excellent speaker

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

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

Marie Lovoll, Research Director, VESO

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