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Veterinary Pharmaceutical Submissions in the EU Training Course: face to face & live webinar

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.

18-19 Nov 2020

& 16-17 Mar 2021 , 6-7 Dec 2021

Book now

Course overview

Obtaining a marketing authorisation for a veterinary medicine can be a costly and time-consuming process and this practical two-day course will equip participants with the key information to achieve a successful application.

The programme will take delegates 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 and there will be ample opportunity for discussion throughout the two days with the expert trainer and fellow professionals.

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 detailed and critical summaries on safety
  • Consider the pre-clinical and clinical requirements
  • Take away regulatory strategies and procedures
  • Acquire the skills 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.

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

Programme - day 1

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 2

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

Detailed and critical summaries on safety and residues

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

Writing the regulatory submission

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

Presenter

Julian Braidwood (More...)

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

  attend Face to face attend Live webinar
18-19 Nov 2020, Rembrandt Hotel, London
18-19 Nov 2020 Rembrandt Hotel, London GBP 1,199.00
EUR 1,679.00
USD 1,870.00
Until 7 Oct*
Enrol now
Limited places

to attend
Face to face
GBP 999.00
EUR 1,439.00
USD 1,630.00
Until 7 Oct*
Enrol now
Limited places

to attend
Live webinar
16-17 Mar 2021, Venue not yet confirmed
16-17 Mar 2021 Venue not yet confirmed GBP 1,199.00
EUR 1,679.00
USD 1,870.00
Until 2 Feb 21*
Enrol now
to attend
Face to face
GBP 999.00
EUR 1,439.00
USD 1,630.00
Until 2 Feb 21*
Enrol now
to attend
Live webinar
6-7 Dec 2021, Venue not yet confirmed
6-7 Dec 2021 Venue not yet confirmed GBP 1,199.00
EUR 1,679.00
USD 1,870.00
Until 25 Oct 21*
Enrol now
to attend
Face to face
GBP 999.00
EUR 1,439.00
USD 1,630.00
Until 25 Oct 21*
Enrol now
to attend
Live webinar

Learn more about our different training formats.

* Note the early booking discount cannot be combined with any other offers or promotional code

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Previous customers include...

  • aniMedica GmbH
  • ARCHE Consulting
  • Bayer SpA
  • Benchmark Animal Health
  • Boehringer Ingelheim Vetmedica GmbH
  • British American Tobacco (Investments) Limited
  • Chanelle Pharmaceutical Manufacturing Ltd.
  • Cross Vetpharm Group Ltd
  • DP Consulting
  • ECO Animal Health Limited
  • Eco Animal Health Ltd
  • Food & Veterinary Service
  • GALDERMA R & D
  • Hifarmax
  • Huvepharma
  • Janssen Pharmaceutica NV
  • KUBUS SA
  • Medicem NV
  • Merial
  • Nippon Zenyaku Kogyo Co., Ltd.
  • NOAH ltd
  • Nordly Holding AS
  • Novartis Animal Health UK Ltd
  • Orion Corporation Orion Pharma
  • Swiss Medic
  • Vana GmbH
  • Virbac
  • Vita (Europe) Ltd
  • VMD
  • Zoetis B.V.

This course teaches you the essentials of EU veterinary regulatory affairs and enables you to understand the different strategies and how to achieve a successful registration through the excellent content, presentation and speaker who knows to inspire you with his enthusiasm and easy-to-follow way of teaching. Thank you Julian!. I particularly liked the workshop, during which i learnt a lot.

Rachael Benjamin, Regulatory Affairs Officer, Beaphar B.V., Nov 19

Very interesting content and program, presented in a clear, pleasant and appealing way. The workshops were well prepared and very helpful and the speaker was always available to help with any questions.

Marlene Delgado, QPPV, ZOOPAN S.A., Nov 19

A comprehensive course to understand the basis for the registration of animal medicines in EU. Great speaker, easy to listen to.

Ludovique Van Gastel, Scientific Writer, Galderma R&D, May 19

The very complex theme was presented in an exciting, motivating and relaxed way. Connections were presented in a comprehensible way

Heike Luckow, Regulatory Affairs, Bela-Pharm GmbH & Co. KG, May 19

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, Apr 18

I'm very satisfied with the course overall!

Renée Alberda, Supervisor Regulatory Affairs, Kepro B.V., Apr 18

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

Pauline Schipper, Associate Regulatory Affairs Manager, Zoetis B.V., Apr 18

Excellent speaker with interesting and entertaining stories from his own experience.

Marie Lovoll, Research Director, VESO, Nov 17

Excellent speaker

Sandra Lickova, Product Development & Regulatory Affairs Manager, Dr. E. Graeub AG, Nov 17

Brilliant speaker

Sandra Lickova, Product Development & Regulatory Affairs Manager, Dr. E. Graeub AG, Nov 17

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, Dec 16

Very good

Renate Makovska, Food & Veterinary Service, Dec 16