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Veterinary Pharmaceutical Submissions in the EU (European Union) Training Course

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.

6-7 Dec 2021

& 9-10 Jun 2022 , 13-14 Dec 2022

Book now

Details

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.

Programme

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

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...)

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. Julian 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 co-founded Triveritas in 2,000 which grew rapidly internationally and became part of knoell in 2021. knoell is one of the leading service providers for worldwide registration and regulatory compliance in crop protection, crop nutrition, chemicals, cosmetics, animal health products, and medical devices. The knoell Group employs almost 600 people worldwide in more than 14 countries.

knoell is the only knowledge-based animal health consultancy and clinical studies specialist with its own technical staff based on three continents: North America, Europe, and Asia. The animal health team offers a full portfolio of services, including start-to-finish product development and ad hoc services – in all domesticated species for pharmaceuticals and biologicals, feed additives, novel, generic and borderline products.

Book now

Book now

6-7 Dec 2021
Live webinar
6-7 Dec 2021
Live webinar
GBP 1,199 999
EUR 1,719 1,439
USD 1,942 1,630
Until 1 Nov*
Enrol now
to attend
Live webinar
9-10 Jun 2022
Live webinar
9-10 Jun 2022
Live webinar
GBP 1,199 999
EUR 1,719 1,439
USD 1,942 1,630
Until 5 May 22*
Enrol now
to attend
Live webinar
13-14 Dec 2022
Live webinar
13-14 Dec 2022
Live webinar
GBP 1,199 999
EUR 1,719 1,439
USD 1,942 1,630
Until 8 Nov 22*
Enrol now
to attend
Live webinar

Learn more about our face-to-face and webinar training formats.

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

Continuing professional development

This course qualifies for 12 hours for your CPD records.
More about CPD

Customised in-house training

We can customise this course to meet the requirements of your organisation and deliver it at your location and/or online.

Contact us

You may also be interested in

Previous customers include...

  • ARCHE Consulting
  • Avimedical BV
  • Beaphar B.V.
  • Benchmark Animal Health
  • Benchmark Vaccines Ltd
  • BOEHRINGER INGELHEIM - ANIMAL HEALTH FRANCE
  • Dopharma Research BV
  • DP Consulting
  • DR. E. GRAEUB AG
  • Dynea AS
  • Eli Lilly & Company Ltd
  • Fatro SpA
  • Hifarmax, Produtos e Serviços Veterinários, Lda.
  • Indukern SA
  • Jacobsen Pharma & MedTech Advice A/S
  • Kepro B.V.
  • MASTERFOODS
  • Merial Business
  • MSD Animal Health SRL
  • NOAH ltd
  • Norbrook Laboratories Ltd.
  • Novartis Animal Health Inc
  • Novartis Animal Health UK Ltd
  • Pharmaq AS
  • PROBIOTICS INT LTD
  • Sogeval Laboratories
  • VESO
  • Veterinary Medicines Directorate
  • VETOQUINOL UK LTD
  • Vita (Europe) Ltd

Great speaker, tremendous experience. I am extremely satisfied with the level of information and knowledge acquired throughout the last 2 days. I would definitely recommend this course and this format to all stakeholders approaching the Veterinary Pharmaceutical Submissions in the EU.

Alessio Giannelli, Regulatory Science Liaison, Inovet, Mar 21

I was overall happy with the webinar. Julian was very clear and ready to answer any question throughout the webinar.

Veronica Nannetti, DVM Regulatory Department, Fatro Spa, Mar 21

Very friendly speaker.

Edouard Timsit, chef de projet recherche - ruminant, CEVA SANTE ANIMAL , Nov 20

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

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

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

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

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

Brilliant speaker

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

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

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