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Management Forum

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.

★★★★★ "[Particularly liked]: The speaker and his ability to share the information. The complex structure ... more"

13-14 Dec 2022 + 3 more dates

Need help?  Enrol or reserve

  • Format: Live online, Classroom
  • CPD: 12 hours for your records
  • Certificate of completion

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.

Enrol or reserve

The Veterinary Pharmaceutical Submissions in the EU course will cover:

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

Maximum Residue Limits (MRLs) - Safety and residue data requirements

  • MRL dossier: safety file (pharmacology and toxicological studies)
  • MRL dossier: residue file (metabolism and residue studies)

Pharmacokinetics and bioequivalence

Workshop session

Planning a dossier to contain:

  • Pharmaceutical development studies
  • Toxicological, pharmacokinetic, metabolism and residue studies
  • Pre-clinical and clinical studies

Part III of the marketing authorisation application

  • Pharmacology and toxicology studies
  • User safety risk assessment
  • Setting the scenario
  • Risk assessment and management
  • Environmental risk assessment
  • Phase I and II assessments
  • Residue depletion studies
  • Setting the withdrawal period

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

Enrol or reserve

13-14 Dec 2022
6-9 Mar 2023
13-14 Jul 2023
12-13 Dec 2023

Andrew Hewitt

Dr Andrew Hewitt is a veterinarian with over 14 years of experience in Veterinary Medicinal Product development in a clinical and regulatory capacity. In his current position as Senior Advisor for Veterinary Product Development at knoell, Andrew manages all aspects of regulatory input in product development and registration, from early proof of concept right through to post authorisation work. Taking advantage of previous his previous role as a clinical practitioner in the UK, and investigator and monitor on clinical trials, Andrew brings a broad range of clinical and regulatory knowledge to projects. With extensive experience interacting with regulatory authorities in most major global animal health markets, Andrew has a particular interest in strategic regulatory planning during product development.

More details

13-14 Dec 2022
6-9 Mar 2023
13-14 Jul 2023
12-13 Dec 2023

Dave Parry

David Parry is a chemist with over 14 years of experience in in veterinary medicinal product development and registration. In his current position as CMC team leader at knoell, David works with manufacturers in developing formulations and the commercial manufacturing process. Taking advantage of his previous roles in pharmaceutical research and development and process development, David brings a broad range of chemistry, manufacturing and regulatory knowledge to projects. With extensive experience interacting with regulatory authorities in most major global animal health markets and working with contract manufacturing organisations, David is involved with all aspects of regulatory support from early stage development through to post approval product maintenance.

More details

Book Veterinary Pharmaceutical Submissions in the EU Live online/Classroom training

NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:

  • 30% off the 2nd delegate*
  • 40% off the 3rd delegate*
  • 50% off the 4th delegate*

Please contact us for pricing if you are interested in booking 5 or more delegates

13-14 Dec 2022

Live online

09:00-16:30 UK (London) (UTC+00)
10:00-17:30 Paris (UTC+01)
04:00-11:30 New York (UTC-05)
Course code 11788

  • GBP 999 1,199
  • EUR 1,439 1,719
  • USD 1,630 1,942

Until 08 Nov

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Not ready to book yet?

for 7 days, no obligation

6-9 Mar 2023

Live online

13:30-16:45 UK (London) (UTC+00)
14:30-17:45 Paris (UTC+01)
08:30-11:45 New York (UTC-05)
Course code 12194

  • GBP 1,099 1,299
  • EUR 1,589 1,869
  • USD 1,817 2,129

Until 30 Jan

View basket 

 
Not ready to book yet?

for 7 days, no obligation

13-14 Jul 2023

Classroom
Rembrandt Hotel
London

09:00-16:30 UK (London)
Course code 12734

  • GBP 1,299 1,499
  • EUR 1,869 2,149
  • USD 2,137 2,449

Until 08 Jun

  • 2 days classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy

View basket 

 
Not ready to book yet?

for 7 days, no obligation

12-13 Dec 2023

Live online

09:00-16:30 UK (London) (UTC+00)
10:00-17:30 Paris (UTC+01)
04:00-11:30 New York (UTC-05)
Course code 12475

  • GBP 1,099 1,299
  • EUR 1,589 1,869
  • USD 1,817 2,129

Until 07 Nov

View basket 

 
Not ready to book yet?

for 7 days, no obligation

* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price.

Reviews of IPI's Veterinary Pharmaceutical Submissions in the EU training course


[Particularly liked]: The speaker and his ability to share the information. The complex structure of the course. The workshop prepared for us

Dec 6 2021

Daniel Pepa
Jr. Manager GRA Pharma Vetcare, B. Braun Melsungen AG

Dec 6 2021

I enjoyed the event and even through a virtual platform it was very personable. Overall very happy with the large volume of information provided. My aspirations from the meeting were met as I wanted an overall understanding of the regulations.

Brendan Moran
Technical Director, Hygeia

Dec 6 2021

the content was very useful to continue investigating further, the workshop was quite nice also

Karine Tanan
Principal Scientist, Scientific and Regulatory Affairs, Cargill R and D Centre Europe

Mar 3 2021

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 3 2021

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

Nov 18 2020

Very friendly speaker.

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

May 22 2019

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

Nov 26 2019

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.

May 22 2019

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

Nov 26 2019

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.

Apr 25 2018

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

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

Apr 25 2018

I'm very satisfied with the course overall!

Renée Alberda
Supervisor Regulatory Affairs, Kepro B.V.

Apr 25 2018

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

Nov 28 2017

Excellent speaker

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

Nov 28 2017

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

Marie Lovoll
Research Director, VESO

Nov 28 2017

Brilliant speaker

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

Dec 1 2016

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 1 2016

Very good

Renate Makovska
Food & Veterinary Service

United Kingdom

  • Animalcare Ltd
  • Benchmark Animal Health
  • Benchmark Vaccines Ltd
  • British American Tobacco (Investments) Limited
  • Cyton Biosciences Ltd
  • Cyton Biosciences Ltd.
  • Danisco (UK) Limited
  • Diamond BioPharm Ltd
  • DP Consulting
  • ECO Animal Health Limited
  • Eco Animal Health Ltd
  • Eli Lilly & Company Limited/Elanco Animal Health
  • Eli Lilly & Company Ltd
  • Iriska Ltd.
  • MASTERFOODS
  • NOAH ltd
  • Norbrook Laboratories Ltd
  • Novartis Animal Health UK Ltd
  • Pfizer Limited
  • PROBIOTICS INT LTD
  • Veterinary Medicines Directorate
  • VETOQUINOL UK LTD
  • Vita (Europe) Ltd
  • Zoetis

Germany

  • aniMedica GmbH
  • B. Braun Melsungen AG
  • Bayer Animal Health GmbH
  • Bayer Pharma AG
  • Bela-Pharm GmbH & Co. KG
  • Boehringer Ingelheim Animal Health GmbH
  • Boehringer Ingelheim Ltd
  • Boehringer Ingelheim Vetmedica GmbH
  • Dechra Veterinary Products Deutschland GmbH
  • Klifovet A.G.
  • MSD Animal Health Innovation GmbH

France

  • Boehringer Ingelheim
  • Boehringer Ingelheim France
  • CEVA SANTE ANIMAL
  • CEVA Sante Animale
  • Galderma R&D
  • Merial Business
  • Merial SAS
  • Sogeval Laboratories
  • Vetoquinol SA
  • Virbac Corporation

Netherlands

  • Avimedical BV
  • Beaphar B.V.
  • Belgica De Weerd BV
  • Dada Consultancy BV
  • Dopharma Research BV
  • Fort Dodge Animal Health
  • Interchemie werken De Adelaar BV
  • Kepro B.V.
  • ORFFA INTERNATIONAL HOLDING BV
  • Zoetis B.V.

Belgium

  • ARCHE Consulting
  • Cargill R and D Centre Europe
  • Huvepharma
  • Inovet
  • Janssen Pharmaceutica NV
  • Medicem NV
  • VMD
  • Zoetis Belgium S.A.

Norway

  • Dynea AS
  • Nordly Holding AS
  • Pharmaq AS
  • Pharmaq AS, part of Zoetis
  • VESO

Italy

  • Bayer SpA
  • Ceva Salute Animale SPA
  • Fatro SpA
  • MSD Animal Health SRL

Switzerland

  • DR. E. GRAEUB AG
  • Novartis Animal Health Inc
  • Swiss Medic
  • Swissmedic

Denmark

  • DANISH INST FOOD AND VET RESEARCH
  • Jacobsen Pharma & MedTech Advice A/S
  • Leo Animal Health As

Finland

  • Orion Corporation
  • Orion Corporation Orion Pharma
  • Vetcare Oy

Ireland

  • Chanelle Pharmaceutical Manufacturing Ltd.
  • Cross Vetpharm Group Ltd
  • Hygeia

Hungary

  • SELBRUHA Kft.
  • Tiflovet Ltd

Portugal

  • Hifarmax, Produtos e Serviços Veterinários, Lda.
  • ZOOPAN S.A.

Spain

  • Indukern SA
  • KUBUS SA

Austria

  • Vana GmbH

Canada

  • Novartis Animal Health Canada

Isle of Man

  • SEQ Limited

Japan

  • Nippon Zenyaku Kogyo Co., Ltd.

Latvia

  • Food & Veterinary Service

Serbia

  • Medicines and Medical Devices Agency of Serbia

Slovenia

  • Billev Pharma East

Turkey

  • Merial

United States of America

  • Merial

Enrol or reserve

Run Veterinary Pharmaceutical Submissions in the EU Live online/Classroom for your team

2 days

Typical duration

Pricing from:

  • GBP 800
  • Per attendee
  • Course tailored to your requirements
  • At your choice of location, or online

 

We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.

Contact our in-house training expert Aleksandra Beer to discuss your requirements:

Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra BEER
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy