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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"

12-13 December 2023
from £1299

Need help? Enrol or reserve

Format: Classroom
CPD: 12 hours for your records
Certificate of completion

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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

This course is part of our Regulatory Affairs Training course collection, which features updates on the latest regulations to registration procedures and strategies.

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:

Day 1
Day 2

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

Dave Parry
knoell Animal Health

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.

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Andrew Hewitt
Knoell Animal Health

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.

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Colin McLean
knoell Animal Health

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Book Veterinary Pharmaceutical Submissions in the EU 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

12-13 December 2023

Classroom
Rembrandt Hotel
London

08:30-16:30 UK (London)
Course code 12734
Optional £195/€280/$320 per night

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

Until 07 Nov

2 days classroom-based training
Optional accommodation - 2 nights including breakfast, checking in the day before the course
Meet presenters and fellow attendees in person
Lunch and refreshments provided
Download documentation and certification of completion
Fair transfer and cancellation policy

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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

Excellent presentation with very useful content and information. Great speakers with brilliant experience who were always available to respond any question.

Mar 6 2023

Karen Vásquez Cruz Ireland
Regulatory Affairs Officer, Hygeia Chemicals Limited

Mar 6 2023

The overall opinion is that the webinar was great.

Johanna Axling Sweden
Product manager, FarmPharma

Dec 6 2021

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

Daniel Pepa Germany
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 Ireland
Technical Director, Hygeia

Dec 6 2021

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

Karine Tanan Belgium
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 Italy
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 Belgium
Regulatory Science Liaison, Inovet

Nov 18 2020

Very friendly speaker.

Edouard Timsit France
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 France
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 Netherlands
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 Germany
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 Portugal
QPPV, ZOOPAN S.A.