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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, critical expert reports and regulatory submissions.

11-12 July 2024
+ 26-27 November 2024 »
from £1099

Need help? Enrol or reserve

Format: Live online, 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; critical expert reports 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 preparing critical expert report
Consider the pre-clinical and clinical requirements
Take away regulatory strategies and procedures
Acquire the skills to write the regulatory submission

This course forms part of our selection of Animal Health training courses, designed to keep you up to date with the latest regulations surrounding veterinary medicines, animal feeds, and industry best practices.

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

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.

More details

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.

More details

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

11-12 July 2024

Live online

09:00-16:30 UK (London) (UTC+01)
10:00-17:30 Paris (UTC+02)
04:00-11:30 New York (UTC-04)
Course code 13802

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

Until 06 Jun

2 days live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

Online registration unavailable: this date is nearing full capacity; please contact us to register.

26-27 November 2024

Classroom
Rembrandt Hotel
London

08:30-16:30 UK (London)
Course code 14095
Optional £240/€312/$360 per night

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

Until 22 Oct

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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* 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; and apply only when booking multiple delegates on the same date.