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The New EU (European Union) Animal Health Legislation for Veterinary Medicinal Products Training Course

The programme will offer a comprehensive introduction to the new EU Regulation (2019/6) and will address the changes and implications to the industry including marketing authorisations, submissions and dossiers.

★★★★★ "Julian was speaking in clear language and in a nice tempo (not to quick, not to slow). He acted imme... more"

3-4 Nov 2022

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

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Course overview

The new EU Regulation (2019/6) on Veterinary Medicinal Products will be applicable for all EU countries from 28 January 2022 and will have massive implications for all animal health companies operating in, or wanting to operate in the EU. This seminar will provide essential insight into these revolutionary changes and enable participants to plan their regulatory strategies going forward.

The programme will offer a comprehensive introduction to the legislative changes and will address the new issues, marketing authorisation (MA) submissions and dossiers. Data protection and routes to market will be discussed, as will post-marketing measures and variations. The implications for supply and use, off-label use and inspection controls will also be covered.

This is a must-attend seminar for all animal health professionals.

Benefits of attending:

Be prepared for the revolutionary changes to the EU legislation
Gain essential guidance on the implications of the changes
Understand how this will affect you and your company
Hear the implications on variations
Be aware of the opportunities the changes will create
Comply with data protection and routes to market
Understand the post-market measures
Plan for the impact on supply and use

Who should attend?

This seminar will be beneficial to all those working in the animal health industry including:

Regulatory affairs managers
R&D associates
Manufacturing professionals
Sales and marketing managers
Directors and CEOs
Personnel who are new to the animal health industry and all those needing an overview of the new legislation

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Mel Munro

Dr Mel Munro has worked as a consultant in veterinary medicinal product development and registration for over 20 years. She provides regulatory advice on all areas of biologicals product development taking client projects from proof of concept through to Marketing Authorisation (MA). On a day-to-day basis, she advises on regulatory strategy, performs technical due diligence and gap analyses and prepares strategic development plans and expert reports. She is also experienced in negotiation with the regulators and preparing regulatory documentation. Over her career she has been involved in numerous biologicals projects ranging from more ‘conventional’ vaccines to novel biologicals such as products of rDNA technology, GMO’s, monoclonal antibodies, DNA vaccines and gene therapy.

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Karolina Bate

Karolina has worked in regulatory affairs for over 15 years. Karolina started her career working for Cyton Biosciences, becoming a Managing Director 8 years ago. Since the acquisition of kAH Ltd (formally Triveritas) in 2020, she manages the multi-disciplinary product development support which both companies provide to the animal health industry. Together with support from two other knoell Animal Health consultancies, one based in Germany the other in the USA, and knoell experts in Shanghai; knoell provides global regulatory services to its clients.

Prior to working for Cyton, Karolina carried out her Pharmacology degree and Immunology PhD at the University of Cardiff, Wales. Karolina spent a few years working in University research laboratories and teaching before moving into the field of regulatory affairs.

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Book The New EU Animal Health Legislation for Veterinary Medicinal Products Live online 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*

3-4 Nov 2022

Live online

09:00-17:30 UK (London) (UTC+00)
10:00-18:30 Paris (UTC+01)
05:00-13:30 New York (UTC-04)
Course code 11774

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

Until 29 Sep

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

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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.

Reviews of IPI's The New EU Animal Health Legislation for Veterinary Medicinal Products training course

Julian was speaking in clear language and in a nice tempo (not to quick, not to slow). He acted immediately if a participant wanted to ask a question...Very good, very comprehensive.

Nov 2 2021

Tonny van Dijk Netherlands
Sr. Regulatory Affairs Specialist, Prionics Lelystad B.V.

Nov 2 2021

It was very interesting, thorough and informative. I enjoyed following the course and listening to the presenter.

Rachael Benjamin Netherlands
Regulatory Affairs Officer, Beaphar B.V.

Nov 2 2021

I really thought Julian was excellent, very engaging, and really informed

Siobhan Crowe Ireland
Pharmacist, Univet Ltd

May 5 2021

Very good!

Ruud Huibers Germany
Advisor Regulatory Affairs Pharma EU, Elanco Deutschland GmbH

Nov 2 2021

was really good for me as I am just starting my activities on VMP and I need to understand more new regulation

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

Nov 2 2021

I wanted to hear about the new animal health legislation - which Julian Braidwood succeeded in doing.

Marianne Valentin Hansen Denmark
Drug Safety Specialist, Pharmacosmos

Nov 2 2021

I wanted to get more familiar with the new legislation, to understand a bit more about its background. This course helped me a lot in understanding more of the thoughts behind the various articles.

Charlotte Jacobs Netherlands
Regulatory Affairs Officer, Beaphar B.V.

Nov 11 2020

Content = good however some of the points were of little relevance to me. Presentation = excellent. Very clear slides and the speed of delivery was perfect. Speaker = excellent. Very knowledgeable and happy to discuss topics in depth if required

Rodney Cartmill United Kingdom
Head of Regulatory Affairs - New Products, Norbrook Laboratories Ltd

Dec 9 2019

The main themes of the new Regulation were presented in a precise but detailed manner and this, coupled with the extensive knowledge and sympathetic manner of the speaker, make the course something special.

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

Mar 6 2019

Julian was a fantastic presenter, with excellent examples of real-life scenarios making a potentially dry course thoroughly enjoyable.

Jennifer Hynes United Kingdom
Quality Manager, Benchmark Vaccines Limited

Dec 9 2019

An interesting, informative and interactive two-day course which provided a clear overview and explanation of the most important changes that we can expect as a result of the 2019/6 Legislation. It is not easy to keep the audience interested while explaining a new law but Julian managed to do this excellently.

Kitty Ruigrok Netherlands
DVM, Regivet BV

United Kingdom