Presented by
Management Forum
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
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:
This seminar will be beneficial to all those working in the animal health industry including:
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.
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.
NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:
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
Until 29 Sep
* 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.
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
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
Regulatory Affairs Officer, Beaphar B.V.
Nov 2 2021
I really thought Julian was excellent, very engaging, and really informed
Siobhan Crowe
Pharmacist, Univet Ltd
May 5 2021
Very good!
Ruud Huibers
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
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
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
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
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
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
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
DVM, Regivet BV
United Kingdom
Netherlands
Germany
Denmark
Belgium
Finland
France
Austria
Ireland
Israel
Italy
Poland
Portugal
Spain
2 days
Typical duration
Pricing from:
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: