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.
2-3 Nov 2021 + 2 more dates
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:
Julian Braidwood qualified as a Veterinary Surgeon and worked in mixed practices before spending fifteen years in R&D and Regulatory departments of five leading Animal Health companies. Julian has managed clinical trials and regulatory groups, experimental facilities, laboratories, and worked internationally in many countries. Having become an R&D Director within the industry, he co-founded Triveritas in 2,000 which grew rapidly internationally and became part of knoell in 2021. knoell is one of the leading service providers for worldwide registration and regulatory compliance in crop protection, crop nutrition, chemicals, cosmetics, animal health products, and medical devices. The knoell Group employs almost 600 people worldwide in more than 14 countries.
knoell is the only knowledge-based animal health consultancy and clinical studies specialist with its own technical staff based on three continents: North America, Europe, and Asia. The animal health team offers a full portfolio of services, including start-to-finish product development and ad hoc services – in all domesticated species for pharmaceuticals and biologicals, feed additives, novel, generic and borderline products.
2-3 Nov 2021
09:00-17:00 UK (London) (UTC+00)
10:00-18:00 Paris (UTC+01)
05:00-13:00 New York (UTC-04)
Course code 11042
Limited places remaining
16-17 May 2022
09:00-17:00 UK (London) (UTC+01)
10:00-18:00 Paris (UTC+02)
04:00-12:00 New York (UTC-04)
Course code 11618
Until 11 Apr
3-4 Nov 2022
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
May 5 2021
Advisor Regulatory Affairs Pharma EU, Elanco Deutschland GmbH
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
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.
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.
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.
DVM, Regivet BV