- Home
- Industry
- Animal Health
- The New EU Animal Health Legislation for Veterinary Medicinal Products
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.
3-4 Nov 2022
Details
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
Presenters
Mel Munro (More...)
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 Bate (More...)
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.
Book now
Book now
NEW higher discounts for booking multiple places - 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 webinar 09:00-17:30 UK (London) |
|||
|
3-4 Nov 2022 Live webinar 09:00-17:30 UK (London) |
GBP 1,199 999 EUR 1,719 1,439 USD 1,942 1,630 Until 29 Sep* |
Enrol now
to attend Live webinar |
|
Learn more about our face-to-face and webinar training formats.
* Note the early booking discount cannot be combined with any other offers or promotional code. As such, discounts for the 2nd/3rd/4th attendees are based on the full price of the course. Please contact us for pricing if you wish to send more than 4 delegates.