The programme will offer a comprehensive introduction to the new legislation Regulation (EU) 2019/6 and will address the changes and implications to the industry including marketing authorisations, submissions and dossiers. NEW EVENT!
6-7 Mar 2019
& 9-10 Dec 2019
The new EU animal health legislation (EU Regulation 2019/6) for veterinary medicinal products 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 on supply and use, off-label use and inspection controls will also be addressed. This is a must-attend seminar for animal health professionals.
Benefits of attending:
This seminar will be beneficial to all those working in the animal health industry including:
Welcome and introduction
Overview of the new regulation
Scope, general provisions and rules
Data protection and routes to market
Limited MAs, referrals, homeopathy, manufacturing
Supply and use
Supply and use (continued)
Inspections and controls
Dr 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. He 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 formed Triveritas in 2000 which has grown rapidly throughout Europe and North America and has offices in UK, France, Germany, Poland and USA. Triveritas provides specialist contract services to Animal Health and related companies. Triveritas develops veterinary vaccines and medicines by providing comprehensive services in veterinary regulatory affairs, regulatory maintenance, international clinical trials, QA, project/study management, and training. A tailored start to finish service takes client projects from proof of concept through to multi-national registrations.