Understanding of the regulations and approval process for veterinary drugs in different continents
Analysing data requirements to obtain marketing authorisations.
Overview of procedures to obtain marketing authorisations for veterinary medicinal products.
Discussing the costs related to the registration procedure.
Finding loopholes: Addressing the possibility of an shortening the length to approval in human to animal drugs based on previous approval for human use.
Foreseeable changes of regulations in Europe and abroad.
DATE »
22.10.2013
AUTHORS »
Lohr, Beate (head of regulatory affairs, KLIFOVET AG)
PUBLISHED »
CPHI 2013 Frankfurt: Animal Health Session