Post Marketing Studies for Veterinary Medicinal Products in the EU
While the wording of the Summary of Product Characteristics (SPC) is a Primary pre-requisite, the success of a product is also due to well planned post marekting activites. These will include a range of marketing activities, but also possibly regulatory activies. Surveillance of the safety profile is important including Pharmacovigilance and possibly post marketing surveillance studies.The author explained the complexity of such studies, regulatory constraints after implementation of EU directive 2010/63 and legal requriements including the Guideline on post Marketing surveillance studies (EMEA/CVMP/044/99-Final).
DATE »
31.01.2014
AUTHORS »
Hellmann, Klaus (CEO of KLIFOVET AG, Diplomate of the European College of Veterinary Pharmacology and Toxicology, Auditor (EOQ))
PUBLISHED »
1st Munich Seminar on Strategies and the Development of Veterinary Medicinal Products
Munich, Germany
30.-31. January 2014