A Template for Adverse Event Reporting in Licensing Agreements

Abstract

The licensing of products by pharmaceutical manufacturers has become more frequent in recent times. Multiple companies are now developing, studying, and marketing the same product. The need for coordinated adverse event collection, processing, and reporting in order to remain in regulatory compliance in these situations is now becoming very evident. Schering-Plough Corporation's Drug Safety Surveillance Department has developed a template covering the points which need to be addressed in negotiations between or among companies in order to develop a written procedure for adverse event handling.