Pharmacovigilance and Risk Management Strategies 2016

Regulatory Authorities such as FDA and EMA provide directions or recommendations on reporting and unblinding clinical trial safety reports to authorities, investigators and IRBs. While unblinding reports is key for identifying any change in the safety profile of an investigational drug, it is important to balance between the need for maintaining trial integrity and identifying and alerting on any potential safety issue. The session will provide practical aspects and perspectives from industry leaders and data monitoring committees on the applied implementation of the different guidances and recommendations.