Regulatory expectations for proper safety signal management are more stringent than ever, with 50% of all signals reviewed by the EU Pharmacovigilance Risk Assessment Committee (PRAC) in 2013 resulting in changes in labeling. In the EU, transparency, compliance and quality are critical elements of the pharmacovigilance (PV) legislation. In the U.S., the FDA continues to expect strong and swift signal detection and analysis throughout a product’s lifecycle.
Whether your company holds one or multiple product authorizations, a fit-for-purpose, clear and transparent safety signal management system fully integrated in an IT solution – including signaling strategy setting, prioritization rules, and clear decision points – is core to the success of your PV program.
In this webinar, our presenters will provide key considerations for a successful PV signal management system.
Key Learning Objectives:
You will learn:
Who Should Attend:
Key decision makers involved in the following areas for medicinal products:
Job functions also include: