By July 2, 2015, all marketing authorizations (MAs) in the European Union will need to implement the Pharmacovigilance System Master File (PSMF). It’s a document that can overwhelm even the most seasoned drug safety professional.
In this recorded webinar, Dr. Vineet Kacker, APCER Pharma’s Managing Director, Global Technical Head, and a QPPV responsible for many PSMFs, breaks the process down into manageable steps that have proven to deliver the critical content elements that regulators expect to see.
Mastering the Pharmacovigilance System Master File
Creating and maintaining a PSMF that stands up to regulatory scrutiny
Recorded: Tuesday, April 28, 2015
Length: 1 hour
Agenda
• Understanding the Regulatory Expectations
• Identifying the Spread of Information
• Employing an Interdisciplinary Approach
• Focusing on the Critical Content Elements
• Replacing the DDPS with the PSMF
• Maintaining the Log Book
• Q&A