Tutorials are not included in the meeting registration and require a separate registration fee.

This half-day tutorial will cover experience in operationalizing the ICH E2C(R2) PBRER guideline since November 2012, when the guideline reached ICH Step 4. The guideline is now at ICH Step 5, having been implemented in the EU. Indeed, the PBRER format, content, and analytical focus are accepted in many countries, including the US and Japan. Further, the PBRER may eventually replace certain other requirements for postmarketing safety data and analysis, which could make the pharmacovigilance enterprise more efficient in transferring value to patients. While this presents an opportunity to advance patient safety, practical challenges must be overcome by regulators, MAHs, and service providers. In addition, assessment reports are now becoming available for use in a continuous improvement mode. This new report represents a significant change from the previous PSUR format and a quantum leap forward to a document that incorporates many new concepts including an integrated evaluation of both benefits and risks of a medicinal product.

Lunch will not be served for a half day tutorial.