The RAPS Florida Chapter invites you to participate in a 60-minute webcast covering the importance of quality metrics in regulatory, with particular focus on the differences between CDER and CDRH initiatives.
In 2011, CDRH launched “The Case for Quality” initiative in an effort to advance the focus of industry and FDA beyond compliance towards higher assurance of quality. In 2012, the FDA Safety and Innovation Act (FDASIA) was passed by Congress. Since that time, industry has seen CDRH and CDER move in different directions and at a different pace towards end goals that seem similar, but yet unclear. Our featured presenter co-led with FDA the CDRH Metrics Initiative and co-led with PricewaterhouseCoopers the pharmaceutical metrics initiative, and will address the following points: