Evolution of Essential Performance Requirements

For the past several years, pharmaceutical and device constituent manufacturers have encountered FDA requests for Essential Performance Requirements (EPRs) in verification testing, clinical validation, manufacturing control strategies, and bridging strategies. Despite their prevalence and perceived importance, FDA has not issued a formal definition, and ISO 11608-1 released a competing concept called Primary Function. This panel will discuss the inception of EPRs, benefits, and their relationship with Primary Function.

Moderator

• Rumi Young, Director, Regulatory Policy, BD

Speakers

• Matthew Ondeck, Senior Manager Regulatory Affairs, Regeneron Pharmaceuticals
• Subhi Saadeh, Sr. Manager, Quality, Gilead Sciences
• Ashley Boam, Director, Office of Policy, Center for Drug Evaluation and Research (CDER), FDA
• Sarah Mollo, Combination Products Analyst, Center for Devices and Radiological Health (CDRH), FDA
• Alan Stevens, Assistant Director, Injections Team, Center for Devices and Radiological Health (CDRH), FDA