Stream 5

Regulatory & Risk Management

The weeklong Regulatory & Risk Management stream offers a comprehensive view of the steps required of bioprocess organizations to support regulatory filings and maintain control over product quality and safety. Two case study forums present best practices for design space development, process characterization, and new strategies and tools for detection, prevention and handling of viral contamination incidents in biomanufacturing. And a 1.5 training seminar presents detailed information in a tutorial format on the requirements and informal expectations of the major regulatory agencies at preclinical, clinical and commercial stage.

Conferences Include:

August 3-4
Bioprocess Quality and Regulatory Compliance

August 5-6
Training Seminar: Current and Emerging Global Regulatory Expectations for Analytical

August 6-7
Viral Clearance and Safety of Biologics