Lifecycle approach to validation supports accelerated approvals
April 23-26, 2017
The product lifecycle management paradigm provides a structured pathway for both process and analytical validation. This framework relies on statistical approaches integrated with science and engineering.
Fast-moving products with orphan drug status or breakthrough designation must still meet the standard regulatory requirements and process for obtaining marketing approval; this requires an efficient, methodical, and well-organized approach.
This presentation will include examples of the product lifecycle management approach to process and analytical validation applied to orphan and breakthrough designation products moving rapidly through review. Statistical concepts and techniques essential to application of this strategy will be highlighted.
Julia O’Neill, "Lifecycle approach to validation supports accelerated approvals" in "Regulatory Sciences for Biologics and Vaccines: Accelerating Development and Enabling Manufacturing Innovation", Prof. Antonio Moreira (University of Maryland, Baltimore County, USA) Dr. David Robinson (Robinson Vaccines and Biologics LLC, USA) Eds, ECI Symposium Series, (2017). http://dc.engconfintl.org/biologics_vaccines/10