2nd Setting Specifications for Biological Products: A Pathway to Harmonization
This 2nd meeting will expand on considerations discussed in a September 2013 workshop and include participants from biotechnology medicinal products, vaccines, and gene & cell therapies. The goals of this workshop will be to explore the implications from lack of worldwide agreement on principles and practices in setting product specifications and discuss a pathway towards harmonization. Topics will include regulatory and scientific bases for specifications as part of an integrated biologicals control strategy, the roles of scientific and manufacturing data in establishing limits, and possible solutions to achieving worldwide harmonization. Data sources and statistical approaches for setting limits which ensure product quality will be discussed. The meeting will bring worldwide experts together to discuss issues related to harmonization of specifications and through discussion panels and pharmaceutical product class roundtables attempt to reach conclusions that will be valuable globally to public health. Expected outcomes of the workshop are a clear picture of the areas of disagreement across industry and among regulators, as well as similarities and differences among classes of biologicals. Delineation of the scientific principles of specifications and a roadmap towards regulatory harmonization will be explored. Areas of consensus and potential followup will be summarized at the end of the workshop and published in Biologicals.