Regulatory Convergence for Biologics through Capacity Building and Training
1Biopharmaceutical Analysis Training Laboratory, APEC RHSC Center of Regulatory Excellence in Biotherapeutics, Department of Chemistry and Chemical Biology, Northeastern University, Burlington, MA, USA.
Trends in Biotechnology
|June 25, 2018
Abstract:
Several regulatory convergence efforts for biologics are underway globally, with the goal of ensuring global standards are applied consistently across regulatory agencies. Training and capacity building will ensure convergence through fostering international collaborations between agencies and ensure harmonized standards are applied, which will bring products to market faster and cheaper.
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