F. Regulatory and Clinical Development
Regulatory Strategy for Generic Medicines
Explores how to develop a practical regulatory strategy for generic products.
Duration3 hours
Best ForRegulatory managers, product-development teams and business leaders
FormatLive workshop or customized advisory program
Explores how to develop a practical regulatory strategy for generic products. It considers reference-product selection, formulation and strength strategy, bioequivalence, biowaivers, quality evidence, timelines, risk, authority expectations and post-approval lifecycle.