Biography
Biography: Khaudeja Bano
Abstract
Combination products present a unique challenge globally for industry and the regulators regardless if you consider pharmaceuticals or biologics, devices or diagnostics. As the US and Japan have expressed their views in the form of draft guidance and regulations, organizations are working towards a streamlined process that best meets their needs. Combination products present challenges that need to be evaluated to better prepare for the future and to demonstrate an organization’s compliance. Let us consider how to develop integrated cGMP and Regulatory Strategies for combination products. With two or more components; two Quality Systems; two or more databases; one or more Postmarketing Safety Report(s) what Is an Organization to do? How does the organization set up the right culture? Some best practices to consider. Risk based safety assessments may be a solution.