University at Buffalo 1 credit Management and Policy
The course will survey key elements and requirements of drug and device regulatory submissions, including an introduction to design control processes and discuss their needs and strategy within overall business planning. The advantages and requirements for 510k vs PMA submissions will be addressed along with device classifications, submission structure and key elements necessary to demonstrate safety and efficacy including verification and validation activities. The applicability of Standard drug pathways including investigational new drug (IND) and transition to new drug application (NDA) and abbreviated new drug application (ANDA) will be discussed along with examination of clinical trial structures and requirements. Both regulatory paths will be discussed within the context of impact and planning on overall business strategy. The course will include examples from experience with the regulatory process with a number of products.
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