Electronic Submissions to FDA for Small Biopharma – What, How, and Who?
With pending FDA mandates for submissions in electronic common technical document (eCTD) form, small biopharma companies have been among the last to adapt to these new approaches and technologies. This webinar will describe the needed IT tools for eCTD submissions, the needed human resources (reg affairs, medical writing, and reg publisher), and differing management approaches to this transition (insource, outsource, or both). This webinar will focus on challenges faced by small biopharma for eSubs and consequently, what the most nimble and cost-effective approaches are to implementation.
About E. Mitchell Seymour:
Mitch Seymour is Principal and Founder of R&D Advisors, LLC. As a consultant, he provides regulatory affairs outsourcing services for industry and academia. Regulatory support services include regulatory writing and regulatory submissions, FDA meeting preparation and engagement, regulatory strategy, regulatory intelligence, and regulatory due diligence. As a life scientist, he has over 20 years experience in basic science and clinical research in industrial and academic settings, spanning diverse therapeutic areas. He is an active lecturer with the Regulatory Affairs Professional Society and the Drug Information Association, as well as various universities. Mitch is also Research Faculty at the University of Michigan Medical School. He has a BS from the University of Notre Dame and a PhD from Michigan State University.
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