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Developing an FDA Regulatory Strategy, an R&Q Webinar
June 30, 2020 @ 1:00 pm - 2:00 pm
Join BioOhio member R&Q for their upcoming webinar, Developing an FDA Regulatory Strategy
This webinar is designed to help you create a comprehensive regulatory strategy that enables you to successfully enter the US market.
This webinar is not is a rehash of the regulations (we’ll provide references, however).
We’ll begin by looking at everything that needs to be included in a thorough regulatory strategy. While viewing the big picture can be daunting at first, it’s a critical step to understanding the strategic process and formulating an efficient, cost-effective plan… that works.
PMA Overview (e.g. requirements, cost, timing)
How to determine if a PMA is necessary vs De Novo vs HDE
Evaluating alternative sources for clinical evidence
Discussion of PMA programs designed to help expedite patient access
Update on CDRH structure and how it affects the PMA review process
Considering the challenges related to EU MDR, this webinar series may be especially helpful to European companies considering the US as a new market.