This month’s luncheon will feature a presentation from EMMA International, a consulting group specializing in life science quality, regulatory and compliance matters.
In year two of the Trump Administration, the FDA Commissioner, Scott Gottlieb, has a lot in mind to accomplish. The focus of this workshop is to highlight FDA’s 2018 agenda for the Medical Device industry and its impact on your organization.
One item on the agenda, which was initially proposed in 2013, is that, by March 2018, FDA seeks to finalize a rule that would update FDA requirements to allow the use of clinical data from outside the US.
We will discuss Dr. Gottlieb’s goals for the industry in 2018, as well as the creation of the so called “Super Office” at the Center for Devices and Radiological Health (CDRH).
This event is available only to clients of the WMed Innovation Center and invited guests.
This Lunch and Learn sponsored by EMMA International.