Thursday, 18 April 2019
5:30–8:30 pm EST
GSK Consumer Healthcare
184 Liberty Corner Road (also known as Center 78)
Warren, NJ 07059
+1 908 293 4000
Advancing digital health policies is becoming more and more important to the US Food and Drug Administration (FDA). From the launch of a premarket digital safety program and an internal data science incubator, to the release of drafted policies for multi-function device products and a working model for FDA’s digital health Pre-Certification program.
Regulatory considerations for digital health products are top-of-mind for firms interested in developing digital health products. A lack of clarity in requirements creates a landscape where manufacturers are hesitant to innovate. Join others from your local regulatory community to hear an interactive presentation on this important topic.
Feature speakers will describe why a new digital health regulatory paradigm is necessary, and will explore what health authorities are doing to clarify regulatory consideration to provide guidance for industry to enter the digital health market.
The engagement activity, hosted by GSK Consumer Healthcare, is brought to you by the RAPS New York/New Jersey chapter and is intended to promote professional development and networking opportunities in the local regulatory community. A meal will be available to all attendees and RAC holders may claim two RAC recertification credits.
Mike Benecky, PHD senior director, global regulatory affairs, precision and digital medicine, GSK Pharma
Guliz Guler, associate director, regulatory affairs, digital and respiratory, GSK Consumer Healthcare
Prior to 11 April
RAPS Members: $35
On or After 11 April
RAPS Members: $45