NY/NJ Chapter: Digital Regulatory Considerations in Pharma and Consumer Healthcare

When:  Apr 18, 2019 from 5:30 PM to 8:30 PM

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

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

Feature Speakers

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

Registration Information:
Prior to 11 April
RAPS Members: $35
Nonmembers: $50

On or After 11 April

RAPS Members: $45
Nonmembers: $60



184 Liberty Corner Rd
Warren, NJ 07059-6796