10 November 2016
5:30–8:30 pm PT
Johnson & Johnson
Fremont, CA
Personalized medicine, such as the use of companion diagnostics tests, is transforming the way medicine is practiced. These tests are important tools to improving patient outcomes and helping doctors identify patients who are more likely to respond positively to treatments. However, the development and validation of companion diagnostics in collaboration with pharmaceutical companies come with some challenges in our regulated industries.
The RAPS San Francisco Bay Area Chapter invites you to spend an evening with your colleagues as we review the implications of the recently issued FDA draft guidance on the co-development of a therapeutic product and diagnostic. Get insight to some of the challenges in bringing companion diagnostics into the market and find out how the new draft guidance will impact development from a diagnostics manufacturer's perspective. A light meal will be available and attendees may claim two RAC recertification credits.
A valid photo identification will be required to enter the premises. Participants will not be able to gain access without a photo ID.
Date/Time:
Thursday, 10 November 2016
5:30–6:30 pm Registration Check In, Networking and Dinner
6:30–7:15 pm Speaker Presentation
7:15–8:00 pm Discussion and Q/A Session
8:30 pm Program Concludes
Location:
Johnson & Johnson
6500 Paseo Padre Parkway
Fremont, CA 94555
Get directions online, or call +1 510 248 2500
Registration:
Prior to 4 November:
RAPS Members: $25 Nonmembers: $35
On or after 4 November:
RAPS Members: $35 Nonmembers: $45
» Registration Form (PDF) - for registration by mail or fax.
You can also register by calling +1 301 770 2920, ext. 200.
Featured Speaker:
Lesley Farrington, director, regulatory affairs, Roche Molecular Systems
Local Contact:
Shweta Kaushik, PhD, RAC, registraton chair, RAPS San Francisco Bay Area Chapter
RAPS Contact:
Wesley Carr, senior manager, chapter and volunteer relations, RAPS, +1 301 770 2920