Clinical and Regulatory Affairs
"Navigating the Regulatory Waters"
February 6, 2015
All sessions will take place in 517 Bldg., 137A (Large) Lecture Hall
517 Bldg ~ 147 Classroom
8 - 9 a.m. CRA Day Launch with Dave Pizzuti
Dave Pizzuti - Vice President, Regulatory Affairs Gilead will
be discussing CRA opportunities
9 - 11:45 a.m. CRA Career Fair
Angela Cossey will be featuring "Tips on Job/Internship Hunt"
plus representatives from:
~ City of Hope
~ Edwards Lifesciences
NOTE: The Career Fair will start off in Room 147, and then will move over to the Large Lecture Hall to mingle with industry representatives.
517 Bldg ~ 137A Large Lecture Hall
12:00 - 12:15 p.m. Focus Friday Check-In
12:15 - 12:30 p.m. CRA Focus Friday “Welcome" and Opening Remarks
Professor of Practice, Clinical and Regulatory Affairs
President of KGI
12:30 – 1:30 p.m. Lunch & Keynote Speaker
"Regulatory Affairs - Evolving Disciplines: Regulatory
Research and Patient Engagement"
Senior Director, Regulatory Affairs, BioMarin
1:30 – 2:15 p.m. "Many Roles of Quality and the Quality Manager Role"
Manager, Quality , Edwards Lifesciences
2:15 – 3:00 p.m. Donna Saito
Principal Regulatory Affairs Specialist, Medtonic, Inc.
3:00 - 3:30 p.m. Break & Networking
3:30 – 4:15 p.m. "Regulatory Challenges in Translational Research"
Director of the Office of IND Development and Regulatory
Affairs (DIDRA), City of Hope
4:15 – 5:15 p.m. Panel Discussion
KGI Alumni working in Clinical & Regulatory Affairs
5:15 p.m. Wrap-Up
When & Where
Keck Graduate Institute