Loading…
This event has ended. Visit the official site or create your own event on Sched.

Wednesday, June 29 • 4:00pm - 5:00pm
#371: FDA and PatientsLikeMe: Exploring the Use of Patient-Generated Data in Drug Safety

Sign up or log in to save this to your schedule and see who's attending!

Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-16-581-L05-P; CME 1.00; IACET 1.00; RN 1.00

PatientsLikeMe and FDA have a research collaboration agreement to explore how patient-reported data can give new insights into drug safety. In this session, we will discuss the objectives, agenda, progress, and findings from our early research.

Learning Objectives

Discuss the evolving research goals and findings from the collaboration between FDA and PatientsLikeMe; Outline identified applications of patient-generated data in a regulatory context to inform pharmacovigilance, pharmaco-epidemiology, medication error, and risk management efforts.

Chair

Ben Heywood, MBA

Speaker

Patient-Generated Data in Drug Safety
Ben Heywood, MBA

Systematic Exploration of Patient-Generated Health Data for Use in Postmarketing Safety Monitoring
Carol A Pamer

FDA Perspective
Sonja Brajovic, MD



Chair
avatar for Ben Heywood

Ben Heywood

President and Co-Founder, PatientsLikeMe
As President and Director of PatientsLikeMe, Benjamin Heywood is responsible for setting the company vision to improve healthcare and accelerate research, while directing its business growth strategy. Inspired by his brother Stephen’s battle with ALS, Heywood co-founded the company... Read More →

Speakers
avatar for Sonja Brajovic

Sonja Brajovic

Medical Officer, Office of Surveillance and Epidemiology, CDER, FDA
Sonja Brajovic is a Medical officer in the Office of Surveillance and Epidemiology (OSE), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA). She is responsible for coordination of projects related to the Medical Dictionary for Regulatory Activities... Read More →
CP

Carol Pamer

Program Lead for Pharmacovigilance, OSE, CDER, FDA
Carol Pamer is Program Lead for Pharmacovigilance in the FDA CDER Office of Surveillance and Epidemiology (OSE) Regulatory Science Staff. She is a Principal Investigator for the FDA-PatientsLikeMe Research Collaboration Agreement. She earned her B.S. degree in Pharmacy from Ohio State... Read More →


Wednesday June 29, 2016 4:00pm - 5:00pm
113A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA