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What is the Breakthrough Risk Communications and Assessing Safety After Early Access to Pharmaceuticals?
Session Chair(s)
Rie Matsui, RPH
Senior Director, Regional Labeling Head for APAC, Pfizer R&D Japan G.K., Japan
The principle of patient-centric labeling and assessing safety will be discussed to seek an opportunity for international harmonization for implementing earlier access to medicines as the breakthrough risk communication.
Learning Objective : Describe the current challenges for risk communication to patients across regions; Identify the future breakthrough risk communication to patients and principle of patient-centric labeling; Discuss how to assess safety after early access to Pharmaceuticals; Discuss how to measure the effectiveness of risk communication/patient-centric labeling.
Speaker(s)
Gerald Dal Pan, MD, MHS
Director, Office of Surveillance and Epidemiology, CDER, FDA, United States
Postmarket Safety Label Changes: Relationship to Development Pathways
Junko Sato, PHD
Associate Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Communication with Public/Patients to Promote Appropriate use of Medical Products in Japan
Meredith Yearsley Smith, MPA, FISPE
Fellow and faculty member, USC Alfred E. Mann School of Pharmacy and Pharmaceutical Sciences, United States
Patient Labeling: Current State and Future Directions
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