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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)
Postmarket Safety Label Changes: Relationship to Development Pathways
Gerald Dal Pan, MD, MHS
FDA, United States
Director, Office of Surveillance and Epidemiology, CDER
Communication with Public/Patients to Promote Appropriate use of Medical Products in Japan
Junko Sato, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Associate Executive Director
Patient Labeling: Current State and Future Directions
Meredith Yearsley Smith, PhD, MPA, FISPE
USC Alfred E. Mann School of Pharmacy and Pharmaceutical Sciences, United States
Fellow and faculty member