×
Don't Miss Out!
Get your weekly Breakfast Briefing eNewsletter, filled with news, trends, and vital information from DIA!
Back to Agenda
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, International Labeling
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 Smith, PhD, MPA, FISPE
Evidera, Inc, United States
Senior Director, Implementation Science Pillar Lead
Have an account?