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DIA 2021 Global Annual Meeting
What is the Breakthrough Risk Communications and Assessing Safety After Early Access to Pharmaceuticals?
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.
Postmarket Safety Label Changes: Relationship to Development Pathways
Gerald J. Dal Pan, MD, MHS
- Director, Office of Surveillance and Epidemiology, CDER
- FDA, United States
Communication with Public/Patients to Promote Appropriate use of Medical Products in Japan
Junko Sato, PhD
- Director, Office of International Programs
- Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Patient Labeling: Current State and Future Directions
Meredith Smith, PhD, MPA, FISPE
- Director, Risk Management, Global Drug Safety, Research and Development
- Alexion Pharmaceuticals, United States