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DIA 2021 Global Annual Meeting


What is the Breakthrough Risk Communications and Assessing Safety After Early Access to Pharmaceuticals?

Session Chair(s)

Rie  Matsui, RPh

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 J. Dal Pan, MD, MHS

Postmarket Safety Label Changes: Relationship to Development Pathways

Gerald J. Dal Pan, MD, MHS

  • Director, Office of Surveillance and Epidemiology, CDER
  • FDA, United States
Junko  Sato, PhD

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
Meredith  Smith, PhD, MPA, FISPE

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