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Thursday, July 1 • 2:00pm - 3:00pm
#436 SL: What is the Breakthrough Risk Communications and Assessing Safety After Early Access to Pharmaceuticals?

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-658-L04-P; CME 1.00; IACET 1.00; RN 1.00

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 Objectives

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.


Rie Matsui, RPh


Postmarket Safety Label Changes: Relationship to Development Pathways
Gerald J. Dal Pan, MD, MHS

Communication with Public/Patients to Promote Appropriate use of Medical Products in Japan
Junko Sato, PhD

Patient Labeling: Current State and Future Directions
Meredith Smith, PhD, MPA, FISPE

avatar for Junko Sato

Junko Sato

Director, Office of International Programs, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. Sato joined the Pharmaceuticals and Medical Devices Agency (PMDA) in 1998, and she is currently the Office Director for the Office of International Programs. She has work experiences in new drug review for 11 yrs, risk management for 3 yrs, and international area for 6 yrs. She... Read More →
avatar for Rie Matsui

Rie Matsui

Senior Director, Regional Labeling Head for APAC, Pfizer Inc, Japan
Rie Matsui is Senior Director, Regional Labeling Head for APAC, International Labeling Group, Global Regulatory Science, Pfizer Japan. She is also the Head, External Engagements for ILG. She is the founder of Asia Labeling Hub at Pfizer that has created various local label updates... Read More →
avatar for Meredith Smith

Meredith Smith

Sr Director, Risk Management, Global Patient Safety, Alexion Astra Zeneca Rare Disease, United States
Meredith Smith is Risk Management Director at AstraZeneca where she is responsible for medicinal product benefit-risk management for the Alexion Rare Disease Business Unit portfolio. She is a behavioral scientist and health services researcher by training with over 15 years of experience... Read More →
avatar for Gerald Dal Pan

Gerald Dal Pan

Director, Office of Surveillance and Epidemiology, CDER, FDA, United States
Gerald J. Dal Pan, MD, MHS, is Director of the Office of Surveillance & Epidemiology in FDA’s Center for Drug Evaluation and Research, where he oversees adverse event surveillance and analysis, pharmacoepidemiology, risk management, and medication error prevention. A member of the... Read More →

Thursday July 1, 2021 2:00pm - 3:00pm EDT
TBD Virtual Event Horsham, PA 19044
  01: ClinSafety-PV, Forum