DIA 2016 Annual Meeting

Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

Did you know that Japan has a relief system for adverse reactions which makes payments to patients who have suffered adverse reactions during use of drugs for their approved indications? Are you aware of the many actions taken recently in Japan for under-reporting or missed reporting of adverse reactions by domestic and foreign-headquartered pharmaceutical companies? Do you struggle to understand the requests of your Japanese partners and colleagues related to managing pharmacovigilance and adverse reaction report exchange in that country? Have you ever been overwhelmed by solicited cases from Japanese observational studies or had trouble interpreting the results of all-case surveillance studies from that country? This session aims to give a full background on the postmarketing surveillance system in Japan including the re-examination and re-evaluation systems, the role of observational studies and the current practices in risk management. The session will also examine recent cases of non- or under-reporting of ICSRs and the possible connection between complexity of PV regulation, the multitude of ways in which safety information can reach pharmaceutical companies and unintentional noncompliance with reporting regulations. Finally, since 1980 Japan has had a Fund for Relief Services for Adverse Drug Reactions. The details of the system and how it serves as a safety net will be described.

Learning Objectives

Discuss how the complexity of pharmacovigilance regulation can be a factor in non- or under-reporting of ICSRs; Describe the regulatory and legal context for pharmaovigilance in Japan; Recognize the different varieties of Japanese postmarketing observational studies and how they are performed; Interpret Japanese pharmacovigilance regulations and expectations; Explain the Relief System for Adverse Reactions in Japan, how it operates and is funded, and its practical effects on patients.

Chair

Stewart Geary, MD

Speaker

Observational Studies in Japan and Asia
Stewart Geary, MD

Relief Services in Occurrence of Serious Adverse Drug Reactions
Naohiro Otaki

Root Cause Analysis of and Solutions for Under Reporting Safety Information of ICSRs in Clinical Research and Sales Activities
Teiki Iwaoka, PhD, MS

Component Type: Forum
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

The progress of the Pharmaceuticals and Medical Devices Agency (PMDA) International Strategic Plan 2015, which was announced after the success of shortening the review period for medicines products, will be presented and will include audience Q&A.

Learning Objectives

Discuss the latest Pharmaceuticals and Medical Devices Agency's (PMDA) activities and direction on Japanese pharmaceutical regulation; Recognize the PMDA’s challenges under the international regulatory environment.

Chair

Toshiyoshi Tominaga

Speaker

Panelist
Tatsuya Kondo, MD, PhD

Panelist
Tomiko Tawaragi

Panelist
Nobumasa Nakashima, PhD