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Topics Related to Japan [clear filter]
Tuesday, June 28
 

2:00pm EDT

#249: Current Topics for Pharmacovigilance in Japan
Limited Capacity seats available

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



Chair
avatar for Stewart Geary

Stewart Geary

Senior Vice President, Chief Medical Officer, Eisai Co., Ltd.
Stewart Geary has worked at Eisai since 1996 in PV, clinical safety and regulatory science. He was a member of the CIOMS VII, VIII and IX Working Groups, and currently serves on the Executive Committee of JAPhMed and the Editorial Advisory Boards for Applied Clinical Trials and Pharmaceutical... Read More →

Speakers
avatar for Teiki Iwaoka

Teiki Iwaoka

Executive Consultant, Director of Drug Safety Outsourcing Planning, CAC Croit Corporation
Drug Safety & Pharmacovigilance expert. EWG for ICH E2B, and Rapporter for ICH E2D. Lecturer of many educational seminars worldwide more than 20 years. Executive Consultant, and Auditors for Global Pharmacovigilance Compliance.
avatar for Naohiro Otaki

Naohiro Otaki

Technical Officer, Application Review Division I, Office of Relief Funds, Pharmaceuticals and Medical Devices Agency (PMDA)
Technical officer of PMDA since Feb.2010 and technical officer of Office of Relief Funds of PMDA since Jan. 2014.


Tuesday June 28, 2016 2:00pm - 3:15pm EDT
113B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 14: Clin Safety/PV, Session

4:00pm EDT

#277: PMDA Town Hall
Limited Capacity seats available

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



Chair
avatar for Toshiyoshi Tominaga

Toshiyoshi Tominaga

Associate Executive Director (for International Programs), Pharmaceuticals and Medical Devices Agency (PMDA)
Dr. Tominaga is Associate Executive Director for International Programs. He supervises the overall strategy and conduct of international operations by PMDA. He joined MHLW after acquired PhD from Faculty of Pharmaceutical Sciences, the University of Tokyo. As a career official, he... Read More →

Speakers
avatar for Tatsuya Kondo

Tatsuya Kondo

Chief Executive, Pharmaceuticals and Medical Devices Agency (PMDA)
Dr. Tatsuya Kondo is Chief Executive of PMDA since 2008. He spent most of his career as a neurosurgeon after his graduation from the University of Tokyo in 1968. He has various experiences including a hospital doctor, a fellowship in Max-Planck Institute for brain tumor research... Read More →
avatar for Nobumasa Nakashima

Nobumasa Nakashima

Director, Office of International Regulatory Affairs, Ministry of Health, Labour and Welfare (MHLW)
Dr. Nakashima joined Pharmaceutical and Food Safety Bureau of Ministry of Health, Labor, and Welfare in 1992. He spent his career in the international field such as at WHO and OECD, not only in the domestic field. He has been Director of the Office of International Programs, PMDA... Read More →
avatar for Tomiko Tawaragi

Tomiko Tawaragi

Chief Safety Officer, Pharmaceuticals and Medical Devices Agency (PMDA)
Ms.Tomiko Tawaragi is in position of the Chief Safety Officer of PMDA since July 2014. She is responsible for post-marketing safety measures and GMP/QMS for pharmaceuticals and medical devices. She spent most of her careear as a technical officer of Ministry of Health, Labour and... Read More →


Tuesday June 28, 2016 4:00pm - 5:15pm EDT
202AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 18: Global Regulatory, Forum