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Wednesday, June 27 • 2:00pm - 3:15pm
#358: Expedited E2B Safety Reporting in Interventional Clinical Trials: Convergence of Global Expectations?

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-655-L04-P; CME 1.25; IACET 1.25; RN 1.25

FDA has provided guidance to sponsors on systematic approaches to IND safety reporting that focus on informative reports of important safety information. To enhance the efficiency of this process, FDA has initiated a pilot program for the submission of IND safety reports in a standardized, structured format that follows the ICH E2B standard (with certain regional modifications). Likewise, for expedited clinical trial safety reports in Japan and elsewhere. This forum is designed to provide a balanced discussion of clinical trial electronic case reporting requirements based on audience interest. The forum will include lessons learned from the ongoing US pilot and a comparison with the clinical trials reporting situation in Japan. Each of the expert panel members will provide brief introductory comments and, at the conclusion of prepared remarks, the panel will entertain Q&A.

Learning Objectives

Discuss the importance of providing informative IND safety reports to FDA and high-level requirements for submission of ICSRs in E2B format; Describe the benefits and challenges of implementing structured electronic safety reports from clinical trials in the US and Japan; Outline initiatives in the US and Japan to improve and streamline expedited clinical trial safety reporting.

Chair

William Gregory, PhD

Speaker

Safety Reporting Practices: Current State, Efforts to Streamline the Process, and the Case for a Global Safety Database
Tamy Kim, PharmD

Emerging New PV World: Comparison of and Exploring New Guidelines for Clinical Research in Japan
Teiki Iwaoka

Directional Roadmap for ICSR Data Standards and Harmonized Case Reporting
Ta-Jen Chen, MS

FAERS II
Suranjan De

Industry Perspective
Dieter Kempf, MS


Speakers
avatar for Ta-Jen Chen

Ta-Jen Chen

Project Management Officer, OSP, CDER, FDA
TJ is a project management Officer at Office of Strategic Programs, CDER, FDA, where he is responsible for the development, testing, and implementation of electronic data standards for CDER regulatory review. As a FDA delegate to ICH E2B Expert Working Group and ISO TC 215 WG 6, he... Read More →
avatar for Suranjan De

Suranjan De

Deputy Director, Regulatory Science, OSE, CDER, FDA
Mr. De is the Deputy Director of CDER’s Office of Surveillance and Epidemiology, Regulatory Science Staff at FDA. He provides expert advice and technical direction on regulatory science for developing new tools, standards, and approaches to assess the safety, efficacy, quality... Read More →
avatar for William Gregory

William Gregory

Senior Director, Safety and Risk Management, Pfizer Inc
He received formal training in infectious diseases and molecular mechanisms of pathogenesis and has more than 15 years of experience directing global product development and registration programs. He also has extensive experience in pharmacovigilance and health informatics as well... Read More →
avatar for Teiki Iwaoka

Teiki Iwaoka

Director, Pharmacovigilance, Clinical Development, Nanocarrier Co., Ltd.
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.
DK

Dieter Kempf

Head, Pharmacovigilance Information and Systems, Genentech, A Member of the Roche Group
He is heading the PV Information and Systems group, which is responsible for systems supporting PV processes in the global Roche/Genentech Safety Risk Management organization. His experience also includes the implementation of clinical systems like EDC and thesaurus management, and... Read More →
avatar for Tamy Kim

Tamy Kim

Associate Director for Regulatory Affairs, OHOP and OCE (Acting), CDER, FDA
Tamy Kim is the Associate Director for Regulatory Affairs (ADRA) in the Office of Oncology and Hematology Products (OHOP) and Acting ADRA in the Oncology Center of Excellence (OCE) at the FDA. In OHOP, her responsibilities include developing policies related to review processes, including... Read More →

Wednesday June 27, 2018 2:00pm - 3:15pm
Room 253AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  01: ClinSafety-PV, Forum