E2B(R3) – Electronic Transmission of Individual Case Safety Reports (ICSRs) – ICH

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E2B(R3) – Electronic Transmission of Individual Case Safety Reports (ICSRs)

In July 2013, the ICH Steering Committee endorsed the establishment of the IWG on E2B(R3) to progress implementation activities and ensure transition from E2B(R2) to E2B(R3). The E2B(R3) Implementation Package, Q&As and further information is available on the ESTRI page.

Related Links

ESTRI page - E2B

Endorsed Documents

E2B(R3) Concept Paper

E2B(R3) Implementation Guide

E2B(R3) Appendix to the Implementation Guide

E2B(R3) Work Plan

WG Presentations / Trainings

E2B(R3) Training Video - Module I

E2B(R3) Training Material - Module II

E2B(R3) Training Material - Module III

Ongoing public consultations

No results found.

E2B(R3) Expert/Implementation Working Group

Rapporteur

Ms. Mariko TsukudaMHLW/PMDA, Japan

Regulatory Chair

Experts

ANVISA, BrazilDr. Mônica da Luz Carvalho Soares

EC, EuropeMr. Tom Paternoster-Howe

EC, EuropeMs. Anja Van Haren

EFPIAMr. Thomas Kuckuk

EFPIAMr. Donald Williams

FDA, United StatesDr. Quocbao Pham

FDA, United StatesDr. Shifu Zhao

Health Canada, CanadaMs. Jamie Rondeau

JPMAMr. Manabu Inoue

JPMAMr. Yujiro Kawasaki

JPMAMs. Miyako Shionoiri

MHLW/PMDA, JapanDr. Takashi Misu

MHLW/PMDA, JapanMr. Takeshi Onohara

NMPA, ChinaMs. Rong Fan

NMPA, ChinaMr. Hongliang Liu

PhRMAMr. Raymond Kassekert

PhRMAMs. Amanda Zirelli

SFDA, Saudi ArabiaMr. Mubarak Alshahrani

Swissmedic, SwitzerlandDr. Stephan Jaermann

TITCK, TürkiyeMs. Hacer Ebru Aydoğan

WHOMs. Helena Sköld

Rapporteur Supporter

Alternate

Ms. Flávia Moreira CruzANVISA, Brazil

Mr. Bill WilsonHealth Canada, Canada

Ms. Nilcan DemirTITCK, Türkiye

Dr. Shanthi PalWHO

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E2F – Development Safety Update Report

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E2D – Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting

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E2D – Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting

Pre-harmonisation

E2D – Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting

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E2D(R1) – Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports

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E2A – Clinical Safety Data Management: Definitions and Standards for Expedited Reporting

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E2B – Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports (ICSRs)

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