FDA Information Day: The New Individual Case Safety Report (ICSR) International Standard and ICH E2B


Date(s) And Time(s):
May 12 2011 8:00AM - May 13 2011 5:00PM

Join Representatives from FDA and EMA to Discuss the Implications of the ICH Guideline for Clinical Safety Data Management

In May 2005, the revised ICH Guideline for Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports (ICSRs) (E2B(R3)) was released for public consultation. The ICH Steering Committee decided that technical specifications should no longer be developed solely within ICH, but should be created in collaboration with Standards Development Organisations (SDOs) to enable wider interoperability across the regulatory and health care communities. The ICSR is the first topic to go through this process. ICH representatives have been heavily involved in this initiative in addition to other experts from beyond the ICH community. The overall standard is based upon the HL7 ICSR model that is capable of supporting a wide range of product types (e.g., human medicinal products, veterinary products, medical devices, etc.)

ICH proposed to use this standard to meet the reporting requirements for E2B(R3). ICH will define the way that this standard should be used by the publication of an ICH Implementation Guide, which will define the use of the data elements as outlined in the E2B(R3) guideline. In addition, a harmonized approach to ensure backwards and forwards compatibility between the current ICH ICSR message specifications and the new standard – a major aspect during the transition phase until all stakeholders have upgraded their pharmacovigilance systems – will be addressed in the Implementation Guide.

This day and a half workshop will explore how a single, common standard for the ICSR could be advanced.

• Status of International Standardization of Clinical Safety Data Management
• Current ICH E2B(R2) Guideline and the HL7 Message Specifications
• How to Adapt the the New ICSR Standard to Your Pharmacovigilance Systems

Learning Objectives:
At the conclusion of this course, participants should be able to:
• Discuss the ongoing international standardization work
• Recognize the main changes in comparison to the current ICH E2B(R2) guideline and the HL7 message specifications
• Prepare for the implementation of the new ICSR standard for adaptation in their pharmacovigilance systems

Target Audience:
Professionals involved in:
• Clinical Research & Development/Clinical Supplies
• Clinical Safety & Pharmacovigilance
• Electronic Regulatory Submissions/Document Management
• Information Technology
• Regulatory Affairs

Event Code:


Event Information: Contact Melissa Matta at the DIA offi ce by telephone
215.442.6158, fax 215.442.6199 or email Melissa.Matta@diahome.org.