FDA Information Day: Individual Case Safety Reports (ICSR)

Venue: The Kirkland Center At the National Labor College

Location: Silver Springs, Maryland, United States

Event Date/Time: Mar 13, 2012 End Date/Time: Mar 14, 2012
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The FDA is organizing these two Information Day events to provide the latest information about the Individual Case Safety Reports (ICSR) and the Identification of Medicinal Product (IDMP) Standards.

The first part on ICSR will focus on the progress made in developing a new ICSR format by the International Conference on Harmonization (ICH) in collaboration with Standards Development Organizations.

ICH recently agreed to use the International Organization for Standardization (ISO) ICSR standard to meet the reporting requirements for E2B(R3). ICH defines the way that this standard should be used by means of the ICH Implementation Guide (IG), which covers the use of the fields defined by the E2B(R3). The ICH Implementation Guide has been further developed and reached Step 2 in June 2011. This guide has been released for ICH Step 3 public consultation. There are significant differences between the data models for E2B(R2) and E2B(R3), and a Backwards and Forwards Compatibility (BFC) document has been produced as an appendix to the Implementation Guide which defines the compatibility of data elements between the two versions of the specification.

The second part will focus on the IDMP standards, which were developed in response to a worldwide demand for internationally harmonized specifications for exchanging medicinal product information in a robust and reliable manner. The IDMP standards support the regulation of medicines and pharmacovigilance including ICSR.

At the ISO TC 215 meeting in May 2011, the resolution was adopted that the IDMP progresses to Final Draft International Standard (FDIS), a major step forward in finalizing the five IDMP standards by mid-2012.

The two 1.5-day Information Day events will be held back to back, allowing you to choose one or both to best suit your educational needs.

Learning Objectives:
At the conclusion of this meeting, participants should be able to:
• Understand the ongoing international standardization work on ICSR and IDMP
• Recognize the main new features of the ICSR and IDMP standards
• Prepare for the implementation of the new ICSR and IDMP standards for adaptation in pharmacovigilance systems

Target Audience:
Professionals involved in:
• Clinical research and development/Clinical supplies
• Clinical safety and pharmacovigilance
• Electronic regulatory submissionsDocument management
• Information technology
• Regulatory affairs

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