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Argus Safety: Planning for the New Individual Case Safety Report (ICSR) International Standard and Upcoming ICSR Reporting Changes

Thursday, April 28, 2011
Webinar, United States

Event Type: Seminar

The new ISO Individual Case Safety Report (ICSR) standard is being finalized in 2011. A major revision of the ICH E2B guideline is progressing based on the new ICSR standard with an ICH step 2 consultation of the ICH E2B(R3) Implementation Guide expected by the end of June 2011. An overview of the proposed changes to the ICSR Final Draft International Standard (FDIS) and its implementation will be discussed, along with the expected changes to the ICSR reporting in the context of the new European pharmacovigilance legislation.

Join BioPharm Systems' Andrew Mitchell, EMEA safety and pharmacovigilance practice lead, for this one-hour presentation that will include:

  • Discussion of the upcoming ISO Individual Case Safety Report (ICSR) standard known as ICH E2B(R3)
  • Electronic reporting of ICSRs and EudraVigilance in the context of the new European pharmacovigilance legislation
  • Using Argus Safety to comply with the information and regulations above and how this affects your upgrade planning

Thursday, April 28, 2011 @

9:00 a.m. Pacific
10:00 a.m. Mountain
11:00 a.m. Central
12:00 p.m. Eastern
5:00 p.m. GMT

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