BioPharm Systems

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Oct 7

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

by Eugene Sefanov

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

View a recording of the webinar at https://cc.readytalk.com/r/1arwmwvagd2p.

For more information about BioPharm Systems, please visit www.biopharm.com.