Skip to NavigationSkip to content

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


Thursday, April 28, 2011
Webinar
Webinar, United States

https://cc.readytalk.com/r/7yj52941l079

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

Mission Statement
Pharmafile.com is a leading portal for the pharmaceutical industry, providing industry professionals with pharma news, pharma events, pharma service company listings and pharma jobs,
Site content is produced by our editorial team exclusively for Pharmafile.com and our industry newspaper Pharmafocus. Service company profiles and listings are taken from our pharmaceutical industry directory, Pharmafile, and presented in a unique Find and Compare format to ensure the most relevant matches