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

1. Argus Safety: Planning for the New Date & Time
Individual Case Safety Report Date: Thu, Apr 28, 2011
(ICSR) International Standard and Time: 12:00 PM EDT
Duration: 1 hour
Upcoming ICSR Reporting Changes Host(s): Andrew Mitchell
Please register for this meeting.
Presenter Information
Andrew Mitchell
Meeting Description:
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 Andrew Mitchell has specialized in clinical
systems most of his career. As BioPharm
context of the new European pharmacovigilance
Systems' EMEA safety and
legislation. pharmacovigilance practice lead, he is
responsible for management of Oracle
Join BioPharm Systems' Andrew Mitchell, EMEA safety Argus implementation, migration, and
and pharmacovigilance practice lead, for this one-hour integration projects. Prior to joining
presentation that will include: BioPharm Systems, Andrew led Argus
Safety implementation projects for top life
sciences companies at Relsys
 Discussion of the upcoming ISO Individual Case International and Rave EDC study setups
Safety Report (ICSR) standard known as ICH while at Medidata.
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