WHAT: “Argus Safety: Planning for the New Individual Case Safety Report (ICSR) International Standard and Upcoming ICSR Reporting Changes”
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
WHEN: 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
WHERE: To participate in this free webinar, please register at: https://cc.readytalk.com/
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About BioPharm Systems
BioPharm Systems (http://www.biopharm.com) is an IT consulting company that focuses on the life sciences industry. We have extensive experience in the implementation, integration, migration, and hosting of Oracle's clinical trial management, drug safety and pharmacovigilance, clinical data warehousing and analytics, clinical data management, and electronic data capture systems. Our products and services help accelerate the development of new drugs, devices, and other therapies.
Founded in 1995 and headquartered in California, BioPharm Systems has offices in the United States and United Kingdom.
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+1 877 654 0033
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