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Electronic Reporting of ICSRs & EudraVigilance

 
  January 17, 2008  
     
 
Drug Information Association, DIA, 800 Enterprise Rd., Suite 200, Horsham, PA, USA
Mar 31 2008


This course is designed for people in charge of Pharmacovigilance and drug safety with legal reporting obligations in the EEA, as well as professionals working in Pharmacovigilance, data entry, medical coding, and dictionary and data management. This course would also benefit individuals interested in updating their knowledge of electronic adverse reaction reporting, and pharmaceutical companies and sponsors of clinical trials in the US that:• Perform electronic transmission of ICSRs and wish to obtain insight in the practical use of the ICH E2B(M), ICH M2 and MedDRA standards• Intend to use EVWEB and or the integrated gateway component (Web Trader) to implement electronic transmission of ICSRs in the EEA• Have to meet the requirement in the EEA to provide core medicinal product information in the EudraVigilance Medicinal Product Dictionary (EVMPD)• Wish to get hands-on experience in working with the ICH standards based on EVWEB and learn about the functionalities available.
 
 
Organized by: Drug Information Association
Invited Speakers:

1) William W. Gregory, PhDDirector, Safety and Risk ManagementPfizer IncUnited States. 

2) Calin A. Lungu, MDCEODrug Development Consulting Services S.A. (DDCS)Luxembourg.

 
Deadline for Abstracts: -
 
Registration: http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspx?productID=16028&eventType=EudraVigilance
E-mail: dia@diahome.org
 
   
 
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