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Oracle Argus Safety and Oracle Argus Safety Japan: A Unified Solution that Facilitates Compliant Reporting to a Japanese Regulator

Submitted by Anonymous on Thu, 06/16/2011 - 12:24
09/13/2011 3:19 pm
Europe/London

Achieving complete and efficient reporting of adverse drug reactions is a critical goal for all companies involved in developing and delivering medicinal products to the world’s population. These companies include pharmaceutical, biotech, medical device, contract research organisations (CROs), charitable and not-for-profit organisations and academic institutions.

While the challenge of efficient and effective safety reporting to two of the major regulatory agencies – FDA and EMA – is substantial, the additional challenge of reporting to the Japanese regulatory authority, the PMDA, in a way that integrates with an existing safety reporting process and function is significantly greater.

Argus Safety and Argus Safety Japan together help you to meet these challenges by providing a single global database and integrated workflow process for superior safety reporting capabilities.

This webinar will be of interest and relevance to all organisations that need a robust and proven safety system to meet their global regulatory reporting requirements. It will be of particular interest to those companies that have a requirement to report safety events to the PDMA in Japan in a timely and efficient manner that is integrated within their global safety reporting functions.

This webinar will provide you with:

-An overview and the business benefits of Oracle Argus Safety Suite
-The business benefits of Oracle Argus Safety Japan and integrating it with Oracle Argus Safety
-The benefits of a single global safety database and why Oracle Argus Safety Suite is the right solution for it

Tuesday, September 13, 2011 @:

7:00 a.m. US Pacific time
8:00 a.m. US Mountain time
9:00 a.m. US Central time
10:00 a.m. US Eastern time
15:00 UK time
16:00 Central European time

Webinar Presenters: 
Rodney Lemery, Adrian Hampshire, Paul Dobrowolskyj
Webinar URL: 
Register
Your rating: None Average: 5 (1 vote)
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Tags:
  • adverse events
  • AERS
  • argus safety
  • Argus Safety Japan
  • biopharm systems
  • business
  • clinical research organizations
  • Clinical Trials
  • cloud computing
  • drugs safety
  • IT
  • Oracle
  • Oracle Argus Safety
  • pharma biotech
  • Pharmacovigilance
  • software


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