Who: Rodney Lemery, Ph.D., director of safety management, BioPharm Systems
Adrian Hampshire, managing director, EMEA, BioPharm Systems
Paul Dobrowolskyj, senior consultant, Oracle Health Sciences
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 organizations (CROs), charitable and not-for-profit organizations 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 organizations 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
When: 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
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 (Siebel Clinical), drug safety and pharmacovigilance (Argus Safety and Adverse Event Reporting System), clinical data warehousing and analytics (Life Sciences Data Hub and Clinical Development Analytics), clinical data management (Oracle Clinical), and electronic data capture (Remote 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 the United Kingdom. To learn more about the company’s products and services, please call +1 877 654 0033 or e-mail firstname.lastname@example.org.
BioPharm Systems is an Oracle Accelerate partner and a Gold member in Oracle PartnerNetwork.
Follow BioPharm Systems on Twitter (www.twitter.com/
North America Sales Contact:
+1 877 654 0033
Europe/Middle East/Africa Sales Contact:
+44 (0) 1865 910200
+1 617 795 2032