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

Regulator
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Date & Time Date: Time: Duration: Host(s):

Tue, Sep 13, 2011 10:00 AM EDT 1 hour BioPharm Systems / Oracle Health Sciences

Presenter Information
Rodney Lemery, Ph.D.

Meeting Description: 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 worlds population. These companies include pharmaceutical, biotech, medical device, contract research organisations (CROs), charitable and not-forprofit 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

Rodney Lemery specializes in the implementation, support, and development of software used in the collection, management, and analysis of clinical data. His accomplishments as senior director of safety management at BioPharm Systems include the management of numerous clinical application implementation projects. In addition to his expertise in clinical applications, Rodney is able to navigate between the technical and clinical worlds with ease due to his complementary educational background in epidemiology. He also holds a part-time professorship in the School of Health Sciences at Walden University, which solidifies his ability to lead global safety implementations at BioPharm Systems. Prior to joining the company in 2000, Rodney was a systems analyst at Pfizer.

Adrian Hampshire

As managing director, Adrian Hampshire leads BioPharm Systems' Europe, Middle East and Africa business unit. He brings over 30 years of information technology experience and two decades of proven innovation and execution in clinical trials with which he helps organizations to realize the value of clinical trials systems. He applies his communication and relationshipbuilding skills to identify and deliver solutions that fit clients' needs. Prior to joining BioPharm

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 Register for this Meeting:
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Systems, Adrian was EMEA Director at CSS Informatics and worked for a number of pharmaceutical and biotechnology companies throughout his career.

Paul Dobrowolskyj

For the past 12 years, Paul Dobrowolskyj has been concentrating on drug safety systems. As senior consultant in the Oracle Health Sciences Global Business Unit, he specializes in Oracles safety and pharmacovigilance solutions. Paul has been with the company since 2008 and prior to joining Oracle, he was a consultant and project manager at Relsys International. Paul currently works throughout Europe and is a frequent speaker on business and IT issues that drug safety departments around the world face.

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