Medidata Solutions to Lead Session on Red Apple II at DIA European Validation Workshop
FOR IMMEDIATE RELEASE
Medidata Solutions to Lead Session on Red Apple II
at DIA European Validation Workshop
Earl Hulihan, VP of Global Regulatory Affairs and Quality Assurance, to
Drive Discussion on Key 2008 Regulatory Initiatives
NEW YORK, NY – December 4, 2007 – Medidata Solutions, a global provider of electronic clinical data capture, management and reporting solutions, today announced that Vice President of Global Regulatory Affairs and Quality Assurance Earl Hulihan will co-chair a workshop and present during two sessions at the DIA European Validation Workshop in Amsterdam, The Netherlands:
DIA 6th Annual European Validation Workshop
December 6–7, 2007 Amsterdam, The Netherlands
Session Title: “The Basis for Regulations in China: Chinese GXPs—A Basic Primer on
Laws, Rules, Experiences and Anecdotes”
Date & Time: December 6, 2007 at 10:00–10:30 a.m.
Session Title: “Peach: The New Global Clinical Initiative on Computerized Systems in
Clinical Research: Current Quality and Data Integrity Concepts”
Date & Time: December 6, 2007 at 1:30–3:00 p.m.
The 6th DIA Validation Workshop in Europe will focus on global standards on quality compliance and risk management. The meeting will address both the regulatory and practical aspects of risk management, validation and data integrity as well as current trends and initiatives.
As a program chair, Hulihan will deliver a presentation focused on the regulatory environment in China. Additionally, Hulihan will lead a session on the Red Apple II initiative and its effects on the various industries involved with clinical research. Combining perspectives from the regulatory and pharmaceutical industries, Hulihan will foster a discussion on several key topics related to computer systems and data integrity quality initiatives. These include an update on the Red Apple II text being published by the DIA, the new Global Clinical Initiative (Peach) and validation issues surrounding major organizational changes.
For background information about Medidata executives, please visit
http://www.mdsol.com/about/team_management.htm.
About Medidata Solutions Worldwide
Medidata Solutions helps the world’s leading pharmaceutical, biotechnology, medical device and research organizations maximize the value of their clinical research investments. Innovative process design, technology and services streamline clinical trials by providing early visibility to reliable clinical data—the lifeblood of every research organization. Working with companies and institutions both large and small, Medidata Solutions helps clinical researchers safely accelerate the process of bringing life-enhancing treatments to market—on six continents and in more than 80 countries. Medidata Solutions brings significant value to its broad client base with deep clinical experience and expertise in more than 20 therapeutic areas, projects in Phase I, II, III, IV, registries and surveillance, and studies with thousands of investigators and tens-of-thousands of subjects. For more information, please visit www.mdsol.com.
Contact:
Susan Lombardo
Lois Paul & Partners
781.782.5767
Susan_Lombardo@lpp.com