Medidata Solutions to Lead Session on Red Apple II at DIA European Validation Workshop
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.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