Earl Hulihan, VP of Global Regulatory Affairs and Quality Assurance, to
Drive Discussion on Key 2008 Regulatory Initiatives
NEW YORK, December 4 /CNW/ - 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
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
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
For further information:
For further information: Lois Paul & Partners Susan Lombardo,