Released on: June 18, 2008, 11:16 am

Press Release Author: GTC Bio

Industry: Biotech

Press Release Summary: Peter Mayne, QA Manager of OSI Pharmaceuticals will be
speaking at GTCbio's Global Clinical Trial Operations conference on September 25-26,
2008 in San Diego, CA. Dr. Mayne will present on being an EU Qualified Person (QP)
as a small offshoot of a virtual company.

Press Release Body: Since the introduction of the EU Clinical Trials Directive in
2004 it has been a requirement within Europe for investigational medicinal products
to be "certified" by a Qualified Person (QP) before they are used in a clinical
study. This talk will cover the role and responsibilities of the QP from the
perspective of a virtual US-based company with a single QA representative in the
U.K., concentrating on how the QP puts themselves in a position to certify that all
manufacturing operations are performed to standards equivalent to EU GMPs and in
accordance with European regulatory submissions. The presentation will cover common
US misunderestimations of the role of the QP and other potential pitfalls for
companies in similar positions.

The Global Clinical Trial Operations conference brings together leaders, directors,
vice presidents, heads, managers, supervisors, and CROs from all over the world to
collaborate and discuss the latest developments in clinical trial operations and
logistics and covers clinical trials in emerging markets, first-in-man clinical
trials, pediatric clinical trials, material storage, distribution, site selection,
patient recruitment and retention, technology in clinical trials and case studies of
running global clinical trials.

For more information including a detailed agenda, exhibitor opportunities and
registration information visit http://gtcbio.com/conferenceDetails.aspx?id=127.

ABOUT GTCbio

GTCbio organizes conferences specifically for the biomedical and biopharmaceutical
industries. Our goal is to facilitate the exchange of biopharmaceutical and
biomedical intelligence between industry leaders, academic and government
organizations, and the financial community.
GTCbio is a subsidiary of Global Technology Community, LLC, a privately held company
founded in 2002.


Web Site: http://gtcbio.com/conferenceDetails.aspx?id=127

Contact Details: 434 W. Foothill Blvd.
Monrovia, CA 91016
Tel: (626) 256-6405
fax: (626) 256-6460
email: nina.tran@gtcbio.com