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FOR IMMEDIATE RELEASE
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NEW INTERNATIONAL TRANSPORT REGULATIONS TO RESHAPE
CLINICAL TRIAL PRACTICES
STAMFORD, Connecticut, December 10, 2003—An expert panel of speakers representing the
transportation industry, pharmaceutical practitioners, and international health
and regulatory bodies briefed 250 of the world’s foremost clinical trial
researchers on impending regulatory changes that will affect the packaging and
shipping of diagnostic and infectious substances at World Courier’s recent International
Transportation Bioseminar held in Basel, Switzerland.
Moderator for the one-day
event was Mr. Sergio Benassai, Chairman of the U.N. Subcommittee of Experts on
the Transport of Dangerous Goods. Mr. Benassai was joined at the podium by:
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Dr. Nicoletta Previsani, World Health Organization
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Ms.
Judith Code, Chairman of ICAO’s Dangerous Goods Panel
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Dr.
Didier Guilhem, Senior Research Scientist, Aventis Pharma
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Mr.
Maxence Wittebolle, General Manager, Belgian Packing
Institute
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Mr.
Remy A. Rodas, Esq., Curtis, Mallet-Prevost, Colt & Mosle
LLP
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Dr.
Melanie Saville, Director of Virology, Wyeth Vaccine
Research
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Dr.
Mikhail Samsonov, Medical Director, Central and Eastern
Europe for
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Mr.
Michael T. Sweeney, Director of Development &
Compliance for World Courier Inc.
“As clinical trials are
undertaken in increasingly diverse locations worldwide, it is imperative that
the regulations governing the transportation of biological specimens –
particularly infectious substances – be continuously revised, clarified and
communicated,” says Wayne B. Heyland, President and Chief Executive Officer of
World Courier Group. “Classifications must be objective and unambiguous, and
handling procedures must be strictly controlled, documented and enforced.”
“Ensuring international
compliance with changing regulations is a huge challenge since today’s global
study will typically involve a variety of organizations in a variety of
industries operating in many different countries. Our international bioseminars
are instrumental in bringing together professionals from all sides to discuss
these important issues and determine how universal compliance can be best
realized,” explains Mr. Heyland. “Without far-reaching compliance, the
transportation of biological specimens becomes more costly and complicated.”
To date, World Courier has
hosted eight of these high-level seminars: Brussels, Belgium (1996 and 1998);
London, U.K. (1998); Buenos Aires, Argentina (1999); Sydney, Australia (2000);
Miami, Florida (2001); Singapore, Singapore (2002); and Basel, Switzerland
(2003).
The
specific regulatory changes that will come into effect January 1, 2005 relate
to the four former Risk Group classifications which will give way to three new
designations: Category A (highly infectious, including Risk Group IV substances
and cultures), Category B (all other diagnostic specimens and those containing
Risk Group II and III pathogens), and “Not Regulated” (blood/tissue/organs
etc., collected for transfusion/transplant).
“If risk is to be
minimized, if people are to be protected, and if clinical trials are to come in
on time and on budget, it is critical that all parties associated with the
transportation of biological substances – from the regulatory agencies
overseeing transportation practices to the lab personnel, couriers and airline
staff who actually handle the shipments – become fully familiar with and adhere
to the proper packing and shipping practices,” says Mr. Heyland.
Incorporated in 1969,
World Courier has set the benchmark for worldwide time-sensitive
transportation. It remains the only specialist courier company with its own
global network dedicated to treating every shipment on an individual, priority
basis. Today, World Courier is the acknowledged leader in delivering customized
solutions and value-added services in growth markets such as the bio-medical,
automotive and high-tech industries. Headquartered in Stamford, Connecticut,
World Courier maintains a comprehensive international network of over 130
wholly-owned offices operating in 48 countries around the globe.
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Contacts
North America
Dennis Tselentis
Executive Vice President, Marketing and Sales
World Courier Inc.
1313 - 4th Avenue
New Hyde Park, NY, 11040
Telephone: (516) 354-2600
Toll-free: 1-800-231-7227
Fax:
(516) 354-2713
E-mail:
dtselentis@worldcourier.com
Europe,
Middle East & Africa
Noël
Foucart
Director,
Sales and Marketing
World
Courier Belgium N.V.
6
A Hermesstraat
B-1930
Zaventem
Belgium
Telephone:
32/2/712-5080
Fax: 32/2/712-5089
E-mail: nfoucart@worldcourier.be
Latin America
Carlos Jankowski
Regional Director, Latin America
World
Courier Argentina S.A.
Avda. Corrientes 316 D, Piso 7
Buenos Aires, Argentina
Telephone:
54/1/4328-8300
Fax:
54/1/4328-5879
E-mail:
Asia
Pacific
Korhan
Yalcinyuva
Regional
Director, Asia Pacific
World
Courier (Australia) Pty. Ltd.
Unit
1, 8 Lord Street
Botany
N.S.W. 2019
Australia
Telephone:
61/2/8335 9100
Fax:
61/2/8335 9170
E-mail: kyalcinyuva@worldcourier.com.au