OSLO, Norway, July 25, 2007—World Courier’s 15th International Seminar on Global Clinical Trial Logistics and Cold Chain Management, scheduled for November 16, 2007 at the Radisson SAS Hotel in Copenhagen (Denmark), will address some of the most cutting-edge concerns of today’s pharmaceutical and life science professionals: how to maintain perfect control, perfect quality and perfect audit capabilities while conducting clinical trials in new and emerging markets with new regulations and new temperature requirements.
“Copenhagen was chosen as the site for this year’s seminar because of its central location within Europe and its close proximity to Moscow where we recently opened our seventh international investigational drug storage depot,” says Wayne Heyland, President and CEO of World Courier Group.
“Eastern Europe’s growing popularity as a site for clinical trials combined with the region’s sometimes unique climate and logistical challenges makes this seminar particularly timely for members of the European scientific community who are interested in successfully managing research projects in this emerging area.“
For this prestigious seminar, World Courier will bring together a distinguished panel of speakers from top companies to share their experiences, provide insight into the latest developments in clinical trial logistics and cold chain management, and to explore the challenges of validating and qualifying clinical samples, investigational drugs and related materials during transport.
The realities of managing clinical trials in Russia and Eastern Europe will be discussed, with panelists offering guidance on product distribution and storage in these locations. The latest regulatory developments in international validation will also be examined as will impending IATA regulations for the transport of clinical trial samples/supplies and new EC quality standards for Good Manufacturing Practice (GMP).
This seminar offers an exceptional opportunity for members across the pharmaceutical industry – medical directors, project managers, investigators, study coordinators, logistics managers, CRAs and lab personnel who bear responsibility for the distribution of clinical supplies/samples or for the safety of staff – to hear from regulators, sponsors, suppliers and users alike. Delegates will also enjoy an engaging environment in which to network with industry colleagues.
Reservations for this important one-day event can be made by contacting any World Courier office, or by visiting the corporate website at www.worldcourier.com.
About World Courier
World Courier is the global leader in the transport of clinical samples, investigational drugs and clinical trial supplies for the pharmaceutical industry, with proven experience in the handling of time-critical and temperature-controlled consignments. Founded in 1969, World Courier currently maintains an international network of more than 140 company-owned offices in 50 countries worldwide. World Courier is the only courier company to handle each and every shipment on a customized and individual basis. As part of its comprehensive biopharm and clinical trial service, World Courier will host its 15thinternational seminar in Copenhagen to increase awareness and knowledge of the regulatory and procedural issues involved in global clinical trials.
Kristin Haraldsen, Sales & Marketing Executive
Direct: +47 63 94 62 30
World Courier (Norway) AS
Tlf: +47 63 94 62 00
Fax: +47 63 94 62 01
APPENDIX 1 – BACKGROUND INFORMATION
Topics concerning the following regulatory and logistical directives will be addressed by seminar panelists:
changes in IATA regulations
EC regulations for GMP
requirements for clinical trial material storage/distribution in emerging countries
the evolution of clinical trials in Russia and other emerging markets
clinical trial supply in emerging countries
clinical trials and the hospital pharmacist
cold chain management
validation of temperature-controlled distribution
effective air transport for cold chain distribution and the validation process
Associate Director for Distribution Services
Manager, Special Cargo Standards
Vice President, Business Development
Almac Group Ltd.
Manager Global Logistics
Novo Nordisk A/S
Quality & Environment Manager
SAS Cargo Group A/S
Dr. Mikhail Samsonov
Executive Director, Regional Clinical Operations International
Bristol-Myers Squibb International Corporation
Senior Manager Validation, PS PH Supply Chain Management
Bayer Schering Pharma AG
Clinical Director of Pharmacy
University Hospital of North Staffordshire, NHS Trust
Michael T. Sweeney
Director, Development & Compliance
World Courier, Inc. (USA)
Unit Manager, Divisional Quality, Systems and Standards
Medicines and Healthcare Products Regulatory Agency (MHRA)