In today’s environment of increased regulatory scrutiny, the pharmaceutical industry demands the very highest quality standards in order to meet all regulatory and ethical requirements.
Although compliance is largely assured during production, at the investigator sites and inside the laboratory, the fact remains that most clinical products travel thousands of miles over extended periods of time and diverse temperature conditions before arriving at individual research sites. How, then, is compliance assured throughout transit at these “non-scientific” locations and while in the hands of others?
In this video, Dr. Rüdiger Lomb, World Courier’s Global Director, Quality & Technical Compliance, discusses the specific guidelines that World Courier adheres to and the Quality Management systems it has implemented to deliver system-wide regulatory compliance to the pharmaceutical industry. He also outlines the many qualities that distinguish World Courier from its competitors and allow it to function as a trustworthy link within the pharmaceutical supply chain − especially crucial for studies being conducted in today’s challenging emerging markets.
A licensed pharmacist with a Ph.D. in pharmaceutical biochemistry, Dr. Rüdiger Lomb was formerly Group Head and Director of the Global Logistics Clinical Supplies Division for Bayer Schering Pharma AG (Germany) where he was responsible for the auditing and qualification of drug storage depots and transportation service providers.
Getting a clinical trial drug into China is a complex business. Any discrepancies in paperwork or the physical shipment can lead to delays at customs or China Inspection & Quarantine. World Courier shares its experience for successful shipping.
Down at the base of Africa is a country with amazing heritage, unique geography, and challenging patient populations. See why clinical trials happen in South Africa here