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Logistical Challenges for International Cold Chain Shipments

Cold chain experts agree you have to have people "in country" to help negotiate rules, regs and local customs

Many markets are emerging for clinical trials because the FDA requires "naïve patients," or places like the Ukraine are used to easily fill quotas, or even because the drug being tested might be sold into that country eventually.

The number-one emerging market is China, followed by Brazil, Russia and India.

But don't discount other countries like Korea, Viet Nam, Turkey, Venezuela, Pakistan and Romania.

Your successful international cold chain shipping program really depends on local people you can rely on. Typically, a first-time big problem or even numerous smaller excursions usually can be traced back to human error-and the loss of one knowledgeable "local" can be devastating.

Training, and retraining is key.

So whether you outsource to a CRO, or hire your own in-country person, you need "feet on the street" at the point of delivery to make your international cold chain shipments a success.

Particularly frustrating is the fact that many countries want to extract additional revenue from you thinking you have deep pockets.

Tests that you have already done and paid for in the U.S. may be ordered in that country, but are they really required?

A local contact who knows the rules and regs-and local culture and customs-is a must.

Brazil and Argentina were cited as good sites for clinical trials, but two countries that have set ridiculously high hurdles for investigational drugs.

They certainly don't make it any easier to bring in drugs in a timely manner. Worse, cooperation between countries in Latin America may be non-existent.

You may have an overage of shippers in country A and a shortage right next door in country B. But you may have to ship through the U.S. or the U.K. just to move a product a few hundred miles as the crow flies.

This is opposed to the EU where once you have drugs on the ground, going from country to country is relatively painless.

Information for the article above came from a round table discussion at the 10th Annual Cold Chain and Temperature Management Global Forum in Chicago, September 26, 2012.
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