spacer
home > ict > autumn 2016 > changing face
PUBLICATIONS
International Clinical Trials

Changing Face

The investigational study of pharmaceutical and biotechnology products is rapidly becoming a global endeavour. While the development of drugs has necessitated material supply such as active pharmaceutical ingredients, and with drug manufacture gradually moving from traditional developed countries like the US or European member states to emerging ones such as China and India, we are now witness to a geographic shift for the implementation of these trials.

International Range


In past years, a multi-country study might have involved only the US and developed European countries. This would require multi-language labelling and contending with the multitude of country-specific regulatory requirements, but would be limited to a handful of countries with advanced healthcare infrastructures to support the needs of a trial.

In today’s market, investigational studies are spreading to many emerging markets – including Russia, Ukraine, Eastern Bloc countries, Latin American countries such as Brazil and Argentina, as well as Central America. There is also a rise in conducting trials in the Asia-Pacific region, with significant population growth and rapidly developing healthcare infrastructure in dense urban areas.

It is, therefore, appealing to carry out investigational drug studies in the Asia-Pacific region, but this does come with risks and challenges depending on the location of the trial sites and the laws governing the country where the study is to be administered. For example, the regulatory requirements in Japan can vary significantly to those in regional neighbours like China, Malaysia, the Philippines, Taiwan, Singapore, South Korea and others. Every country needs to be evaluated independently for its attractiveness and its relative regulatory and logistical risk, as each is distinctly unique.

Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

 You must be a member of the site to make a comment.
spacer
Rich Nelson is the Distribution Services Manager for PCI’s Clinical Services group, working with clients to provide seamless global distribution of their investigational products. Rich joined PCI in 2012 after seven years with Fisher Clinical Services, having supported both global distribution of investigational products as well as interactive voice response system solutions. He is certified in Lean Six Sigma/continuous improvement, and is a graduate of Monmouth University in West Long Branch, New Jersey.
spacer
Rich Nelson
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

Fresenius Kabi modernises production facility in France

Fresenius Kabi is investing about €35 million to modernise the company’s production facility in Louviers, France. Two sterilisation units and two production lines for Freeflex® infusion bags will be housed in a 3,300-square-meter (35,500-square-foot) building being constructed on the site and will replace the existing production facilities. In this way, the company will continue to ensure the availability of these important products into the future. The modernisation is scheduled for completion before the end of 2023. Fresenius Kabi employs some 370 people at the Louviers plant and has a total of about 1,500 employees in France.
More info >>

White Papers

Customising the Cold Chain

World Courier

Of all the statistics emerging around the global pharmaceutical industry this year, two big numbers capture the attention of both manufacturers and their logistics partners: $248 billion, the amount the “BRIC” nations (Brazil, Russia, India and China) are poised to account for in pharmaceutical sales for by 2016; and $8 billion, the amount global pharma will spend on cold chain logistics in 2014. Why are these two numbers so noteworthy? They demonstrate that as R&D goes, so goes logistics. As products evolve to meet demands for more targeted therapies, demand for more targeted logistics solutions grows as well. And that means a need for customization for everything from clinical trial samples to finished product.
More info >>

 

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement