Recent events have highlighted the need for action with regards to how we handle materials from abroad.
May 1, 2008
By:
Paula J. Shadle, PhD
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Recent problems with food and pharmaceutical ingredients sourced from China highlight a major disadvantage of our complex international supply chains for food and drug ingredients. A global supply chain offers more opportunities for accidental contamination as well as intentional adulteration and counterfeiting. Sticking to minimal requirements may not be enough.
Apr 1, 2008
By:
Marta Jimenez-Aquino, David W. Husman, PhD, Thomas Feyerabend, Jr.
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Engaging executive leadership in the quality process is the key to compliance success.
Mar 1, 2008
By:
Warren Perry
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The expanding globalization of the industry poses a challenge for international enforcement.
Both innovator and generics companies are using analytics to support comparability arguments.
Feb 1, 2008
By:
Jeffrey R. Mazzeo
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Both innovator and generics companies are using analytics to support comparability arguments.
Self-awareness of IP protection among Chinese pharmaceutical companies is increasing
Jan 1, 2008
By:
Jim J. Zhang
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The Chinese government is making consistent efforts to strengthen IP protection.
Personalized medicines could become more popular than top earning drugs that face patent expiry
Dec 1, 2007
By:
Nafees Malik
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Eighty drugs will lose patent protection between 2007 and 2011.
CMOs must take a proactive approach to ensure the availability of local talent
Nov 1, 2007
By:
John W. Dobiecki
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CMOs must take a proactive approach to ensure the availability of local talent
Today's innovators are breaking new ground, just as we did three decades ago. This time, the process is accelerated, as scientists learn from the past.
Oct 1, 2007
By:
William R. Tolbert
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One company even connected hollow fiber cell culture chambers to living cows.
As the sophistication of products continues to grow, so do the risks associated with choosing the right partner
Jun 1, 2007
By:
Bikash Chatterjee
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Outsourcing has been a cornerstone of our industry for decades.
