Final Word - BioPharm International

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Final Word

Validation Failure is Not an Option. Should it be?

June 1, 2008

The industry needs to open up to validation failures.

Managing the Global Supply Chain

May 1, 2008

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.

Pharmaceutical Quality Success: It's All About Management

April 1, 2008

Engaging executive leadership in the quality process is the key to compliance success.

Can the FDA Live up to its Promise of a Risk-Based Approach to Compliance?

March 1, 2008

The expanding globalization of the industry poses a challenge for international enforcement.

The Role of Analytical Science in the Debate over Biosimilars

February 1, 2008

Both innovator and generics companies are using analytics to support comparability arguments.

Evaluating China's Intellectual Property Situation

January 1, 2008

The Chinese government is making consistent efforts to strengthen IP protection.

Has the Era of Blockbuster Drugs Come to an End?

December 1, 2007

Eighty drugs will lose patent protection between 2007 and 2011.

How to Develop a Pool of Talented People

November 1, 2007

CMOs must take a proactive approach to ensure the availability of local talent

Back to the Future

October 1, 2007

One company even connected hollow fiber cell culture chambers to living cows.

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