Quality & Compliance

1 November 2011

The Regulatory Professional as Boundary Spanner

By Ira Asherman

Today’s regulatory professionals find themselves in an ever more complicated and challenging environment. Their core responsibility is to ensure their firm’s compounds move through the approval and labeling process as rapidly as possible.

The pressure to achieve this goal, among others, is constant and unrelenting, and the regulatory professional plays a central role in that process. He or she is the company’s representative in dealing with the governing agency as well as the person who translates the agency’s requirements and concerns back to his or her co-workers.

Everyone is concerned with how effectively the regulatory professional interacts with the agency. It is a process that everyone is watching and on which everyone has an opinion. Like it or not, the regulatory professional has a very critical and demanding audience.

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1 November 2011

Advent of Electronic Labeling

By Stefan Menzl, PhD, and Sibylle Scholtz, PhD

Today, mobile phones and mobile Internet access are widely used around the world. Information is available at all times and is just a “click” away. 

But instructions for use (IFU) for most medical devices still must be printed on paper and included with every product. By most standards, this is an anachronistic way of informing people.

Will we deal forever with tons of IFUs in dozens of languages printed on precious paper? Or, will there be soon an alternative?

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