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International Clinical Trials

Surveying the Scene

Herbert Hoover once said: “About the time we can make the ends meet, somebody moves the ends”. The key is to have an idea of when the ends may be subject to movement. In the life sciences industry, understanding the changes afoot in the regulatory arena are key to ensuring that regulatory strategies can be adjusted appropriately with the hope of not adversely affecting the development timeline or costs.

The results of a recent survey, conducted by Thomson Reuters Market Research, provide insight into the emerging and future trends of regulatory product management needs for the life science market. The survey concentrated on four key areas: technology usage trends, including submission publishing, registration management and other technologies; document management system usage; regulatory operations outsourcing trends; and regulatory trends, including use or future use of the electronic common technical document (eCTD).

The survey was a quantitative web-based survey conducted in May 2008. One hundred and thirty-seven regulatory affairs individuals from life science companies across the globe responded to the survey, with over two-thirds (68%) from the...

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Sarah Powell is the Executive Director of Regulatory Strategies for Liquent, part of the Scientific business unit of Thomson Reuters. Sarah has 22 years of experience in the pharmaceutical and related regulated industries. For the last eight years she has worked on a variety of projects related to implementation of regulatory solutions, and has contributed to defining product strategies for industry leading software solutions. Whilst in industry, Sarah performed a variety of roles within the clinical, quality, regulatory affairs and regulatory operations groups. She has extensive experience with the FDA Guidance for Electronic Submissions, including recently established requirements for electronic submission of labelling information.
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