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The Single Source of Truth
Sarbanes-oxley, 21cfr part 11, HIPAA, pharmaceutical CGMPS for the 21st Century: The industry has been hit in the past three years with a regulatory load unprecedented in its depth, breadth, and complexity. And because record-keeping, security of records, and auditability are at the core of what the federal government seems to be trying to accomplish, information technology is at the core of pharma's response. Across the industry, companies are scrambling to gain more complete control over their data.
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Changing Diabetes
Martin Soeters (pronounced soo't rs) has dedicated a quarter century—almost half his life—to the company at which he's now president of US operations. Novo Nordisk, where Soeters has worked since 1980—in various executive roles and locations, from The Netherlands (his homeland) to Belgium to France—is a leader in diabetes treatment, with the largest portfolio in the industry.
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Japanese Wedding
Just how traditional marriages join a couple together from a common
culture, Daiichi and Sankyo are merging based on a sense of having
come from the same place, and facing the same future. But the art
of integration lies in creating new ways of working that make the
marriage bigger than the sum of its parts. Officiating the marriage
is John Alexander, MD, head of pharma development for Daiichi
Sankyo.
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Scientific Expression
Back in December 2005, the New England Journal of Medicine (NEJM) issued an "Expression of Concern" over the VIGOR (Vioxx Gastrointestinal Outcomes Research) study published in 2000. The journal's editors stated that omissions regarding adverse cardiovascular events called the integrity of the study into question, and asked the VIGOR investigators to submit a correction.
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PharmExec's 2006 Forecast
Medicare Part D launches. $23 billion worth of patents expire. FDA wrestles with safety issues. Pharma prepares for unprecedented cost cutting and restructuring. 2006 promises to be banner year—if you like roller coasters.
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50 5 2005:
Five things you can do to prepare for compliance in all 50 states - starting today
Implementation of policies that respond to industry compliance standards poses a considerable burden for companies in terms of time and expense. Unless industry changes its response to state laws, the condition will worsen.
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