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May 31, 2012 | ISSUE NUMBER 253 VOL 8
Legal House Under Pressure to Act on User Fee Legislation
All it took was the prospect of collecting some $6.4 billion in user fees to fund the Food and Drug Administration to halt the partisan bickering and bring Senate Democrats and Republicans together to quickly pass the FDA Safety and Innovation Act (FDASIA). Leaders of the House indicated they would consider its version of the legislation ASAP, in order to finish work on the complex bill by the end of June...Read more
Advertisement Establishing Case Quality Metrics - defining and using quality metrics for adverse event case processing.
Measurement of case quality in pharmacovigilance is a relatively new development. Until pharmaceutical companies began outsourcing their case processing operations, the only measure of effectiveness of their internal operations was compliance with regulatory reporting timelines. Now that these operations are performed by vendors, over the last two years vendor management organizations within pharmaceutical companies and Health Authorities have come up with a way to measure the "quality" of Adverse Event (AE) cases. This paper captures our experience and learning in defining and using case quality metrics while working with large and small pharmaceutical companies. http://www.sciformix.com/Establishing.php
Global Too Much Sauce Hollandaise? Reflector on Pharma and France's New Socialist President
So it happened. A leading European country has gone against the predominant political grain, and elected a socialist head of state. France is now ruled by François Hollande, a mild-mannered but avowedly drug-industry-skeptical president. So is the sky about to fall? Pharm Exec's EU correspondent Reflector reports ...Read More
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Data Optimize the Information Explosion
In pharma the options for using data have proliferated to the point of becoming overwhelming. So, what are the opportunities presented by this information explosion, asks Don Ragas ...Read More
Recruitment and Retention Don't Look Down On Your Middle!
That middle managers are feeling underinvested in and say they lack the skills that are crucial to making their level of the business operate successfully is a real threat to the pharma sector, writes Hamish Scott ...Read more
Advertisement Creating Value in Contract Management Data Growth
Live Webcast: Thursday, June 7, 2012 from 1:00 PM - 2:00 PM EDT
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// AstraZenca's Executive Director and Chief Financial Officer Simon Lowth takes over as the company's interim Chief Executive Officer from June 1, when current CEO David Brennan retires. // Dr Matthew Wikler, a former Deputy Director of the US Food and Drug Administration (FDA), was appointed Chief Development Officer of Rib-X Pharmaceuticals (New Haven, CT). // Michael Holston is to join Merck & Co as its new Chief Ethics and Compliance Officer from June 25, 2012. He will replace Richard Bowles, who is retiring. // Laura L. Parks, Ph.D., was appointed President and Business Unit Director of finished dosage business at DSM Pharmaceutical Products (Parsippany, NJ).
Advertisement The Basics of the Sunshine Act and the Implications for Your Business
Live Webcast: Tuesday, June 12, 2012 at 2:00PM EDT
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Advertisement Optimizing R&D Spending at Hospira
Live Webcast: Wednesday, June 20, 2012 at 01:00 PM EDT
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