| October 18, 2012 | ISSUE NUMBER 273 VOL 8 |
Regulatory
Whistleblower Case Highlights FDA Confidentiality Issues
The news earlier this year that FDA scientists have been suspected of leaking secret information to the media brings serious Agency confidentiality issues to the fore ...Read more
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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.
Contact Email:ask@sciformix.com |
Disease Focus
Combo Drugs and Adaptive Trial Design Needed in Alzheimer's
FDA's head of neurology products told industry execs at the Prix Galien forum that the agency is open to alternative clinical trial designs in Alzheimer's, and would like to see more combination products in clinical testing
...Read More
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The Path to Agile Brand Management
Live Webcast:Thursday, October 25, 2012 at 2:00 pm ET
Register Free at  www.pharmexec.com/agile |
Emerging Markets: Specialty Drugs
Diabetes Drug Launch 2012: Tip-tops and Promo-flops
With Halloween candy flooding the shelves in pharmacies across the nation, it's only appropriate that we turn the conversation toward an ever-growing drug market and therapeutic area: diabetes ...Read More
Healthcare
Doctors Stand Against Pricey Drugs: A Warning to Pharma?
What does the decision of a trio of physicians at New York's Memorial Sloan Kettering Cancer Center to remove an expensive new cancer treatment from the hospital formulary mean for the drug industry?
...Read more
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Measuring the impact of e-prescribing on practitioner behavior and promotional effectiveness
Live Webcast: Thursday, October 25, 2012 at 11:00am EDT
Register Free at  www.pharmexec.com/eprescribing |
Global
Lundbeck: Bidding for the Stars and Stripes
Pharm Exec looks at how a European mid-tier player — Denmark's H. Lundbeck — is counting on the momentum of the big US market to vault it to global leadership in treatments that unlock the hard science of the human brain
...Read more
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 // Irish Prime Minster Enda Kenny TD officially opened the new US headquarters of Irish-owned Zenith Technologies (Zentek Automation US, Inc.) in Bluebell, Montgomery County, PA. // Harren Jhoti, PhD, President and Director of Astex Pharmaceuticals Inc. (Dublin, CA), was appointed to the BioIndustry Association (BIA) Board of Directors. // Global CRO Chiltern International (London, UK) named Dr Jim Esinhart as its next CEO, effective November 1, 2012. |
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Concerns have recently been raised about the safety of confidential data at FDA. Do you think regulators are doing enough to protect it?
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