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October 25, 2012 | ISSUE NUMBER 274 VOL 8

Election 2012
Obamacare after Nov 6th: Trouble for Pharma?
No doubt the November 6th election is going to be close. So close, in fact, it's possible that no substantial political change will occur in Washington as a result.That said, for the US pharmaceutical industry this is not going to be an election without consequence. Tom Norton reports ...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

Global
Europe: Health Commissioner's Sudden Exit Spotlights Regulation Crisis
The abrupt departure of EC Health Commissioner John Dalli in highly controversial circumstances tops an extremely difficult year for the European Medicines Agency (EMA), writes Reflector ...Read More

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Adopting a Pragmatic Approach to Compliance: Proactively Managing Aggregate Spend Data for Disclosure and Transparency Reporting
Live Webcast: Tuesday, October 30, 2012 from 1:00 - 2:00 pm EDT
Register Free at www.pharmexec.com/spenddata

Special Report
Ethics in Drug Innovation: The First Hurdle is Trust
Ethics is a matter of trust, which in the regulatory space requires transparency and openness among all stakeholders. This was the consensus of FDA Commissioner Margaret Hamburg and EMA Executive Director Guido Rasi, both of whom shared the podium at a plenary lunch panel on "Ethics of Innovation" at last week's Prix Galien Forum in New York
...Read more

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Brand: Going Beyond Single-Mindedness
Live Webcast: Thursday, November 8, 2012 from 2:00 PM - 3:00 PM EST
Register Free at www.pharmexec.com/single

Global
Spanish Generics Industry to Government: "Leave Branded Pharma Alone"
Just days before the reports that R&D investment in Spanish pharma had fallen to below EUR1 billion ($1.3 billion) in 2011 for the first time since 2007, the country's generic manufacturers association, AESEG, offered some unexpected support for the branded 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

Digital Pharma
Locating the Human Ghost in the Digital Machine
Featured panelists at ExL's annual Digital Pharma East conference last week included practicing physicians, vocal ePatients, social media gurus and digital marketing consultants with plenty of hours logged in Big Pharma boardrooms, writes Clark Herman
...Read more

// AP Pharma (Redwood City, CA) appointed Robert Rosen as Senior Vice President and Chief Commercial Officer. // Amgen announced the appointment of Cynthia Patton to Senior Vice President and Chief Compliance Officer. // Osmotica Pharmaceutical Corp. (Wilmington, NC) named Dr Praveen Tyle as Executive Vice President and Chief Science Officer. He also serves as Managing Director of the company’s Marietta, GA, site.

November 15: Medical Devices: Future Trends and Technologies in Combination Products
Waltham, MA


November 28–29: 3rd Annual West Coast Compliance Congress San
Francisco, CA


December 10–12: Social Media, Mobile & Gaming for Pharma
New York, NY


December 11–12: 2012 Life Sciences CRM Forum
Philadelphia, PA.


January 24–25, 2013: 3rd Developing CAPAs in the GCP Environment Conference
Arlington, VA.


January 24–25, 2013: 5th Risk Evaluation and Mitigation Strategies Summit
Arlington, VA.


 
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