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October 11, 2012 | ISSUE NUMBER 272 VOL 8

Special Feature
Election 2012: The Drug Vote
President Obama's four years of real-world data has undermined initial investor confidence. Mitt Romney is challenging Obama's White House exclusivity with a marketing and promotional budget unmatched in the history of DTC. But it's unlikely that improvement against placebo will occur under either incoming administration. That said, Ben Comer highlights a few distinctions and similarities that are worth noting before heading into the polling dispensary on November 6th ...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

Regulatory
Meningitis Outbreak Spotlights Compounded Drug Confusion
The call for stiffer FDA regulation of compounded drugs has been reignited by a national fungal meningitis outbreak: Seven deaths have been linked to contaminated vials of steroid injectables from the New England Compunding Center (NECC). NECC has been cited by FDA and state regulators for a range of violations in recent years
...Read More

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2nd Annual Interactive Response Technologies for Clinical Trials
November 8-9, 2012 * Sonesta Hotel * Philadelphia, PA
Learn best practices in gaining insights into IVR/IWR system utilization in clinical trials and learn how companies are using clinical IRTs to increase efficiencies and decrease costs
Register by November 7, 2012 at www.cbinet.com/IRT and save $400 with priority code: FHZ888.

Video
Should Pharmacies Be Held to the Same FDA Standards?
While all of the details of the meningitis outbreak are not yet know, it is clear that the pharmacy industry has failed to adequately police its compounding practices ...Read More

Marketing
The Affordable Care Act and Pharma Marketing
With the Supreme Court's decision in June to uphold the Patient Protection and Affordable Care Act (ACA), life science companies gained access to 32 million potential new customers. While that's worth celebrating, the party may have ended before it began. For pharma companies to realize the benefits of new healthcare consumers, and to keep the ones they currently have, they'll have to make some substantial changes, which is never easy, writes Gregg DiPietro

...Read more

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2nd Global Transparency Reporting Congress—17-18 October, 2012 Amsterdam, Netherlands
Implement Business Processes to Manage and Report HCP Spend Data. Attend the premier Transparency Reporting event of the year and hear best practices for tracking and disclosing data, controlling spend on HCPs, implementing efficient systems and aligning goals across the company from EFPIA, Sanofi, Johnson & Johnson and more! Register by 16 October, 2012 at www.cbinet.com/transparency and save €300 with priority code: KDZ968.

Global
Richard Bergström: Europe's Medicine Man
The head of the European Federation of Pharmaceutical Industries and Associations (EFPIA) faces a Promethean challenge: selling the merits of costly science and innovation in an era of bristling competition, fiscal crisis, and declining demographics
...Read more

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The Growing Role of the Patient in Cancer Treatment Selection
Live Webcast: Wednesday, October 17, 2012 at 11:00 AM EDT
Register Free at www.pharmexec.com/growing

// Sanofi appointed Dr Paul Chew as Chief Medical Officer and Head of Global Medical Affairs. He succeeds Jean-Pierre Lehner, who retires December 31. // Amgen announced the appointment of ex-Johnson & Johnson Communications Leader Ray Jordan to the new position of Senior Vice President, Corporate Affairs. // The Research Partnership appointed Paul Dick, Vice President of Business Development, and Phil Rosenberg, Research Director, to its US team. The company also appointed Sarah Tax to its US office as a Research Executive.// Louise Tamblin rejoined Kantar Health (New York, NY) as Group Director. The company also promoted Graeme Jacombs to Managing Director of the Asia Pacific, Middle East and Africa Region.
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The Path to Agile Brand Management
TLive Webcast:Thursday, October 25, 2012 at 2:00 pm ET
Register Free at www.pharmexec.com/agile

October 17–18: 2nd Annual Global Transparency Reporting Conference
Amsterdam, The Netherlands


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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