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May 3, 2012 | ISSUE NUMBER 249 VOL 8

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Legal
Biosimilars Under Threat?
While the FDA continues to develop its guidance for US biosimilars, their basic legal underpinnings may be under threat, as the Supreme Court debates the healthcare law. D'vorah Graeser reports ...Read more

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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

Healthcare
Less is More: HSS's Austerity Care
As the US Department of Health and Human Services (HHS) circles      around the elements of healthcare that will actually be included in our            new “Essential Health Benefits”, one aspect of the EHB offering has caused a tremendous stir among dozens of health groups, writes Tom Norton ...Read More

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Adam Smith Conferences' Russian Pharmaceutical Forum (22-24 May, St. Petersburg, Russia) - the biggest industry event of the year, with over 500 senior executives representing all the leading international and local pharmaceutical companies, distributors, retail chains, gathering to attend to discuss all the burning questions of the day, to compare experiences and share ideas for the future. Get involved – REGISTER TO ATTEND at https://www.adamsmithconferences.com/hr21pebw

Marketing
Heady Ideas for Digital Health Marketing
If you really want to know what’s on a patient’s mind, it’s best to skip the small talk and go straight to the brain waves, as demonstrated by Neuro Insight CEO Pranav Yadav in the lead-off presentation this week at Chandler Chicco’s Pioneers in Digital Health conference. Ben Comer reports ...Read More

Global
Looking for Success in Emerging Markets? What's Your Corporate Value Proposition?
Pharma companies entering the emerging markets are under pressure to offer a convincing Corporate Value Proposition (CVP), writes Nigel Thompson. But what is a good CVP?
...Read more

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CBI's 4th Annual Summit on Clinical Trial Investigator Portals
May 15-16, 2012 * Philadelphia, PA
Provide High-Quality Data to Study Teams for Real-Time Reporting Learn best practices in utilizing clinical portals for efficient study start-up reducing trial costs workload of clinical investigator sites with Merck & Co., Inc., Quintiles, GlaxoSmithKline, and more!!! Register by May 15, 2012 at http://www.cbinet.com/portals and save $300 with priority code: GMA284.

// Novartis promoted Brian McNamara from President Novartis OTC Americas to head of its entire over-the-counter division. // Evoke Interaction (New York, NY) hired Mike Dennelly as New York Managing Director. // Dr Dirk Ehle has been appointed Head of the Animal Health Division of Bayer. // Deepak Khanna, Senior Vice President and MSD UK managing director, has been appointed as President of the UK Association of the British Pharmaceutical Industry (ABPI) after his recent election.
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Break Through the Barriers to Better Oncology Targeting with Medical Claims Data
Live Webcast: Tuesday, June 5, 2012 at 1:00 PM EDT
Register free at http://www.pharmexec.com/barriers

May 7–8: Bio/Pharma Forum on Regulatory Policy
Washington, DC


June 19–20: 3rd Annual Life Sciences Forum on Social Media Regulations and Compliance
Alexandria, VA


Augusts 14–16: 6th Annual Forum on Sunshine and Aggregate Spend
Washington, DC

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Utilization of Rasch Measurement Models for Assessing Validity: A Mixed Methods Approach
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