Policy & Regulation: Page 22


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    Compliance Wrap Up

    Compliance Forum The pharmaceutical industry continues to face major obstacles in attaining patient persistency and compliance. During CBI’s two day conference, thought leaders addressed the topic of patient compliance from many different avenues and provided their insights on ways that key stake...

    By PharmaVoice Team • May 28, 2008
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    On the Calendar

    February 10,2003,Park Hyatt San Francisco — San Francisco European Regulatory Affairs: An InDepth Review of Registration Procedures in the European Union This Drug Information Association training course will cover the evolu tion of the registration systems available for approval of products sinc...

    By PharmaVoice Team • April 24, 2008
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    Trendline

    Commercialization, marketing and social media

    As the pharma industry stares down a historic patent cliff, macroeconomic headwinds and challenging R&D costs for increasingly complex medicines, nailing the launch of new medicines has become increasingly critical. 

    By PharmaVoice staff
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    PharmaTrax

    Survey Shows One Third of Americans USE ANTIBIOTICS INAPPROPRIATELY A survey conducted by Harris Interactive has revealed that one out of three Americans mistakenly believes antibiotics are effective in treating viruses such as cold and flu and takes these drugs to fight these viruses. The survey...

    By PharmaVoice Team • April 24, 2008
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    Talent Pool

    EXECUTIVE APPOINTMENTS AND PROMOTIONS IN THE HEALTHCARE INDUSTRY Pharma POOL John I. COOPER Former GlaxoSmithKline VP Brings Global Manufacturing and Operational Management Expertise to ICN ICN Pharmaceuticals Inc. has appointed John I. Cooper as executive VP of global manufacturing and supply. I...

    By PharmaVoice Team • April 22, 2008
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    PharmaCase

    What Pharma can Learn from Insurance e-Business SELLING HEALTHCARE INSURANCE ONLINE IS ONE OF THE MORE COMPLEX E-COMMERCE APPLICATIONS.HOW ONE INSURER, BLUE CROSS BLUE SHIELD OF FLORIDA, OVERCAME THE TECHNICAL AND CUSTOMER RELATIONSHIP CHALLENGES TO CREATE A PROFITABLE ONLINE SALES CHANNEL CAN S...

    By PharmaVoice Team • April 22, 2008
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    Opinions

    WHAT’S on your mind Is mentoring a lost art? For the past two years, January has been designated as National Mentoring Month (NMM). Led by the Harvard Mentoring Project and MENTOR/National Mentoring Partnership, NMM also was supported by President George W. Bush, the U.S. Congress, state governor...

    By PharmaVoice Team • April 22, 2008
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    Letter from the Editor

    THE FORUM FOR THE INDUSTRY EXECUTIVE Volume 3 . Number 4 PUBLISHER Lisa Banket EDITOR Taren Grom CREATIVE DIRECTOR Marah Walsh DIRECTOR OF SALES Darlene Kwiatkowski MANAGING EDITOR Denise Myshko CONTRIBUTING EDITORS Elisabeth Pena Kim Ribbink Alex Robinson Lynda Sears Copyright 2003 by PharmaLinx...

    By Taren Grom • April 22, 2008
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    The Shifting Relationship Between Pharmaceutical Companies and Suppliers

    The shifting relationship between pharmaceutical company and supplier: Are partnerships in peril? Fundamental aspects of the supplier/client relationship are changing. At the extreme these changes could threaten the very relationship; at the minimum these changes will require a modification in th...

    By PharmaVoice Team • April 21, 2008
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    PharmaCounsel

    Legal Counsel: COMPLYING WITH PDMA Avoiding FDA Fire Sample Accountability: Employing Compliance Measures COMPLIANCE WITH THE PRESCRIPTION DRUG MARKETING ACT (PDMA) HAS BECOME AN INCREASINGLY URGENT ISSUE FOR PHARMACEUTICAL SALESFORCES AND THEIR REPS. AS GOVERNMENTAND INDUSTRY MOVE TO HEIGHTEN E...

    By PharmaVoice Team • April 21, 2008
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    Letter from the Editor

    PharmaVOICE THE FORUM FOR THE INDUSTRY EXECUTIVE Volume 3 . Number 5 PUBLISHER Lisa Banket EDITOR Taren Grom CREATIVE DIRECTOR Marah Walsh DIRECTOR OF SALES Darlene Kwiatkowski MANAGING EDITOR Denise Myshko CONTRIBUTING EDITORS Elisabeth Pena Kim Ribbink Lynda Sears Copyright 2003 by PharmaLinx L...

    By Taren Grom • April 21, 2008
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    Overcoming Diversity Obstacles: A Clinical Imperative

    22 Aug u s t 20 03 PharmaVOICE HE HUMAN GENOME PROJECT, research into responses to medicine, even the results of several clinical trials indicate that race and ethnicity do have bearing on the safety and efficacy of pharmaceuti cals. Consequently, it is critical that pharmaceutical companies, CRO...

    By PharmaVoice Team • April 17, 2008
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    E-Media

    76 J u n e 20 03 PharmaVOICE EMEDIA NEW ELECTRONIC AND WEBBASED APPLICATIONS, SITES, AND TECHNOLOGIES Choice Media has expanded its health newscov erage through an agreement with Ivanhoe Broad cast News, a newsgathering organization covering medical information for television stations. The rela t...

    By PharmaVoice Team • April 16, 2008
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    PharmaCase

    Common to many nonprofits is the develop ment of national publiceducation initiatives or cam paigns to enhance awareness about particular health issues. Often,these campaigns are supported by educational grants from pharmaceutical compa nies. Partnerships with nonprofits are important to pharmace...

    By PharmaVoice Team • April 16, 2008
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    Opinions

    6 J un e 20 03 PharmaVOICE WHAT’S on your mind Breadth and depth I find that industry associations do an excellent job in providing networking, pro fessional continuing education, industry rela tions, and businessdevelopment resources. I can’t speak highly enough about the breadth and depth of op...

    By PharmaVoice Team • April 16, 2008
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    Drugs For Seniors Take Center Stage

    ever there was a political hot pota to, a Medicare drug benefit is it. For at least a dozen years now, there has been much debate — but little consensus — on how such a benefit for Medicare beneficiaries should be structured and financed. Senior cit izens, politicians, healthcare, and pharmaceu t...

    By Denise Myshko • April 16, 2008
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    25 Years of the Orphan Drug Act

    Synthetic drugs accounted for 62% of total orphan drug approvals, and synthetic polypep tides and hormones together accounted for 6%. Among biologics, growth hormones and growth factors together have the largest num ber of approvals at 8% of the total. Market approvals received for plasma product...

    By Cynthia Borda • March 27, 2008
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    Global Opportunities

    According to Ernst & Young, the sheer volume and growing economic muscle of consumers in emerging markets provide powerful investment incentives for multinational companies (MNCs). In particular, current and projected growth rates for pharmaceutical markets in the BRIC countries and Mexico ex...

    By Robin Robinson • March 2, 2008
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    User Fees: Devising a Shift in Policy

    BY DENISE MYSHKO New laws and regulations aimed at improving reviews of medical devices have been put in place. In September 2007, President George W. Bush signed a broadranging bill that expands the regulatory authority of the Food and Drug Administration. Combined with the legislation were seve...

    By Denise Myshko • March 2, 2008
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    Managing Investigator Initiated Trials

    Investigator initiated trials (IITs) can be a valuable part of a pharmaceutical or medical device manufacturer’s marketing claims arsenal, according to Rita Numerof, Ph.D., president, and Mark Morgan, M.S., senior business analyst, at Numerof & Associates Inc. The two contend that IITs are re...

    By PharmaVoice Team • Jan. 30, 2008
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    Gene Therapy Research Makes Progress

    With all the progress that has been made in genomics, targeting therapies to correct the defective genes responsible for disease seems quite realistic. But developing commercial gene therapies to treat diseases through modifying the expressions of an individual’s genes or correcting abnormal gene...

    By Denise Myshko • Jan. 29, 2008
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    UpFront

    THE PRICE IS RIGHT Drug Pricing Decisions More Critical Than Ever In aneraofmore competition from generics, expiring patent protection for many topselling drugs, and a slowdown in new drug discoveries, there is very little margin for error in drug pricing decisions. Kalorama Information’s recent ...

    By PharmaVoice Team • Jan. 29, 2008
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    Letter from the Editor

    Wh o w o u l d h a v e thought that in 10 short years, we would have gone from Dolly to Elsie? In February 1997, scientists in Scotland announced the birth of the world’s first successfully cloned mammal, Dolly the sheep. Dolly, which was created at the Roslin Institute in Edinburgh, was actually...

    By Taren Grom • Jan. 29, 2008
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    Talent Pool

    Executive Appointments and Promotions Pharma POOL Dr. Corey Goodman Dr. Martin Mackay Dr. Briggs Morrison Pfizer Announces Executive Changes Pfizer has launched an independent, stand-alone biotherapeutics and bioinnovation center under the direction of scientist and entrepreneur Corey Goodman, Ph...

    By PharmaVoice Team • Jan. 2, 2008
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    Last Word

    Internationally renowned vaccines, immunology, and virology expert Paul A. Offit, M.D., has dedicated his career to discovering vaccines to prevent infectious diseases, and is the co-inventor of the rotavirus vaccine, RotaTeq, developed by Merck. A pediatrician, author, and scientific researcher,...

    By PharmaVoice Team • Jan. 2, 2008
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    E-Media

    New Electronic and Web-based Applications, Sites, and Technologies Thomson Scientific Offers Data Platform for Researchers Thomson Scientific has released BONDplus, an integrated, Web-based data platform designed to deliver real-time, comprehensive public and proprietary biological sequence, inte...

    By PharmaVoice Team • Jan. 2, 2008