Policy & Regulation: Page 19

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    E-Media

    New Electronic and Web-based Applications, Sites, and Technologies Featured Briefs: Inclinical, Terrosa Offer Collaborative CTMS Subscription Services Pharsight Offers PK Data Management Solution Compass Healthcare Leverages Social Media in Community Website IMS Health Speeds Access to Promotiona...

    By PharmaVoice Team • Sept. 28, 2009
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    What's New

    New Healthcare-related Products, Services, and Companies Featured Briefs: FDA Anticounterfeiting Draft Guidance Focuses on Chemical Identifiers inVentiv Renames Professional Development Business PCE Partners with ACU on Continuing Education for NPs, PAs Gullapalli Launches Patient-Centered CME Of...

    By PharmaVoice Team • Sept. 28, 2009
  • biotech market Explore the Trendline➔
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    Trendline

    Emerging biotech

    After years of financial turmoil, the biotech market is turning the page. Strong fundamentals, including solid clinical data, are key for biotechs hoping to capitalize on the improving conditions.  

    By PharmaVoice staff
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    UpFront

    Milestones 15th Anniversary CenterWatch, a provider of industry news, data analysis, and proprietary market research for clinical trials professionals and patients, recently celebrated its 15th anniversary. CenterWatch, which was founded in 1994, was acquired by Jobson Medical Information in 2008...

    By PharmaVoice Team • Sept. 28, 2009
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    Letter from the Editor

    Publisher Lisa Banket Editor Taren Grom Creative Director Marah Walsh Managing EDitor Denise Myshko Senior EDitor Robin Robinson features EDitor Kim Ribbink Contributing Editor Carolyn Gretton design associate Ariel Medel national account manager Cathy Tracy CIRCULATION Assistant Kathy Deiuliis C...

    By Taren Grom • Sept. 28, 2009
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    Letter from the Editor

    A Cautionary Tale Commissioner of Food and Drugs Margaret A. Hamburg, M.D., who was confirmed May 18, 2009, by a unanimous Senate voice vote, recently outlined her commitment “to prevent harm to the American people" through swift, aggressive, and effective enforcement of FDA laws and regulations....

    By Taren Grom • Aug. 20, 2009
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    Who's on the List by Section

    The Commanders & Chiefs 12 Ahsan Awan Ross Bjella Laurie Cooke, R.Ph. John Farinacci Tuan Ha-Ngoc Fred Hassan Thomas Hughes, Ph.D. Greg Johnson Rick Keefer Kyle Kennedy William Maichle John Maraganore, Ph.D. Francois Nader, M.D. Nader Naeymi-Rad Angus Russell Laurent Schockmel, DVM Jeffrey St...

    By PharmaVoice Team • July 30, 2009
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    The Reading List

    NON-FICTION Memo to the President: How We Can Restore America’s Reputation and Leadership • Madeleine Albright Making it all Work: Winning at the Game of Work and the Business of Life • David Allen Who Goes First?: The Story of Self-Experimentation in Medicine • Lawrence K. Altman It’s Not About ...

    By PharmaVoice Team • July 30, 2009
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    Manufacturer Windfall Rebates: Change on the Horizon

    The transfer of drug coverage for the dual eligible beneficiaries from Medicaid to Medicare Part D has come under scrutiny by Congress for alleged profit windfalls for manufacturers. The implications of the windfall issue for the pharmaceutical industry are vast. Manufacturers with a large Medica...

    By Matthew Warburton and Carleen Kelly • May 25, 2009
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    Predicting the Future The Business Case for Forecasting

    By Kim Ribbink Risk is an inherent part of the pharmaceutical business — risk of failure in clinical trials, risk that a product won’t achieve regulatory approval, risk that a product underperforms in the market, and risk of withdrawal after adverse reactions and the costly lawsuits that can foll...

    By PharmaVoice Team • March 25, 2009
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    What's New

    New healthcare-related products, services, and companies TGaS Advisors Offers Regulatory Service TGaS Advisors has launched the next generation of its Commercial Compliance Benchmark (CCB) to help companies navigate in a demanding and evolving regulatory environment. The new benchmark expands and...

    By PharmaVoice Team • March 25, 2009
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    Defining GLOBAL

    BY DENISE MYSHKO AND ROBIN ROBINSON KARLA ANDERSON Managing Director, Life Sciences BearingPoint Global is a perspective of looking at the business in its totality, not just at a given market or a given country or a given set of rules and regulations, but at the business as a whole. It’s always c...

    By Denise Myshko and Robin Robinson • March 1, 2009
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    Global Thought leaders

    Karla Anderson, Managing Director, Life Sciences, BearingPoint Inc. — A provider of management and technology consulting services. For more information, visit bearingpoint.com. Leone Atkinson, M.D., Senior Director of Clinical Development, PTC Therapeutics Inc. — A biopharmaceutical company focus...

    By PharmaVoice Team • Feb. 27, 2009
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    GLOBAL Safety Issues

    BY DENISE MYSHKO The European Commission has proposed a series of efforts, commonly referred to as the Pharmaceutical Package, which contains three important initiatives: a proposal for a directive on how to modernize pharmacovigilance; a proposal to address counterfeit medicines; and a directive...

    By Denise Myshko • Feb. 27, 2009
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    The GLOBAL Regulatory Environment

    By Denise Myshko The concerns of regulators around the globe lean toward the safety and the cost-effectiveness of prescription drugs. Cost-containment has and will continue to be the buzzword as governments around the world struggle with slowing economies and rising healthcare costs. In fact, som...

    By Denise Myshko • Feb. 27, 2009
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    Technology Key for GLOBAL Development

    BY DENISE MYSHKO Experts say technology has the potential to help pharmaceutical sponsors address communication challenges, manage data effectively across geographic regions, and ultimately speed processes. “Communications technology is core to global development," says Brad Thompson, Ph.D., chai...

    By Denise Myshko • Feb. 27, 2009
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    Last Word

    Ms. Stokes says companies need a safety plan, one that includes efficacy and safety data as well as risk-benefit information, before a drug reaches the market. Drug Safety Alliance’s Cathy Stokes defines safety expectations As CEO and President of Drug Safety Alliance Inc., Cathy Stokes is focusi...

    By PharmaVoice Team • Feb. 26, 2009
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    Upfront

    Milestones kinetix turns 10 Kinetix, a specialized healthcare consulting firm that uses exclusive, proprietary communication channels to build and implement live and online marketing programs, is celebrating its 10th anniversary. Over the last 10 years, Kinetix has developed strategies to communi...

    By PharmaVoice Team • Feb. 26, 2009
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    Talent Pool

    TALENT POOL EXECUTIVE APPOINTMENTS AND PROMOTIONS IN THE HEALTHCARE INDUSTRY Pharma POOL Lamberto ANDREOTTI Dr. Andrew G. BODNAR Donald J. HAYDEN Dr. James B. D. PALMER Thomas J. PICKARD David L. ZABOR Bristol-Myers Squibb Announces New Senior Leadership Team — Appoints Former GlaxoSmithKline V...

    By PharmaVoice Team • Feb. 23, 2009
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    What's on your mind: Opinions

    OPINIONS Information standards In the November/December issue of PharmaVOICE, we asked if the Food and Drug Administration should consider relaxing its standards for press releases about drug approvals, which currently are almost always considered a promotion. The regulatory agency issued a call ...

    By PharmaVoice Team • Feb. 22, 2009
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    Medical Privacy: At What Cost

    By Denise Myshko WHILE QUESTIONS REMAIN ABOUT WHAT THIS ULTIMATELY WILL MEAN FOR CLINICAL RESEARCH AND THE INDUSTRY’S ACCESS TO DATA,ONE THING IS CERTAIN: AN EXTRA LAYER OF ADMINISTRATION HAS BEEN ADDED FOR EVERYONE. Privacy has become a political hot potato in the healthcare industry as advances...

    By Denise Myshko • Feb. 17, 2009
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    Carl Feldbaum: Beyond Imagination

    CARL FELDBAUM BIOTECHNOLOGY INDUSTRY ORGANIZATION BIO HELP WANTED: President of a new biotech industry association, no industry experience necessary. Position has enormous promise for personal and professional growth. “In 1992, I didn’t know a single person in the industry,” Carl Feldbaum says. “...

    By PharmaVoice Team • Feb. 16, 2009
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    Independent Agencies

    To paraphrase Mark Twain, reports of their death have been greatly exaggerated. Independent agencies are a viable strategic and creative option for many healthcare clients. True, the number of independent agencies has dwindled over the past few years; many making the strategic decision to join a ...

    By PharmaVoice Team • Feb. 16, 2009
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    Global Harmony Comes to Drug Development

    That document — called the common technical document or CTD — is now being accepted by regulatory agencies in the United States, Europe, and Japan as part of a transition phase. Consensus was reached by the international pharmaceutical community in May of this year. This document will eventually ...

    By Denise Myshko • Feb. 16, 2009
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    E-Media

    NEW ELECTRONIC AND WEBBASED APPLICATIONS, SITES, AND TECHNOLOGIES RapidTrials.com, launched by PCRS Inc., is the first Webbased platform to provide realtime bench mark metrics on trial progress for research centers. The pro gram helps drive revenue, study programs, and marketing research projects...

    By PharmaVoice Team • Feb. 12, 2009
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    Table of Contents

    We invite you to explore the digital edition of PharmaVOICE magazine. The interactive format allows you to easily read, share with friends, and click on podcasts, videos, webinars, whitepapers, and Website links to access additional resources. Getting started with your digital edition is this eas...

    By PharmaVoice Team • Jan. 28, 2009