Policy & Regulation: Page 25

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    What's New

    Roche Introduces New Operating Model for its Global R&D Activities The focus is on disease biology areas to enhance alignment of R&D. Roche has introduced a new operating model for its global R&D activities, organized around disease biology areas (DBA). Each DBA covers a range of acti...

    By PharmaVoice Team • Jan. 2, 2008
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    PharmaOutlet

    Contributed by Nancy Smerkanich The U.S. Food and Drug Administration (FDA) called a Part 15 (21 CFR Part 15) hearing on Dec. 18, 2006, primarily as “a listening exercise” to gather information so that the agency could move forward to “an all electronic submission environment and electronic data ...

    By Nancy Smerkanich • Jan. 2, 2008
  • drug shopping cart Explore the Trendline➔
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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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    Table of Contents

    Table of Contents April 2007 On the Cover The Evolving Role of the Clinical Project Manager Clinical studies have become more complicated, are multinational, and must adhere to a variety of laws and regulations. As a result, the project manager role has become a core capability needed for drug de...

    By PharmaVoice Team • Jan. 2, 2008
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    Going Public: Pharma's Commitment to Public Health

    By Elisabeth Pena Villarroel Forum The pharmaceutical industry’s commitment to public health is at the core of its very existence; the mission and work of the industry’s companies are to create, develop, and bring to market lifesaving and life-enhancing medicines. A natural extension of this miss...

    By PharmaVoice Team • Jan. 2, 2008
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    The Evolving Role of the Clinical Project Manager

    The Evolving Role of the Clinical Project Manager By Denise Myshko Forum Clinical studies have become more complicated. More studies are multinational, which means that projects must adhere to a variety of regulations and laws. Today’s studies also require project managers to work across teams to...

    By PharmaVoice Team • Jan. 2, 2008
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    Talent Pool

    Pharma POOL Dr. Eric G. Carter King Appoints Chief Science Officer King Pharmaceuticals, Bristol, Tenn., an integrated branded pharmaceutical company, has appointed Eric G. Carter, M.D., Ph.D., as chief science officer. Dr. Carter oversees King’s R&D, regulatory, and medical-affairs activitie...

    By PharmaVoice Team • Jan. 2, 2008
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    Meet the Creative Directors

    By Taren Grom, Editor Special Feature PharmaVOICE is pleased to publish this special feature showcasing the individuals who influence the look and feel of the industry through their creative executions and insights, strategic thinking, and mentorship of up-and-coming talent. GETTING PERSONAL ABOU...

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

    Thomson Scientific Expands Pharmaceutical Regulatory Intelligence Coverage Thomson Scientific announces that three new country modules, India, Israel, and Turkey, are now available in IDRAC, the global pharmaceutical regulatory intelligence database. IDRAC is recognized by regulatory professional...

    By PharmaVoice Team • Jan. 2, 2008
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    PharmaOutlet

    Contributed by James Rogers Merging Clinical-Trials Safety and Pharmacovigilance The Winds of change in safety monitoring In November 2003, Mark B. McClellan, M.D., Ph.D., a former commissioner with the Food and Drug Administration, made the comment: “…there is no such thing as a completely safe ...

    By James Rogers • Jan. 2, 2008
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    Raise Your Voice -- Letters

    Changes in Washington: Will it Affect the Pharmaceutical Industry? One way that the U.S. government is making good on its promise to reduce the cost of healthcare is by approving Medicare Part D. — Patricia Santos-Serrao, RAC, Regulatory Advisory, Qumas A shift in command Healthcare has always be...

    By PharmaVoice Team • Jan. 2, 2008
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    Managed Markets: Formularies

    By Denise Myshko MCOs and PBMs are now applying their cost-management strategies to biotech and specialty drugs. Biologics and injectable medications are coming under increased scrutiny by managed care organizations (MCOs). MCOs, pharmacy benefit management companies (PBMs), and other payers are ...

    By PharmaVoice Team • Jan. 2, 2008
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    FDA: An Agency in Transition

    In the past year, the Food and Drug Administration has built some momentum in speeding drug development and addressing product safety. Despite the progress made in improving its internal structure, the agency in the coming year will continue to face obstacles. Robert DeLuccia MacroChem A shifting...

    By Denise Myshko • Jan. 2, 2008
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    UpFront

    Top 7 Healthcare Issues This year is expected to be a watershed period for the health industries, according to PricewaterhouseCoopers LLP, as health savings accounts reach a tipping point, states act where the federal government hasn’t, and pressure on pricing amid demand for transparency forces ...

    By PharmaVoice Team • Jan. 2, 2008
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    Counter Measures: Switching from Rx to OTC

    Switching products from Rx to OTC status can be a viable life-cycle management strategy, one that is expected to be used more frequently. By Cynthia Borda Consumers are increasingly comfortable managing their own healthcare. They want easy access to low-cost, effective, safe, and easy-to-get prod...

    By Cynthia Borda • Jan. 2, 2008
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    Registering Safety

    By Kim Ribbink As the emphasis on drug development shifts toward improving risk management, new tools have emerged to evaluate safety both pre- and postapproval. Increasingly, companies are looking at patient registries as an integral part of their safety arsenal. Drug safety has become the focal...

    By Kim Ribbink • Jan. 2, 2008
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    Letter from the Editor

    Already 2007 is shaping up to be an interesting time. A new Congress, shifting demographics, regulatory restrictions, and other factors are sure to keep industry leaders on their toes. In early December, Pfizer’s two big announcements made headlines: first, a major reduction in its salesforce, th...

    By Taren Grom • Jan. 2, 2008
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    E-Media

    New Electronic and Web-based Applications, Sites, and Technologies Phase Forward Expands Clinical-Trials Signal Detection System Phase Forward has unveiled a new version (2.0) of its clinical trials signal detection system — CTSD. The CTSD system enables clinical safety and medical monitoring sta...

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

    BBK Launches E-Business Suite of Tools for Patient Recruitment Pharmaceutical, medical-device, and biotechnology companies can now take advantage of BBK Worldwide’s TCN e-Systems, a licensable e-business patient-recruitment solutions offering. With TCN e-Systems, study sponsors have greater contr...

    By PharmaVoice Team • Jan. 2, 2008
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    Sales & Marketing Compliance: Keeping up with Global and Local Challenges

    As pharmaceutical manufacturers continue to refine and adjust their compliance policies to meet a slew of regulations enacted over the past five years, they also are looking ahead and preparing for regulatory changes that could create many challenges. Six states have legislation that require phar...

    By PharmaVoice Team • Jan. 2, 2008
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    Then & Now

    Year in Preview Prognostications for the future PharmaVOICE asked several experts who participated in the December 2005 issue to review what they predicted for 2006. We wanted to know if indeed their prognostications for the future came true. In some cases, they were right on, and in other instan...

    By PharmaVoice Team • Jan. 2, 2008
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    UpFront

    Year in Preview FAST FACTS The Industry at a Glance In 2007, the market will be absorbing changes that have defined a new economic reality, one in which growth is shifting from mature markets to emerging ones; new product adoption is not keeping pace with the loss of patent protection by establis...

    By PharmaVoice Team • Jan. 2, 2008
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    Partnerships For Success

    Year in Preview Strategic Alliances Strategic alliances — between pharmaceutical companies, contract research organizations, and other outsourcing providers — are expected to impact the future of drug development. Pharmaceutical companies are under pressure from the public, analysts, Wall Street,...

    By PharmaVoice Team • Jan. 2, 2008
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    What's New

    GSW Launches Pink Tank Specialty marketing group offers expertise in understanding and speaking to women. Remarkably, many marketers don’t realize that women connect with brands differently from men. We established Pink Tank to help companies understand those differences and to counsel them on ho...

    By PharmaVoice Team • Jan. 2, 2008
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    PharmaTrax

    Sales, Marketing, and R&D Trends from Industry Analysts Technology Use Among Regulatory Affairs Professionals Rising Many regulatory affairs professionals rely on both paper and electronic submissions, and 70% of these professionals expect this trend to continue into the future, according to ...

    By PharmaVoice Team • Jan. 2, 2008
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    Talent Pool

    Executive Appointments and Promotions Pharma POOL Manoj Aggarwal James Bongi Jeffrey Chodos Colette Curran Brian Doyle Dr. Sean Fenton Patrick Grenyo Lloyd Hilton Taewon Kim Paul Korathu Michelle LaBonte Marcia Leishman Carter McBride Dr. Eran Nadav Bud Powell Kenny Rankin Peter Rossmann Kelly St...

    By PharmaVoice Team • Jan. 2, 2008