• Pundits Forecast Pharma's Future

    18 April, 2017 MasterControl

    End of first-quarter economic reports are pouring in and the economic pundits are pondering the industry's performance in 2007 and forecasting the future of pharma in the remainder of 2008.

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  • How Will Personalised Medicine Have an Impact on Clinical Trials?

    Abel Ureta-Vidal, Managing Director, Eagle Genomics Ltd.

    How can genomics have an impact on the management of your clinical trials? With the growing understanding of genetic code within personalised medicine, could this signal a change in the size and scope of clinical trials? What does this mean for the pharma industry and the patient?

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  • The New Life Science Solution and its Implications on Document Management for Pharmaceutical Companies

    31 January, 2012 Dr. Gerhard Neurauter and Dr. Olaf Schoepke - EXTEDO

    The European Medicines Agency (EMA)(3) recently announced a new pharmacovigilance legislation (1, 2), describing how to modernize its pharmacovigilance system, how to improve patient safety and how to supply health information to patients. Considering the consequences on information management and business process, pharmaceutical companies have a very short timeline in which to adapt to and implement the initial phase. The attempt to define and establish the "Identification of Medicinal Product

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  • New Commercial Models for New Market Realities

    9 August, 2010 Chris Nickum, VP and Global Practice Leader, Commercial Effectiveness, IMS Health Management Consulting

    Maximizing the efficiency of commercial operations is standard fare for companies operating in a difficult economy and with budget constraints. Yet, because the pharmaceutical world is moving towards heavier commoditization, with 75-80 percent of mature markets expected to be undifferentiated by 2015, creating commercial efficiencies is no longer simply about managing costs - it's about devising a New Commercial Model (NCM) that better leverages available or yet-to- be-discovered approaches to

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  • Pharma Lifeline - FDA Report: Early and Effective Communication Key to First-Cycle Approval

    MasterControl

    Communication with FDA Key to Early NDA, BLA Approval

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  • Status Means More than Prestige in Lifecycle Management

    Lane Hirning, MasterControl's Product Manager and Pharmaceutical Industry Expert

    Lifecycles are normal states of nature. Plants, animals, and all manner of things are born, live useful lives and die.

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  • FDA Electronic Submissions, IT Changes Challenges

    18 April, 2017 MasterControl

    Where’s the hot spot at the Food and Drug Administration these days?  With product recalls, new hires at top levels and an impending election, there’s more than enough sizzling seats to go around at the Agency.  

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  • Value Adds to ISO 9001:2000 Compliance

    19 April, 2017 Sandford Liebesman

    There are three major ways 8.5.1 can be improved. Who is responsible for compliance to this requirement? Top management should have the responsibility. Also, there is no requirement for a process to accomplish continual improvement. Finally, how does one measure the effectiveness of the quality management system? Without a defined measurement of effectiveness it will be difficult to show improvement.

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  • Investigator Final Reports: A Tool for FDA Inspection Readiness

    Carl Anderson, Regulatory Affairs and Quality Assurance Consultant

    During the time I was an FDA field investigator I encountered many clinical investigators who were totally unprepared for the FDA inspection. I would receive a "deer gazing into the headlights" response from the PI who obviously didn't remember a thing about the audited study. There is an old saying, "you only get one chance to make a good first impression." Often they would turn to their study coordinator and ask for the answer, joking to me, "They do all the work anyway."

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  • Harmonization of Quality Groups and Automated Quality Audit Systems

    19 April, 2017 Chris Ball, AMGIT

    The term harmonization has become a buzzword in the life science sector and doesn't just refer to the harmonization of international standards created by various regulatory (or voluntary) bodies but can also refer to the harmonization of company-wide cultural and political differences as well as the harmonization of varying policies and procedures introduced by company mergers and acquisitions.

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  • Using Good Systems Practice to Right-Size IT Services for Emerging Biotech Firms

    19 April, 2017 Keith Parent and Christopher Port

    By Keith Parent and Christopher Port

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  • Four 'Dos and Don'ts' for Handling Warning Signs about an Approved Drug

    8 September, 2011 Brian S. Inamine and Michael F. Ruggio, Attorneys and Shareholders, LeClairRyan

    Faced with bad news about an approved drug (e.g. anything from a rise in reports of adverse reactions among patients to FDA notification that a warning letter is in the mail) pharmaceutical companies naturally tend to focus on the crisis at hand: Can this lucrative product stay on the market, or is a recall inevitable? And if the drug can be saved, what can companies do now to help keep it on the market? Such questions must be asked and answered because according to the trade publication, Gold S

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  • Investigating Clinical Trial Investigators Means More Headache for Drug Sponsors

    18 April, 2017 Michael McCaughan

    One leading indicator of a more enforcement-minded approach at the food & drug administration may be a crackdown on clinical trial investigators suspected of fraud. One thing is already clear: sponsors who rely on investigators who trigger suspicions will pay a price in the form of an even tougher time getting the drug through FDA.

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  • Pharmaceuticals: Articles / News

    MasterControl

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  • Pros and Cons of Proposed PDUFA IV User Fee Increase From FDA - For Pharmaceuticals

    MasterControl

    FDA Proposes PDUFA User Fee Increase to Boost Drug Safety

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  • From Poison Squad to Industry Regulator: A Historical Perspective of the FDA

    18 April, 2017 Robyn Barnes

    It hasn't always been this way. If you take a historical perspective, the FDA has been in the game for nearly 200 years.

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  • FDA Crisis: An Attrition of Brain Power

    Marci Crane

    If people are an organization's greatest asset, the FDA's current "people status" is one of serious attrition.

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  • Quality Control - Top Reason For FDA-483 Citations Among Drug Companies

    MasterControl

    If you're looking to improve a single area in your FDA compliance initiatives, look no further than your quality control unit (QCU). A report by an official of the Center for Drug Evaluation and Research (CDER) shows that QCU-related issues comprise the Number One reason why pharmaceutical companies receive FDA-483 citations.

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  • Top Reason for FDA-483 Citations - Pharmaceuticals

    MasterControl

    If you're looking to improve a single area in your FDA compliance initiatives, look no further than your quality control unit (QCU). A report by an official of the Center for Drug Evaluation and Research (CDER) shows that QCU-related issues comprise the Number One reason why pharmaceutical companies receive FDA-483 citations.

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