• 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.

    Full story
  • 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

    Full story
  • 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

    Full story
  • 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.

    Full story
  • 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."

    Full story
  • 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.

    Full story
  • 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.  

    Full story
  • 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.

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

    MasterControl

    Communication with FDA Key to Early NDA, BLA Approval

    Full story
  • 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

    Full story
  • 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

    Full story
  • 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?

    Full story
  • 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.

    Full story
  • Preparing for a Safety Inspection

    12 July, 2011 Steve Jolley, Subject Matter Expert, Global Safety Compliance and Signal Detection

    This article will be published in the September 2011 issue of the Drug Information Journal. Copyright © 2011, Drug Information Association.

    Full story
  • 7 Critical FDA Concepts for Pharmaceuticals Quality Systems

    MasterControl

    From the discovery of penicillin in the late 1920s to the breakthrough anti-cholesterol and anti-HIV drugs being manufactured today, the pharmaceutical industry has always been in the front line of developing new technologies. But the industry has yet to fully embrace modern quality systems operations.

    Full story
  • Reducing Human Error on the Manufacturing Floor

    15 June, 2010 MasterControl

    As technology advances, human error in manufacturing becomes more and more visible every day. Human error is responsible for more than 80 percent of process deviations in the pharmaceutical and related manufacturing environments. Sadly, little is known about the nature of these events mainly because quality event investigations end where human error investigations should begin.

    Full story
  • Taming the Regulatory Beast: Role of Regulatory Trend Analysis in Successful FDA Approval

    18 April, 2017 Mukesh Kumar, PhD, RAC, Senior Director, Regulatory Affairs, Amarex Clinical Research, Germantown, MD

    The biggest risk in drug development is failure to convince the FDA that your product meets the requirements for marketing approval. By the time a company files a New Drug Application (NDA), it believes that sufficient evidence is available in support of the marketing approval, based on its understanding of the regulations and requirements. However, about 40% of the NDAs submitted to the FDA are rejected for one or another reason while more than half go through multiple cycles of review adding a

    Full story
  • Speeding Time To Market For Pharmaceutical & Biotechnology Companies

    Antoinette Azevedo, President & CEO, e-SubmissionSolutions.com

    Pharmaceutical, biotechnology and medical device companies that market blockbuster products can earn over $1 billion dollars per year once their products are approved for sale by the United States Food and Drug Administration (FDA). Approval by the FDA can result in rapid approval to market products on a global level. Companies can invest $1 billion dollars or more over the course of the discovery, research, and development phases of their product candidates. Patent protection can be extended

    Full story