FROM THE EDITOR

  • Bayer Change Notification Process For Raw Material Supply Encourages Supplier Collaboration And Transparency
    Bayer Change Notification Process For Raw Material Supply Encourages Supplier Collaboration And Transparency

    When it comes to raw material supply, increased regulatory focus on the raw material supply chain is creating a transformational change in the industry. Because of this, quality agreements create a responsibility among suppliers to notify their partners with advanced notice any time a change is made to the raw materials those partners are receiving. To ensure change notifications are handled properly and evaluated thoroughly, Bayer Healthcare utilizes an internal process that allows notifications to be filtered to the appropriate stakeholder and reviewed thoroughly before action is taken. Albert Obrero, Jr., Senior Project Specialist at Bayer HealthCare, recently presented the Bayer process to an audience at Bioprocess International 2014, where he outlined how it works as well as its benefits.

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PHARMA MANUFACTURING INSIGHTS

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PHARMA CONTRIBUTING EDITORS

  • The Challenge Of Managing Regulatory Submissions & Correspondence

    Life science organizations produce large volumes of documents necessary for submitting applications to regulatory agencies. They need to have records of those documents as well as all related communications from sites around the world. This creates a situation that can be rather daunting.

    Sponsors must first make sure all documents are going through the proper review and approval cycle and that controls are in place to meet regulatory requirements such as 21 CFR part 11. Once the documents are published and ready for submission to the regulatory agency, they are typically stored on a file share. Although that file share has access controls in place, it will not have granular-level access controls.

  • ISPE Releases Drug Shortages Prevention Plan At Annual Meeting

    ISPE has released its Drug Shortages Prevention Plan at a media conference held during its annual meeting at Caesars Palace in Las Vegas. Present at the conference were new president and CEO John Bournas, strategic advisor John Berridge, and Drug Shortage Prevention Plan leaders Joe Famulare, Paul D'Eramo, Donna Gulbinski, and Sam Venugopal.

  • ISPE Set To Address Drug Shortages At Annual Meeting

    Drug shortages continue to plague the pharmaceutical industry. According to a GAO report on shortages, dated February 2014, the number of shortages continues to increase in the U.S., as well as around the world. In 2007 there were 154 shortages, 114 new shortages and 40 ongoing from a prior year. In 2012, there were 456 shortages, 195 news ones and 261 ongoing. As of June 30, 2013, there were already 73 new shortages and 288 ongoing.

    The public health importance of these shortages cannot be overemphasized. Shortage situations have included zinc for parenteral nutrition in neonates and premature infants, doxorubicin for ovarian and other cancers, and Propofol for anesthesia.

    Clearly something needs to be done. “ISPE believes efforts to address this complex and multi-faceted problem of drug shortages requires close collaboration and clear communication between the pharma industry and global health authorities,” says Francois Sallans, VP and chief quality officer for Johnson & Johnson, and presenter at the 2014 ISPE-FDA CGMP Conference. “We believe The Drug Shortages Prevention Plan being assembled by ISPE will provide guidance to pharma and global health authorities to manage drug shortages more effectively. But more importantly we are looking into ways for the two groups to manage these shortages more proactively as well. That is an important component that we need to have in place in order to make these shortages rare, but short-lived.”

  • What Can You Learn From The Educational Planning Process Of BIO?

    In my role as the 2015 co-chair of the BIO International’s educational planning committee, I am privy to what goes into creating one of our industry’s largest annual events. As many of you are involved in organizing your own customer educational programs (e.g., The Emerson Exchange) or have been asked to serve on an event planning committee, I thought a behind the scenes look into how BIO goes about the process would be helpful to your efforts. Here are some of the best business practices I have witnessed thus far.

  • Innovation In Clinical Trials: Is It Time To Change The Paradigm?

    “People hate change. This is true in the life sciences industry and everywhere in the world. I think it’s a major, major problem.”

    That statement, by Glen de Vries, president of Medidata, seems to sum up the challenge many have with trying to bring down the cost of clinical trials. To bring down costs we need to implement new, efficient, and available technologies. Unfortunately implementing new technologies involves change, which many people in this industry do not seem to want to embrace.

    Hopefully, that attitude may soon be changing. One of the trends de Vries has seen in the past year is a focus on innovation originating at the executive level. More managers, especially those in the C-suite, are saying we need to figure out how to do things differently.

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PHARMACEUTICAL ONLINE VIDEOS

  • Quality and Manufacturing Complete Control- Keeping Documents on Track
    Quality and Manufacturing Complete Control- Keeping Documents on Track

    Trying to keep track of up-to-date documents and templates can be like chasing down…well you know. But with EMC Documentum Quality and Manufacturing time-consuming reviews and approval efforts can be minimized with centralized control and a unified document repository- all while adhering to GMP compliance and mitigating risks and delays.

  • R&D Submissions Ready- The Mission Control from EMC Documentum
    R&D Submissions Ready- The Mission Control from EMC Documentum

    EMC Documentum Research and Development delivers the control and collaboration needed to sit in the mission control seat. With predefined taxonomies, workflows and templates you can ensure both compliance and up-to-date regulatory submissions.

  • R&D Collaboration- Elevated by EMC Documentum
    R&D Collaboration- Elevated by EMC Documentum

    Collaboration in research and development can be hindered all too easily. With EMC Documentum Research and Development, predefined taxonomies, workflows, templates in concert with collaborative editing and reviewal processes can take your collaborative capabilities to an all new level.

  • It Might Look Like Just A Box - But It's A Lot More Than That
    It Might Look Like Just A Box - But It's A Lot More Than That

    Envirotainer R&D continuously strives to improve reliability – it is core of all our operations. As a market leader, Envirotainer also takes on the role of driving innovation of existing products and solutions for the future.

  • Cold Chain Open House 2014 Webinar
    Cold Chain Open House 2014 Webinar

    Camille Madelon, Strategy and Business Development Director, states, “The industry needs innovation to stay competitive and relevant in the future – to meet new demands, for example due to changing regulations, emerging markets and new drug segments such as personalized medicine.”

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FEATURED SUPPLIERS

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    Lighthouse Instruments We are the leading provider of non-destructive, optical-based research, at-line and in-line detection systems to the pharmaceutical, biotechnology and contract manufacturing industry. All of our systems utilize Lighthouse’s patented optical spectroscopy technology that provides for the fast and accurate detection of headspace oxygen as well as the simultaneous detection of headspace moisture and pressure in sealed parenteral containers.
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    Pall Corporation is a specialty materials and engineering company with the broadest-based filtration and separations capabilities in the world|We serve a diverse, global customer base with products that are used to purify raw materials, keep equipment running efficiently, ensure product quality and clean up and minimize waste

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Identifying and Closing the Training Gap in Clinical Research

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Pediatric Clinical Trials: Special Considerations and Requirements

January 12, 2015
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