life science connect's re-brand announcement

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.

More From Pharma Contributing Editors

PHARMACEUTICAL ONLINE VIDEOS

  • QbD: An Effective Roller Compation Process
    QbD: An Effective Roller Compation Process

    A description of the Roller Compaction process and the various process parameters that affect the quality of the roller compacted ribbons. Feed rate, compaction pressure, and roll speed are all discussed.

  • 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.

  • 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.”

More Videos

INDUSTRY NEWS

  • Life Science Connect To Launch Rebranding Initiative

    Life Science Connect media group is launching a new branding initiative for its products including Life Science Leader magazine, BioProcess Online, Clinical Leader, Drug Discovery Online, Laboratory Network, Outsourced Pharma, Pharmaceutical Online, Outsourced Pharma West Conference and Exhibition, the CMO Leadership Awards, the CRO Leadership Awards, and the Life Science Training Institute. 

More News

FEATURED SUPPLIERS

  • Micromeritics Instrument Corporation
    Micromeritics Instrument Corporation

    Micromeritics manufactures a broad line of automated analytical laboratory instruments that measure the physical characteristics of powders and solids for fundamental research, product development, quality assurance and control, production, and process control applications.

  • Fedegari Group
    Fedegari Group

    Fedegari Autoclavi SpA is the holding company of an Italian industrial group manufacturing customized machines, plants and the relevant components for the bio-/pharmaceutical and food industry worldwide. The know-how of the group lies in the field of sterile and clean processes and encompasses different technologies and products.

  • Weiler Engineering, Inc.
    Weiler Engineering, Inc.

    Weiler Engineering is America's leading provider of aseptic Blow/Fill/Seal liquid packaging machines for pharmaceutical and healthcare applications

INDUSTRY PARTNERS

 

 

PHARMACEUTICAL ONLINE SUPPLEMENTS

ABOUT US

The Information Source for the Pharmaceutical Manufacturing Industry

Welcome to Pharmaceutical Online, the premier sourcing site for the pharmaceutical manufacturing industry, find industry information on critical environment, particle sizing, pharma process control, pharma material handling, tablet production, pharma sterilizing, pharma cleaning, pharma filtration, pharma packaging, pharma inspection, & much more. Use our product showcase, and offline search service to expedite your discovery of new products and services. Our goal is to help buyers, like you, identify and select suppliers.

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PHARMA EXPO 2014

Just because the November debut of PharmaExpo is over, doesn’t mean the learning and networking has to stop.  

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 UPCOMING TRAINING COURSES

Monitoring Informed Consent (IC): Frequently Asked Questions

February 2, 2015
1pm-2:30pm EST, Online Training

Regulatory Affairs for Biologics – A Compliance Primer

February 4, 2015
1pm-2:30pm EST, Online Training

Surviving a FDA GCP Inspection – Preparation Techniques for Success

February 5, 2015
1pm-2:30pm EST, Online Training

FDA Guidance on Social Media: Questions Answered and Unanswered

February 10, 2015
1pm-2:30pm EST, Online Training

Strategic Clinical Project Management: Principles and Practical Applications

February 11, 2015
1pm-2:30pm EDT, Online Training
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LIFE SCIENCE WEBINARS

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PHARMA INDUSTRY INTERVIEWS

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 PHARMACEUTICAL EVENTS

Monitoring Informed Consent (IC): Frequently Asked Questions

February 2, 2015
1pm-2:30pm EST, Online Training

Pharma Commercial and SFE Summit, MENA

February 2 - 4, 2015
Dubai

Webinar On Risk Management and Risk-Based Monitoring

February 2, 2015
Mississauga, ON

12th Annual Medicare Congress

February 3 - 5, 2015
New Orleans, LA
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