FROM THE EDITOR

  • Compliance In The Supply Chain: 3 Best Practices To Manage Regulations Around The Globe
    Compliance In The Supply Chain: 3 Best Practices To Manage Regulations Around The Globe

    As if it isn’t challenging enough to maintain compliance with the regulation agency of the country you’re located in, anyone doing business in pharma also has to maintain compliance with any other countries for which they want to do business. Meeting the regulations of every point along the supply chain is necessary for both the manufacturer as well as the logistics provider who is transporting the product, but what is the best way to achieve this?

More From The Editor

OUTSOURCED PHARMA WEST CONFERENCE & EXHIBITION

  • Why We Took A Different Approach To Planning A Conference
    Why We Took A Different Approach To Planning A Conference

    Like you, I have attended a lot of educational events and conferences over the years. I’m sure we both could list some that were unique, valuable, and memorable while others could be simply categorized as “been there, done that.” And since time is my most precious resource, the last thing I want to do is spend this ever-diminishing asset on attending — or planning — a conference that’s just like all the rest.

More From Outsourced Pharma West

PHARMA MANUFACTURING INSIGHTS

More Pharma Mfg Insights

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

  • Global Study Reveals The future Of Temperature Control Packaging
    Global Study Reveals The future Of Temperature Control Packaging

    Sonoco ThermoSafe, a leading global provider of temperature assurance packaging, has revealed the results of its survey entitled “Assessing the Future of the Cold Chain Industry.” The survey highlights forward-looking trends in areas that significantly impact the cold chain industry – including environmental, trends, logistics and products and services. The survey’s 165 respondents spanned more than 20 countries and five continents.

  • Introduction to Multivariate Data Analysis
    Introduction to Multivariate Data Analysis

    Brad Swarbrick, Vice President of Business Development at CAMO Software, gives a short introduction to multivariate data analysis, discusses some of its applications and how these powerful analytical tools are being used to improve products and manufacturing processes in a wide range of industries.

  • Introduction to Pharmaceutical Bag Filling and Sealing Equipment
    Introduction to Pharmaceutical Bag Filling and Sealing Equipment

    Umbra bag filling and sealing machinery for all sorts of dry products in the food, pharmaceutical, chemical, and agricultural industries. A single Umbra packaging machine can fill bags of any material with varying fill weights and with different closure techniques, providing an extremely versatile solution to customers looking for high flexibility.

  • What Is mHealth? Video
    What Is mHealth? Video

    AT&T mHealth Solutions are on the cutting edge of transformation in healthcare and offer solutions that enable health enterprises to engage patients, improve outcomes and lower costs.

  • Real-Time Information On Microbial Contamination In Pharma Cleanrooms
    Real-Time Information On Microbial Contamination In Pharma Cleanrooms

    The BIOTRAK® Real-Time Viable Pharmaceutical Particle Counter from TSI provides real-time information on microbiological contamination in pharmaceutical cleanrooms.

More Videos

INDUSTRY NEWS

  • Meissner To Present At The IBC’s BioProcess International Conference & Exhibition!

    Max Blomberg, Meissner’s Director of Operations, will be presenting “The Importance of Automation in Conjunction with Single-Use Systems” in the BioProcess International Theater on Wednesday, October 22nd, at 10:10 AM. This presentation will focus on “smart” single-use mixing for critical processes, which combines the benefits of single-use mixing with automation historically only available in conventional systems.

More News

FEATURED SUPPLIERS

  • Charles Ross and Son Company
    Charles Ross and Son Company

    Ross serves the requirements of the Pharmaceutical industry, in virtually every industrialized country around the world. We have the experience and production capacity that no other manufacturer of specialty mixing and blending equipment can match.

  • Marken
    Marken

    Founded in 1980, Marken is focused on supporting Life Science companies assure the quality and integrity of clinical trial specimens and vital medications through the logistics chain. For nearly two decades, Marken has extended the reach of Pharmaceutical companies, research laboratories and clinical trial research organizations bridge the distance between patients and life science investigative resources.

  • Southwest Airlines Cargo
    Southwest Airlines Cargo

    At Southwest Airlines Cargo®, we understand the urgency of pharmaceutical shipments and know that sometimes overnight is not an option. With Relentlessly Reliable® air cargo service to over 90 destinations, we provide exceptional care so your time critical shipment will arrive ontime, as planned.

  • Capsugel
    Capsugel

    Capsugel offers capsules for the pharmaceutical and dietary supplement industries in multiple polymers — gelatin, HPMC, and pullulan.

INDUSTRY PARTNERS

 

 

LEADERSHIP AWARDS

Life Science Leader developed the CMO and CRO Leadership Awards based on industry leading research conducted by Nice Insight. The awards help pharma and biopharm companies focus on potential partners who can handle their projects and are considered reputable in the industry. Click on the logos above to visit this year’s winners.

 

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.

Pharmaceutical Online is part of the Life Science Connect media group. The vision of Life Science Leader and Life Science Connect is to help facilitate connections and foster collaborations in pharmaceutical and medical device development to find ways to get more life-saving and life-improving therapies to market in an efficient manner. Connect, Collaborate, Contribute. Please take a moment to join our community and discover the benefits of your free membership.

Newsletter Signup
Newsletter Signup
By clicking Sign Me Up, you agree to our Terms and that you have read our Privacy Policy.

PHARMA EXPO 2014

As the highly anticipated November debut of Pharma EXPO approaches, we’ve developed this resource center for our readers to access the most relevant information about the event. 

Learn More

 UPCOMING TRAINING COURSES

Clinical Finance: Key Strategies to Stay in Control of Your Study Budget

October 28, 2014
1pm-2:30pm EDT, Online Training

The Top Method Validation Mistakes – And How to Avoid Them

October 29, 2014
1pm-2:30pm EDT, Online Training

Process Validation: Ensuring Compliance With Multiple Standards

November 4, 2014
1pm-2:30pm EST, Online Training

Building An Effective GMP Training System: A Risk-Based Approach

November 10, 2014
1pm-2:30pm EDT, Online Training
More Upcoming Courses

LIFE SCIENCE WEBINARS

More From Life Science Webinars

PHARMA INDUSTRY INTERVIEWS

More...

 PHARMACEUTICAL EVENTS

Clinical Statistics for Non-Statisticians

October 23 - 24, 2014
London

imee c

October 27 - 28, 2014
Singapore

BioNetwork 2014

October 27 - 29, 2014
Laguna Niguel, CA
More Events....

TWITTER FEED: @PHARMAONLINE

Feed Image
RT @PharmTechGroup: Expert from J&J's Janssen discusses global regulatory compliance for product registrations. Free June 11 webcast. http…
3 hours ago

06.11.13 -- Temperature Monitoring Comparisons For The Pharmaceutical Supply Chain http://t.co/e1V7cIbFul
3 hours ago
More...