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PDA's 7th Annual Global Conference on Pharmaceutical Microbiology
October 22, 2012–October 24, 2012
Bethesda, Maryland
ICH Q9 Training Course
October 24, 2012–October 25, 2012
Vienna, Austria
ICH Q10 Training Course
October 25, 2012–October 26, 2012
Vienna, Austria
European Pharmaceutical Pricing & Reimbursement
October 29, 2012–October 30, 2012
London, United Kingdom
The New FDA/EU Approach to Process Validation
October 30, 2012–October 31, 2012
Barcelona, Spain
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New USP Standards Guide Prescription Container Labels
New US Pharmacopeial Convention standards provide a universal approach to organizing labels for prescription containers dispensed by US pharmacists in an effort to improve patient understanding.
Novasep to Build the World's Largest Chromatography Plant
Novasep announced that it will be investing EUR 30 million ($39 million) to build what will be the world’s largest chromatography plant for the production of large volumes of commercial APIs.
Teva Opens New Sterile Plant in Hungary
Teva has invested $110 million in a new sterile plant in Hungary. The company hopes the plant will strengthen the company's role in Hungarian drug development.
GSK Encourages Open Innovation and R&D
GlaxoSmithKline has outlined the measures it is taking as part of a new open innovation approach to R&D, including opening up its tuberculosis compound library, investing in its open laboratory in Spain, and sharing detailed clinical trial data with researchers.
Grad Student Research Sparks Innovation through AAPS Awards
At this week’s AAPS 2012 Annual Meeting in Chicago, graduate students across the country are being honored for their research and work in bio/pharmaceutical innovation. Pharmaceutical Technology had the chance to talk with a few of the recipients.
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 Asset management system offers condition-based monitoring capabilities
Honeywell Process Solutions’ Asset Manager R410 version offers real-time, condition-based monitoring of equipment to assist in maintenance and reliability planning. The system integrates with IBM’s Maximo and SAP enterprise asset management and computerized maintenance management systems. This integration allows maintenance and reliability planners to review the status and priority of equipment health and the severity of any failures, assign resources as well as raise and track work orders directly from Asset Manager. In addition, Honeywell’s newest version of its Field Advisor tool, which helps mobile workers prioritize and execute field tasks, has been refreshed to provide efficient automation for rounds and inspections.
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Catalent Pharma Solutions has taken an exclusive license to taste-masking technology developed by the New Jersey Institute of Technology. Under the terms of the license, Catalent will complete transfer of the technology into its cGMP facilities to support manufacture of dosage forms such as its Zydis fast-dissolve platform. Read More
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Caron's Photostability Chambers ideal for forced degradation
Caron's Photostability chambers feature a benchtop size and are designed in accordance with ICH Q1B guidelines. Uniform light distribution and high intensity levels allow for quick response forced degradation testing and confirmatory studies. To learn more and to download our white paper "Using Photostability Chambers to Meet the Requirements of Drug Testing in Accordance with ICH, Q1B" visit .
 www.caronproducts.com/photostability |
On Sept. 20, 2012, an investigator from FDA visited MicroConstants’ San Diego, California, facility for a routine inspection to assess the CRO’s overall compliance with good laboratory practice regulations. During the visit, the investigator toured the facility and laboratory areas and reviewed several method validations, three sample analysis projects, and a pharmacokinetic analysis report. Upon completion of the inspection, the investigator reported zero findings, observations, or recommendations. Read More
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Realize Effective Pharmaceuticals
Reliable solutions enable pharmaceutical scientists to innovate in disease research, accelerate drug discovery and have greater confidence throughout development and manufacturing. Agilent solutions in genomics research, automation, separation and detection technologies along with workflow driven software solutions helps deliver the answers to bring effective therapeutics to market. Learn more at  www.agilent.com/lifesciences/realizepharma |
Recipharm and Astimex Pharma have announced the formation of a collaboration agreement for the development and manufacture of a pharmaceutical product. The formulation development work will take place at the Recipharm Pharmaceutical Development site in Solna, Sweden. Astimex Pharma also has the opportunity to choose Recipharm as the future manufacturer for the product. Additionally, Astimex is in discussions with Recipharm for engagement to carry out other manufacturing and development contractual projects. Read More
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Agilent ICP-MS/ICP-OES
Reliable solutions for regulated pharmaceutical laboratories
Complying with new elemental impurity limits as defined by draft USP methods <232>/<233> could pose a significant challenge. You need to choose qualified hardware and software, ensure verification, and maintain electronic records. But there is a simple answer –  Request a free copy of our primer on Elemental Impurity Analysis to learn more. |
A roundup of additional company and people news from pharmaceutical and biopharmaceutical companies, their suppliers, and contract-service providers. Read More
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Best Practices for Achieving Product Quality in Sterile Manufacturing
Live Webcast: Tuesday, November 6, 2012 at 11:00am–12:00pm EST
Register Free at  www.pharmtech.com/achieving |
Do you have news to report on facility expansions, contracts, service agreements, mergers, acquisitions, or personnel appointments? Send press releases to ptpress@advanstar.com |
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The European Medicines Agency has opened public consultation on the revised CHMP Guideline on the Clinical Investigation of Medicinal Products for the Treatment of Acute Heart Failure (CHMP/EWP/2986/03 Rev.1).
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Overcoming Formulation Challenges of Parenteral Drugs
Live Webcast: Tuesday, October 30, 2012 from 11:00 AM EST to 12:00 PM EDT
Register Free at  www.pharmtech.com/parenteral |
EMA also released its guideline on medicinal products for the treatment of schizophrenia on Oct. 9, 2012. The guideline describes requirements for the development of medicinal products with regard to study design, patient population, and outcome measures and goes into effect on Apr. 1, 2013.
FDA has collected generic drug information and made it available on their website for industry. The website include guidance document updates, recent meeting minutes, reports, and other relevant information.
Recent guidance documents published by FDA include E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs. Questions and Answers (R1) (October 2012). A comprehensive list of FDA guidance documents can be found on www.FDA.gov and well as a list of withdrawn guidance documents.
The Orange Book, the Approved Drug Products with Therapeutic Equivalence Evaluations, has been updated with additions and deletions of prescription and OTC products.
The International Conference on Harmonization has released the final meeting report from the latest Global Cooperation Group meeting held in Fukuoka, Japan on June 5, 2012.
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Please take a moment to complete Pharmaceutical Technology's annual employment survey, and tell us about your job—tell us how satisfied you are, and what you hope to find in the job market in the future.
Results of the survey will be published in the December 2012 issues of Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International. Those completing the survey will be entered to win one of three $100 Amazon.com gift certificates.
Thanks for your participation!
From the Editors of Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International.
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Know Before You Go—2012 Conference Previews
Visit our Show & Exhibition Gateway 2012 to see which companies are exhibiting at upcoming industry conferences.
Find company backgrounds, new product releases, booth materials, and more.
PharmTech's online
Gateway is your guide to the season's leading shows.
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