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12 November 2013

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IN THIS ISSUE
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Featured Topics

Ensuring Compliance with Drug Accountability Requirements An expert discusses regulatory requirements for the drug accountability process. More...

Q&A with Amie Gehris, Dow Water and Process Solutions Amie Gehris of Dow Water and Process Solutions discusses formulating abuse-deterrent drugs. More...

Tracking Quality in Drug Manufacturing Recent FDA enforcement activity reveals issues with vial-filling, adequacy of QA/QC procedures, particulate matter in inhalation powders and injectables, and drug labeling. More...

Video: Impact of the Affordable Care Act on Biopharm Manufacturing Jill Sackman of Numerof and Associates discusses the impending impact of Obamacare on the pharmaceutical and biotech industries. More...

Industry News

J&J Fined $2.2 Billion for Off-label Marketing and Kickbacks Allegations include off-label marketing for Risperdal, Invega and Natrecor and kickbacks to doctors and pharmacists. More...

EMA and FDA Release QbD Guidance EMA and FDA publish joint QbD guidance on design space verification. More...

FDA Releases Pulmonary Tuberculosis Guidance FDA releases guidance on pulmonary tuberculosis drugs. More...

ISPE Releases Report on Survey of Patient Experiences with Clinical Trial Materials ISPE’s survey is industry's first large-scale effort to collect data on patient experiences with clinical trial materials. More...

Novartis Announced as Facility of the Year Awards Overall Winner ISPE names Novartis’ US Flu Cell Culture facility as award winner. More...

EMA Releases New Guidance on Antibacterial Development Includes a new approach on developing antibacterial agents targeted against multidrug-resistant (MDR) pathogens where patients have very limited or no remaining treatment options. More...

BIO Throws its Support for Start-up Jobs and Innovation Act Biotechnology Industry Organization President James Greenwood writes senators in support of Start-up Jobs and Innovation Act. More...

Webcasts
Optimizing Quality by Design in Bulk Powders and Solid Dosage On Demand Sponsored by: Hovione

A Quality by Design Approach for Stability Testing On Demand Sponsored by: Decagon

Optimizing Validation/Mapping Studies for GMP Compliance On Demand Sponsored by: Vaisala

More Webcasts

Products/Services Profile

LB Bohle

The Bohle Fluid Bed System offers numerous advantages and various options in the pharmaceutical production without alteration of equipment setup. Through the tangential-spray technology, this processing design is much more robust than traditional Wurster technology. Read more.

Shimadzu

Method Scouting Solution
Since the introduction of UHPLC, strategies for fast method development are being discussed.
A wide variety of columns with different separation properties is available, offering the user a number of columns suited to a specific application. Read more.

Tosoh Bioscience

Setting new Benchmarks for Antibody Analysis
Tosoh Bioscience expands the renowned TSKgel SW series of aqueous size exclusion HPLC columns by three new UHPLC columns, tailored to different aspects of antibody analysis. Read more.

Reference Library

Pharmaceutical Technology Outsourcing Guide
Pharmaceutical Technology Outsourcing Guide provides details behind recent partnerships, strategies for selecting an appropriate CDMO/CMO, and quality by design factors for outsourced operations. ... Click here

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