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  Pharmaceutical Technology Europe E-Alert
 
17 September 2013
IN THIS ISSUE
News
Webcasts
Events
About Us
 
Featured Topics
FDA Specifies Unique Facility Identifier System
FDA specifies the DUNS UFI system for registration of domestic and foreign drug establishments. More...
 
Hovione Receives Patent Approval for XCaps DPI
The device is an inexpensive, easy-to-use capsule-based DPI with high efficiency powder dispersion and has the versatility to treat a range of pulmonary diseases. More...
 
First biosimilar mAb approved in Europe
Hospira's Inflectra (infliximab), which is a biosimilar to the reference biologic product, Remicade, has been approved by the EC for the treatment of inflammatory conditions. More...
 
Industry News
Regulatory Authorities Discuss Elemental Impurities Standards
Regulatory authorities discuss elemental impurities standards. More...
 
FDA Announces More Compounding Pharmacy Recalls
FDA inspections reveal possible inaccurate sterility testing. More...
 
FDA Announces Safety Requirements for Opioid Analgesics
FDA revises boxed warnings for extended-release and long-acting opioid analgesics and postmarket study requirements. More...
 
EFPIA Responds to EMA Policy on Publication and Access to Clinical-Trial Data
The association representing the research-based pharmaceutical industry in Europe is concerned that an EMA policy will put transparency ahead of public-health interests. More...
 
Takeda's Drug Vedolizumab is Granted Priority Review Status by FDA
Takeda's drug vedolizumab is granted priority review status for the treatment of adults with moderately to severely active ulcerative colitis. More...
 
FDA Reissues Bioanalytical Method Validation Guidance
FDA updates guidance to reflect advances in technology. More...
 
MPI Research Breaks Ground on New Imaging Center
MPI's new Imaging Center is set to open in Spring 2014 at the company's headquarters in Michigan. More...
 
FDA Advisory Committee Recommends Approval for GSK and Theravance's COPD Drug
An FDA Committee voted to support approval of GSK and Theravance’s umeclidinium/vilanterol for treatment of chronic pulmonary disease. More...
 
Webcasts
Meeting Regulatory and Technical Requirements for Organic Impurity Analysis
Tuesday, September 24, 2013 at 11:00 AM EDT for the US and October 1, 2013 at 15:00 CET for Europe
Sponsored by: SGS Life Science Services
 
Improving Cell Culture Productivity: Best Practices for Automation and Control
On Demand
Sponsored by: Parker Hannifin
 
More Webcasts

Products/Services Profile
Agilent
Do More Together with Open Access Solutions
Agilent’s open access solutions enable pharmaceutical scientists to accelerate discovery by simplifying the management of multiple LC/MS and NMR instruments. New MassHunter Walkup Software allows analytical chemists to easily configure and maintain multiple MS instruments, spending more time doing other work. New Vnmr J 4 Persona Manager provides NMR facility managers with a flexible platform for managing multiple users and spectrometers. Attend a webinar. www.agilent.com/chem/togetherpharma#openaccess
Rapid Micro Biosystems
Automated analysis in microbiology eliminates error-prone manual steps and saves labor; rapidly detecting contamination enables manufacturers to reduce inventory carrying costs, shorten manufacturing cycle time, and reduce product losses. Read more
SignTrade Melapahone
MELAPHONE VISAUDIO – When you need to talk
The Melaphone is designed to be used indoors or outdoors for good two-way communication. It is secure, hygienic, simple, easy to fit, no wires and tried and tested over 30 years. Read more

Event Profile
PharmaProcess
Fira de Barcelona launches PharmaProcess, Europe’s first forum on the pharmaceutical industry’s processes
Fira de Barcelona’s Montjuïc Congress Hall will host on 29th and 30th of October PharmaProcess, an international forum at the service of the pharmaceutical industry. Its first edition is convening this industry’s most important experts to reveal the sector’s latest technical advances in a programme consisting of two plenary sessions and various conferences. Read more

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Spotlight Event

Validation Week
Industry's Most Comprehensive Event Dedicated to Validation Practice

Oct. 22-24, 2013
San Diego, CA

> Brochure
> Register

Other Validation Events
Method Development and Validation
a part of Lab Compliance Week
December 3-5, 2013 | Philadelphia, PA

More in GMP/Validation


Reference Library

Pharmaceutical Technology presents its Analytical Testing Resource Guide combo
A compilation of articles in a three-handbook set covering general Analytical Testing and Stability in the manufacture, packaging, storing, and testing of formulated products. ... Click here


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