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  Pharmaceutical Technology Europe E-Alert
 
2 September 2011

IN THIS ISSUE
New EMA criteria
Nurofen Plus recall
USP & Brazil partner
FDA draft guidance

 
EMA to apply new electronic submission validation criteria
EMA announced in a press release that a new version of the validation criteria for electronic applications for human medicines comes into effect on Sept. 1, 2011. More...
 
Nurofen Plus recalled; sabotage suspected
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has issued a press release announcing that Reckitt Benckiser has recalled Nurofen Plus following the discovery of rogue medicines from different manufacturers in several packs. More...
 
USP and Brazil form partnership on public health education
USP and the Brazilian National Agency of Sanitary Surveillance (ANVISA) are teaming up to develop joint education activities for professionals involved in formulating and using pharmacopeial monograph standards in Brazil, according to news releases on the USP website. More...
 
FDA publishes draft guidance on tablet scoring
FDA has published a draft guidance that lists recommendations, new data and criteria requirements in new drug applications and abbreviated new drug applications for scored tablets. More...
 
Join our community on LinkedIn
Want to discuss any of this week's news stories or any other hot topics in the industry? Then why not join our group on LinkedIn? More...
 

Latest blog posts
Google's worldwide woes
A taste of someone else's medicine
Drug shortages encourage gray-market activity
More blog posts

Latest columns
Croatia, pharma and corruption
Offshoring biomanufacturing
Movin' on out
More articles

Upcoming events
European Congress of Chemical Engineering (25–29 September | Germany)
BioPharma Istanbul 2011 (29–30 September | Turkey)
Extractables and Leachables for Pharmaceutical Products 2011 (27–28 September | Ireland)
More events

Product/Service Profiles
Flexicon Liquid Filling

FF30 Aseptic Filling and Capping Machine
The new Flexicon FF30 aseptic filling and capping machine delivers a consistent level of production quality which is impossible to maintain with manual assembly of bottles and caps. Read more

 
Intertek

Strategic Approach to Glycoprotein and Glycosylation Analysis
Intertek and NIBRT are pleased to announce two free seminars covering the Characterisation of Glycoproteins. Read more

 
Powder Systems Ltd

New Lab Glass Filter Dryer Isolator Technology
Powder Systems Ltd’s (PSL’s) new GFD™ isolator combines the latest innovation to provide a high containment lab scale filtration and drying solution with the same reliability and benefits as PSL high containment production size filter dryers. Read more

 
Shimadzu

News in Polymer analysis: The new Multi-Shot EGA/PY-3030D pyrolyzer
Shimadzu and Frontier Lab provide a new versatile tool for the comprehensive analysis of polymer samples. It consists of Shimadzu’s GCMS-QP2010 quadrupole series and Frontier Lab’s new Multi-Shot EGA/PY-3030D vertical micro furnace pyrolyzer. Read more

 

Live Webcast

Preventing Costly Out-of-Specification Investigations
Tues, 20 Sept 2011, 11:00 EST, 4:00 PM BST
Join Dr. Charles Ray, former Associate Director of Analytical R&D at Bristol-Myers Squibb Co. and he will show you how to tackle 50% of the errors that cause Out-of-Specification results by streamlining sample/standards preparation. More information...


Event profiles

BIO-Europe® 2011—17th Annual International Partnering Conference
October 31-November 2 2011
Dusseldorf, Germany
The 17th annual BIO-Europe® event will be the largest biotechnology partnering conference held in Europe.Read more

 
 
Survey
What is your company's main driver for outsourcing biologics?
Cost control 39%
 
Technical capabilities 26%
     
Risk management 9%
     
Speed to market 26%

This week we would like to know...

Is quality by design changing the expectations between sponsor companies and contract service providers when outsourcing API development and manufacturing?

Click here to vote

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