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  Pharmaceutical Technology Europe E-Alert
 
JUNE 12, 2009

IN THIS ISSUE
EU generic medicines
Authorized generics
PTE June
EC excipient GMPs

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Europe needs faster generic medicines uptake
"EU governments need to ensure fast generic medicines uptake as market access and low market volume in key EU countries is still a real problem and is having a major negative impact on patient access to more affordable treatments." More...

Brand makers abusing authorized generics?
The Chief Operating Officer (COO) of one of the world’s largest generics manufacturers has condemned the launch of authorized generics during 180-day exclusivity periods. More...

Have you seen…?
The June issue of Pharmaceutical Technology Europe? This issue features articles on substandard APIs, mass serialization and improving liposome integrity. More...

EC won't pursue directive for excipient GMPs
The European Commission’s (EC) Directorate-General for Enterprise and Industry (EC-DG Enterprise) announced last week that it will not continue preparing a commission directive on good manufacturing practices (GMPs) for certain excipients. More...

MHRA seeks improved legislative framework
The outcome of a concept paper by the UK's Medicines and Healthcare products Regulatory Agency (MHRA), which sought the input of stakeholders on the review and consolidation of the UK medicines legislation, has been published. More...

EU-wide recall of Raptiva
The European Medicines Agency (EMEA) has agreed to an EU-wide recall of all the remaining batches of Merck Serono's Raptiva because of the risk of a serious brain infection. Following the recall, the medicine will no longer be available anywhere in the European Union. More...

New centre for research opens in UK
A new Faculty of Translational Medicine has been established in London (UK) that will increase support for, and enhance collaboration among, researchers as they search for new treatments and diagnostic tests for a range of diseases and conditions. More...

Biologic manufacturing facility to be built in India
India-based Kemwell plans to build a new biopharmaceutical manufacturing plant in Bangalore (India) in a strategic collaboration with Boehringer Ingelheim (BI, Germany). More...

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Follow Pharmaceutical Technology Europe on Twitter! More...

Event Profile
Chemspec
There's something special about Chemspec Events that exhibitors and visitors enjoy above all other shows. It's just a much more manageable and pleasant experience for all. With a focused range of exhibits, easily identified zones and villages, a relaxed, informal, atmosphere with quality "face time", there's no more direct or attractive place for taking orders.
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Product Profile
Gyros
Accelerate your therapeutic protein development in a GxP environment
A 45-minute webinar on assay and system validation hosted by Marian Kelley, contributing author of DeSilva white paper*, on behalf of Gyros® AB.

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Key Topic Updates
June events
EU Regulatory Essentials: Brussels (Belgium)
16th Annual Euro-Biotech Forum (Spain)
Manufacturing sterile products (UK)
Submit your event
 
Latest articles
Taking the modular approach to facility validation
Where have we reached with REACH?
The R&D hurdles for neglected diseases
More latest articles
 
Latest online exclusives
Identifying supplier deficiencies
Cobra's oral vaccination platform
Driving global pharmaceutical security
More online exclusives

Key Topic Updates

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