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  Pharmaceutical Technology Europe E-Alert
 
25 March 2014
IN THIS ISSUE
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Featured Topics
European Union Packaging Safety Features Come into Effect
Manufacturers are taking measures to comply with new package safety rules. More...
 
Manufacturers Struggle with Breakthrough Drug Development
Accelerated testing and production create challenges in documenting product quality. More...
 
A Survey of Postapproval CMC Changes to Generic Drugs
A survey on postapproval CMC changes were conducted to better understand reporting categories, nature and risks, and review outcomes. More...
 
Drug-Diagnostic Development Stymied by Payer Concerns
The shift to personalized medicine, which supports medical treatment tailored to individual patient characteristics, has been hindered by uncertainty over the value, accuracy, and clinical utility of companion diagnostic tests. More...
 
Top Stories
European Medicines Agency Announces Adaptive Licensing Pilot Project
Looking to improve patient access to new medicines, EMA creates a pilot project to explore an adaptive licensing approach with real medicines in development. More...
 
Pediatric Praziquantel Consortium Receives Grant for the Development of Pediatric Formulations
The Pediatric Praziquantel Consortium has been awarded a research grant from the Japanese Global Health Innovative Technology (GHIT) Fund. More...
 
Novartis Launches Lucentis Prefilled Syringe in Europe
Novartis has launched the prefilled syringe formulation of Lucentis (ranibizumab) in Germany, with other markets to follow throughout 2014. More...
 
Industry News
FDA Approves Eliquis to Reduce the Risk of Blood Clots
FDA approves Eliquis (apixaban) for DVT and PE in patients who have undergone hip or knee replacement surgery. More...
 
Charles River Laboratories to Acquire the CRO Services Division of Galapagos NV
 Charles River Laboratories to acquire CROs Argenta and BioFocus. More...
 
Aesica's High-Capacity Manufacturing Facility in Queenborough Validated for Commercial Production
 Aesica has successfully completed the validation of its high-capacity manufacturing facility in Queenborough, UK, for commercial production. More...
 
Adocia's Combination Insulin Formulation Shows Positive Results in Phase I/II Trial
 Adocia has reported positive results for the first clinical trial of its combination insulin formulation of fast- and long-acting insulin in patients with type I diabetes. More...
 
Webcasts
Avoiding Out-of-Specification (OOS) and Aberrant Results: Weighing and Sample Prep
Wednesday, March 26, 2014 at 11:00 AM EDT
Sponsored by: Mettler Toledo
 
Strategies for Successful Scale-up Using Quality by Design
Thursday March 27, 2014 at 2:00 to 3:00 PM Eastern US Time
Sponsored by: DPT and Confab
 
Navigating the Analytical Development Challenges for Bioprocess Residuals and Impurities
Tuesday, April 1, 2014 at 1:00 PM EDT
Thursday, April 3, 2014 at 15:00 CET

Sponsored by: Eurofins Lancaster Laboratories
 
Increase Control over Quality Management Through Strong Supplier Relationships
Wednesday, April 2, 2014 at 1:00 PM EDT
Sponsored by: Sparta Systems
 
Meeting USP Good Storage and Distribution Practices in a Complex Supply Chain
Thursday, April 3, 2014 at 12:00 EDT (9 AM PDT)
Sponsored by: Vaisala
 
Overcoming Challenges in the Development of Active Drug-Layered Formulations for Multiple Dosage Forms
Tuesday, April 8, 2014 at 11:00 AM EDT
Sponsored by: Patheon
 
More Webcasts

Product Profile
Shimadzu
Nexera X2 – X-ceptional insights
Ultra-high sensitivity, expanded flexibility, increased stability and robustness - the Nexera X2 UHPLC system targets routine analysis and applications in highly regulated environments demanding complex system
setups. Read more
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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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