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  Pharmaceutical Technology Europe E-Alert
 
11 March 2014
IN THIS ISSUE
News
Webcasts
Events
About Us
 
Featured Topics
Track-and-Trace Not Enough to Halt Drug Counterfeiters
Despite legislation to establish a more secure pharmaceutical supply chain in the United States, efforts to block the import of substandard, fraudulent, and counterfeit drugs remains an uphill fight. More...
 
Partnership Models Structure R&D Change
Pharmaceutical companies are adopting multiple choice partnership strategies to meet the challenges of today's R&D instead of being focused primarily on internal development. More...
 
Managing Clinical Development Risk: Pharma and CRO Report
The relatively low success rates for bio/pharmaceutical compounds in clinical development have prompted many organizations to explore ways of reducing risk in clinical development. More...
 
Top Stories
Pfizer Initiates Voluntary Recall of Three Antidepressant Prescriptions
Pfizer initiates nationwide voluntary recall of two lots Effexor XR and one lot Greenstone’s Venlafaxine HCI. More...
 
FDA and EMA Extend QbD Parallel-Assessment Pilot Program
Agencies extend successful pilot program to further harmonization of QbD topics. More...
 
FDA Approves AstraZeneca Once-Weekly, Pen-Injector Diabetes
FDA approves the extended-release Bydureon Pen for the treatment of type 2 diabetes. More...
 
FDA Releases Guidance on CMC Postapproval Changes
New guidance from FDA asks for documentation of CMC post-approval manufacturing changes. More...
 
Novartis Recognizes Rare Disease Day
Novartis calls for more research to understand and find treatments for rare disease. More...
 
INTERPHEX 2014 Preview
Join Pharmaceutical Technology in free educational sessions at INTERPHEX 2014 and hear about the latest advances in biopharmaceutical manufacturing technology. Participate in Q&A sessions to get answers to your manufacturing challenges. Sessions are held on the Innovation Center, Stage 2. Admission to the Innovation Center sessions is free to visitors with an exhibit hall pass. For session details, visit www.pharmtech.com/interphex2014.

Specialty Forum:
The Changing Contract Services Landscape
Presented by Jim Miller, president of PharmSource Information Services
Wednesday, March 19, 9-10 AM

Tuesday, March 18
1:30 pm–2:15 pm: High-Potency Manufacturing for Finished Drugs
2:15 pm–3 pm: Implementing Effective Cleaning Validation Programs.

Wednesday, March 19
10:30 am–11:15 am: The Right Business Decisions In Light of the Drug Quality and Security Act
11:15 am–noon: Getting More Out of the Contract Services Relationship
1:30 pm–2:15 pm: Continuous Manufacturing for Biologic Drugs
2:15 pm–3 pm: Modular Biopharmaceutical Manufacturing Systems.

Industry News
Waters Marks Ten Years of ACQUITY UPLC With the Introduction of New Products
Waters celebrates ten-year anniversary of the ACQUITY UPLC System. More...
 
Cole-Parmer Introduces Digi-Sense Precision Measurement Instruments
Precalibrated instruments deliver accurate readings and withstand rigorous use. More...
 
Schott Introduces Prefillable Polymer Syringe for Infusion Therapy Devices
Schott's 20-mL TopPac prefillable polymer syringe simplifies the infusion-therapy preparation process. More...
 
Beckman Coulter Announces Partnership with Wyatt Technology
Beckman Coulter partners with Wyatt Technology to develop and market products for nanoparticle characterization. More...
 
Impact Analytical Expands Michigan Facility
Impact Analytical’s facility in Michigan adds staff and instrumentation. More...
 
Webcasts
Best Testing Practices for Water Activity: A Risk Assessment Tool for Microbial Limits Testing and Stability Testing
Wednesday, March 12, 2014, 2:00 to 3:00 PM Eastern US
Sponsored by: Decagon Devices
 
Identifying, Analyzing, and Controlling Particles throughout the Biopharmaceutical Product Lifecycle
Tuesday, March 25, 2014 at 11:00 AM EDT
Tuesday, April 1, 2014 at 10:00 to 11:00 CET

Sponsored by: SGS Life Science Services
 
Avoiding Out-of-Specification (OOS) and Aberrant Results: Weighing and Sample Prep
Wednesday, March 26, 2014, 11:00 AM EDT
Sponsored by: Mettler Toledo
 
Strategies for Successful Scale-up Using Quality by Design
Thursday March 27 at 2:00 to 3:00 PM Eastern US Time
Sponsored by: DPT and Confab
 
More Webcasts

Product Profile
ETQ
Risk Management's Impact on QMS
Risk Management is everywhere, and is not some lofty strategic element that is limited to top floor suits making enterprise-wide decisions. Risk is just another tool in the quiver of the compliance process; it is a method for streamlining your business, like any other compliance process. Read more

Survey

Are you involved with pharmaceutical production equipment for finished drug products? Please participate in our annual survey on key trends in equipment and manufacturing.


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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