Global Expansion Shapes Drug Oversight; Wockhardt Cited by FDA for QC Failures

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Using Engineered Particles in Capsules for Rapid-to-Clinic Dry Powder Inhalation Applications
Wednesday June 25, 2014 at 11:00 AM EDT
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Best Practices to Overcome Softgel Coating Challenges
Wednesday July 9, 2014 at 11:00 AM EDT
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June 17-19, 2014
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Global Expansion Shapes Drug Oversight
Regulators and industry organizations explain policies and standards to manufacturers and authorities in all regions.

Advances in Controlled-Release Drug Delivery
Industry experts share their perspectives on key advances in controlled-release drug delivery and future innovations in this arena.

Bureaucratic Roadblocks Threaten Biopharma Growth
Protecting intellectual property rights is vital to biopharmaceutical innovation.

EMA Reinstates GMP Certificate for Ranbaxy's Toansa Facility
Despite deficiencies, EMA reinstates GMP certificate for Ranbaxy's Toansa facility, citing no threat to public health.

EMA Changes Guideline on Drug Name Acceptability
EMA publishes revised guideline on the acceptability of names for drugs.

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Life Cycle Management Opportunities in Softgel Technologies
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Wockhardt Cited by FDA for Quality Control Failures
FDA issues a Form 483 to Wockhardt for quality issues at Morton Grove, IL facility.

APIC Publishes New Industry Best Practices Documents
APIC provides guidance on cleaning validation in API plants and how to implement GDP for APIs.

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E-Book: Solid Dosage and Excipients
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Cellectis Enters Agreement With CELLforCURE
Cellectis enters an agreement with CELLforCURE for cGMP clinical manufacturing of allogeneic T-cells.

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Lyophilization Cycle Design and Scale Up – Practical Methodologies for Developing Cycles
Live Webinar: Wednesday, June 11, 2014 at 8:00am PDT/ 10:00am CDT/ 11:00am EDT
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Merck to Acquire Idenix
Merck acquires Idenix Pharmaceuticals for $3.85 billion.

USP Accepts Welcomes New Partners to “Fight the Fakes” Campaign
Eleven new organizations join the global “Fight the Fakes” campaign.

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Best Practices to Overcome Softgel Coating Challenges
Live webcast: Wednesday July 9, 2014 at 11:00 AM EDT
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www.pharmtech.com/coating

Bayer Extends CEO Contract
Bayer extends its CEO contract with Marijn Dekkers until 2016.

Malvern Instruments to Acquire MicroCal
Malvern Instruments will acquire the MicroCal business from GE Healthcare Life Sciences.

Roche Acquires Genia Technologies
Genia's DNA-sequencing platform will strengthen Roche's pipeline.

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Bioprocessing and Sterile Manufacturing
View technical articles on the development and manufacturing of parenteral and biologic drugs, including continuous manufacturing, monitoring, sterilization procedures, modular manufacturing, and more.

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Pharmaceutical Technology presents its Process Analytical Technology resource guide combo
A compilation of informative, useful articles designed to help you meet the challenges of process analytical technology, be more efficient in testing, reduce over-processing, enhance consistency, and minimize rejects. ... Click here

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