IT: The application of information technology in process development and pharmaceutical manufacturing - Pharmaceutical Technology

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IT
Mobile technology, wireless monitoring systems, RFID. LIMS and electronic notebook systems. Automation, QBAS, & process analytical technology. Service-oriented architecture & integration. Risk management and CAPA.

FDA Perspectives: Common Deficiencies in Abbreviated New Drug Applications: Part 1: Drug Substance

January 2, 2010

Pharmaceutical Technology

Team leaders in FDA's Office of Generic Drugs provide an overview.

eCTD now mandatory for the Centralized Procedure

January 1, 2010

Pharmaceutical Technology Europe

This month sees Europe make its move towards electronic submissions harmonization, but is it ready?

Week of Dec. 28, 2009: Company and People Notes: Ambit Biosciences And Astellas Pharma Form Agreement; Merck Discontinues Development of MK-1903; and More.

December 31, 2009
ePT--the Electronic Newsletter of Pharmaceutical Technology

BioNanomatrix (Philadelphia) names Edward Erickson president and CEO; and More.

Week of Dec. 21, 2009: Company and People Notes: Merck & Co. Acquires Avecia Biologics; Ambrilia Biopharma Closes Manufacturing Facility; And More.

December 23, 2009
ePT--the Electronic Newsletter of Pharmaceutical Technology

Merck & Co. Acquires Avecia Biologics; Ambrilia Biopharma Closes Manufacturing Facility; And More.

Week of Dec. 14, 2009: Company Notes: Sanofi Pasteur recalls H1N1 vaccine; Patheon consolidates Puerto Rico operations.

December 17, 2009
ePT--the Electronic Newsletter of Pharmaceutical Technology

Also, Abbott to acquire Starlims Technologies; GSK Biologicals to form alliance with Intercell.

Process Intelligence Is Critical to the Pharmaceutical Enterprise

December 16, 2009

Equipment and Processing Report

Process intelligence helps users gain a specific understanding of their manufacturing processes and how to control their sources of variability.

Week of Dec. 7, 2009: Company and People Notes: PhRMA adds biopharm members; Dow spins off expression technology; and more.

December 10, 2009
ePT--the Electronic Newsletter of Pharmaceutical Technology

Company and People Notes: Also, Pfizer and Protalix enter agreement; Watson acquires Arrow Group; and more.

Businesses miss out on green opportunities

December 4, 2009

Pharmaceutical Technology Europe

European business leaders are missing opportunities to reduce their environmental footprint and drive efficiencies through document governance, according to research from Ricoh, an electronic solutions provider.

Week of Nov. 30, 2009: Company and People Notes: BASF introduces new tablet-coating system; Catalent achieves ISO 15378 certification; and More.

December 3, 2009
ePT--the Electronic Newsletter of Pharmaceutical Technology

Also, Merck & Co. extends collaboration with Idera Pharmaceuticals; Pfizer establishes R&D center in China; more...

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Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
35%
Breakthrough designations
12%
Protecting the supply chain
35%
Expedited reviews of drug submissions
12%
More stakeholder involvement
6%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
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