PTSM: Pharmaceutical Technology Sourcing and Management, Mar 2, 2011 - Pharmaceutical Technology

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PTSM: Pharmaceutical Technology Sourcing and Management, Mar 2, 2011
Biologics
The US Biosimilar Regulatory Scheme and Comparison with the European Experience: Where Do Where Go From Here?
By David Rosen , Larry Lian
The authors outline the key decision points FDA must consider in putting forth a US regulatory pathway for biosimilars.
Contract Manufacturing
A Roundup of Informex
By Patricia Van Arnum
Contract manufacturers and fine-chemical suppliers announce capacity expansions and service enhancements of Informex.
Outsourcing
Changes Underway for Biopharmaceutical Outsourcing
By Eric Langer
More crucial biomanufacturing operations are expected to be outsourced.
CSR and Sustainability Forum
Drug Development for Government, Nonprofit, and Developing-World Markets
By Chan Harjivan , George Dougherty
This article is Part I of a three-part series on biopharmaceutical issues in public health, government, and developing-world markets. Part 1 focuses on drug-development. Part II, which examines manufacturing, appeared in the April 2011 of Sourcing and Management. Part III, which analyzes distribution and administration,appeared in the May 2011 issue.
Bristol-Myers Squibb Moves Forward with HIV/AIDS Project in Africa
By Patricia Van Arnum
Bristol-Myers Squibb opens a new pediatric HIV/AIDS clinic in Tanzania.
CSR and Sustainability Forum
A roundup of developments in corporate social responsibility and sustainability from the bio/pharmaceutical industry, its suppliers, and other public and private organizations.

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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
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerTargeting Different Off-Shore Destinations
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAsymmetric Synthesis Continues to Advance
Jill Wechsler Regulatory Watch Jill Wechsler Data Integrity Key to GMP Compliance
Sean Milmo European Regulatory WatchSean MilmoExtending the Scope of Pharmacovigilance Comes at a Price
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