Can Regulatory Harmonization Be More Effective, and Equitable?
A new not-for-profit will champion global regulatory “capacity building,” and aims to correct what it views as failures by the established international regulatory community to address the needs of...
View ArticleIFPAC 2012: The Club Opens Up
If this conference was any indication, maybe more people are starting to see the benefit of modern control, and the three-letter acronyms are taking on new forms, PAT morphing into smarter process...
View ArticleControl, Innovation and the Consumer: Keys to a Different Drug Industry
Ali Afnan: Isn’t it time for pharma to engage, rather than exclude, its key stakeholders?
View ArticleProfitability, Integrity and the Cost of Poor Pharma Quality
Now that emerging pharma markets are tightening their grip on quality, are U.S. manufacturers losing theirs? Bikash Chatterjee explores "COPQ."
View ArticleChanneling Don McLean
To paraphrase a great American folk song, pharma's levee is dry. Nostalgia, or the insistence that “pharma is different,” won't change that, writes Ali Afnan.
View Articlevon Eschenbach: Why FDA Lags Behind
Congress has starved the Agency of funding, he writes, and hampered FDA scientists from fully interacting with peers in industry and academia.
View ArticleCan QbD Get Its Definitions Straight?
After all these years, wonders Emil Ciurczak, why is there still so little agreement on basic terminology?
View ArticleCan Biopharma Avoid the Fate of Small-Molecule Manufacturing?
Ali Afnan asks: Can biopharma act differently and stop thinking so linearly?
View ArticleCutting Through the QbD Foliage, Aiming for the Roots
It is not enough to optimize the existing paradigm of mass production that exists in Pharma, says consultant Hedley Rees.
View ArticleShould QbD Practices Be Patented?
by Agnes Shanley Recently we heard of a very smart PAT/QbD route being patented, but that news only seemed to beg the question of whether giving exclusivity to a few companies would impede further...
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