Boyang Wang, Immortal Dragons, explains how FDA’s Expedited IND Pilot and research partners could speed serial steps to first-in-human trials compared to China’s 818 Decree.
|Articles|November 15, 2016
- Pharmaceutical Technology-11-15-2016
- Volume 2016 eBook
- Issue 3
Could Greater Transparency Improve Pharmaceutical Quality and Compliance?
Author(s)Agnes Shanley
Could greater market transparency improve pharmaceutical quality and regulatory compliance?
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A new website and methodology would rank manufacturers based on quality and good manufacturing and business practices. Martin Van Trieste discusses the principles behind medicine-i.com, which he has started up, using software designed by Richard Love, CEO of HarborView.
The site will be driven by algorithms that take quality, compliance and shortages data and rank suppliers based on their level of control in each area.
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Articles in this issue
almost 10 years ago
Extending QMS to Contract Partnersalmost 10 years ago
Too Much by Half: Misapplication of the Half-Cycle Approach to Sterilizationalmost 10 years ago
Investigation Effectiveness Drives Human Performance Excellencealmost 10 years ago
Is Global Regulatory Gridlock Slowing Modernization?almost 10 years ago
Paperless Batch Records for the Massesalmost 10 years ago
Ensuring Quality in Pharmaceutical Raw Materialsalmost 10 years ago
Microbiological Testing: Time is of the EssenceAdvertisement
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Susan J. Schniepp, distinguished fellow with Nelson Labs, and Siegfried Schmitt, PhD, vice president, Technical, with Parexel, clear up some of the confusion about what does and does not need to be complied with regarding standards set by international pharmacopoeias.
Mitigating nitrosamine risk requires assessing each product individually, says Bram Baert, Global Head of Regulatory Affairs at Capsugel, and Sandrine Picco, Senior Analytical Specialist on Capsugel's Innovaform Accelerator Team, in this interview with PharmTech.
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