Roche's QRM program forged in crisis after Viracept recalled from AIDS epidemic in Africa due to GMP snafu. Upper management promised EU regulators a global review, called QuaSar. Massive effort involved training thousands of workers on how to assess risks and performing 100,000 FMEA risk assessments in just the first year. How Roche addressed the risks identified, replacing machines and even whole facilities when deemed necessary. How Roche transitioned to the proactive post-crisis second phase of its QRM program. The problem with doing FMEAs on Excel spreadsheets.
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
The budget authority total, which is significantly higher than the amount floated in an April OMB draft document, suggests there may have been successful lobbying to increase FDA funding.
In this first in a series of articles looking at the potential impact of the MFN drug pricing policy on European pharmaceutical markets, EUCOPE’s Alexander Natz tells the Pink Sheet why the US policy underscores the importance of confidential net pricing.
The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.
