Posted on 14 December 2011.
The ICH Quality Implementation Working Group has released its final three “Points to Consider” (PtC) documents, following the three it released last June.
As Group member Moheb Nasr pointed out last summer, the PtC documents “are not intended to be new guidelines.” Rather, they are intended to provide further clarity and facilitate regulation in regards to Q8, Q9, and Q10.
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Posted on 07 September 2011.
Dr. Moheb Nasr, one of the architects of the Quality by Design movement within FDA, has decided to leave the Agency and will join GlaxoSmithKline. Nasr has long been an agent of change and champion of new and better pharmaceutical development and manufacturing.
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Posted on 10 August 2011.
By Agnes Shanley
Within the past decade, FDA’s science advisory board meetings on risk management and process analytical technology (PAT) have mirrored the pharmaceutical industry’s vision of drug development and manufacturing and what the “desired space” should be.
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Posted on 24 June 2011.
By Paul Thomas, Senior Editor
This week at DIA 2011, at Chicago’s McCormick Place, Moheb Nasr, director of FDA CDER’s Office of New Drug Quality Assessment (ONDQA) and a key member of the ICH Quality Implementation Working Group, provided an overview of the working group’s recent activities and future goals. The Q-IWG has spearheaded the development and implementation of ICH Q8, Q9, and Q10, and Nasr stated that it has made great progress towards achieving its goals, but outlined current and future challenges as well.
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Posted on 25 February 2011.
by Agnes Shanley
I was waiting for a formal announcement from FDA or EMA, but IPQ publications scooped everyone, by reporting earlier this month on the fact that FDA and EMA will be conducting a pilot program for joint review of the quality-by-design component of new drug marketing applications. (To access their report, with embedded links to relevant articles, including a look at the negotiations leading to this news, click here.)
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Posted on 18 January 2011.
By Emil Ciurczak, Contributing Editor
Today marked the end of the ASTM meetings here in Baltimore and the official beginning of IFPAC 2011. (Here’s a look at yesterday’s festivities.) Today’s ASTM sessions covered the activities of a number of active working groups, addressing such topics as:
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Biotech R&D Demanding New Analytical Techniques, Technologies
An Invitation from PMcG Consulting to Attend the 5th Evening QbD Discussion Group
Teva Changing Their Approaches With Quality by Design
Pharmaceutical “Quality by Design” (QbD): An Introduction, Process Development and Applications
Tech Transfer in the Age of QbD
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