Tag Archive | "ICH"

Can Regulatory Harmonization Be More Effective, and Equitable?

By Paul Thomas, Senior Editor

This month, the not-for-profit Regulatory Harmonization Institute was launched, with the mission of being a regulatory body to better represent the interests of emerging countries and “non-regulatory stakeholders.” (Read RHI’s press release here.) Founding members include BIO, the Generic Pharmaceutical Association (GPhA), and other notable global organizations, as well as representatives of AstraZeneca, Bausch & Lomb, and other major drug and device manufacturers. (See below for profiles of the organization’s leadership.)

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The Regulatory Walls Are Falling Down

By K.R. Karu, Industry Solution Director, Sparta Systems

[Editor's Note: This article originally appeared on the Sparta Systems Blog. Permission to republish has been granted by Sparta Systems.]

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J&J’s Fritschel: An Update on ICH Q11 (Now Available for Public Comment)

By Paul Thomas, Senior Editor

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Hot Off the Press: ISPE’s Guide for Science- and Risk-Based Facilities, Systems, and Equipment

ISPE has published a new guide: “Science and Risk-Based Approach for the Delivery of Facilities, Systems, and Equipment.” According to the publication notes:

“Specific implementation guidance is given on meeting the expectations of global regulators and is compatible with ICH documents (Q8 (R2), Q9, and Q10) and ASTM E2500-07. The Guide will be of interest to those following the latest industry and regulatory initiatives, including:

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An Update on PDA’s PCMO: Getting Technical

By Paul Thomas, Senior Editor

At the PDA Annual Meeting in San Antonio today, Roche’s Stephan Roenninger, PhD, chair of PDA’s Paradigm Change in Manufacturing Operations (PCMO) initiative, provided an update on where PCMO stands roughly a year and a half after its inception.

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Real-Time Release: It’s Time for Action, Not Debate

By Ali Afnan

Like many of you, I follow a number of pharmaceutical industry discussion groups on LinkedIn. Some of these groups have taken on lives of their own, becoming like group blogs. Still, discussions often revolve around one central theme: regulatory reaction and acceptance.

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