International Pharmaceutical Quality targets the issues and challenges surrounding the international harmonization of pharmaceutical and biopharmaceutical regulation and helps further the discussion about the regulatory approaches appropriate for advancing products and processes. Each story provides an in-depth analysis of a key problem area or developing regulatory initiative. IPQ seeks to improve understanding of the issues and aid the development of harmonized global CMC and GMP policies and corporate quality systems.
“The goal of the publication is to delve into and advance the current dialogue between industry and regulators on evolving the paradigm for regulating drug and biotech product quality,” explains IPQ’s Editor-in-Chief Bill Paulson. “IPQ helps its readers understand the changing regulatory environment and be more actively involved in shaping the outcome.”
IPQ staff maintains editorial independence and reports on key conferences and workshops where proposals for industry and regulatory guidance’s and initiatives are being presented. As a driver of the evolving regulatory model and the harmonization effort, the U.S. Food and Drug Administration (FDA) is an important component of IPQ’s coverage. Also included in the publication’s purview are international quality initiatives and harmonization efforts involving the EMA and other regulatory agencies, industry associations, pharmacopeias and standard-setting organizations around the globe.
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- International Pharmaceutical Quality (IPQ) web-based CMC/GMP intelligence service includes our real time “News in Depth” and “Updates in Brief” coverage, “Weekly Alerts” and “Monthly Updates.” Individual subscriptions and licenses include online access to our entire catalog of stories and our text- searchable archives. Subscription/License Information
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