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IPQ Inside the global regulatory dialogue


Welcome to International Pharmaceutical Quality (IPQ)

 

From breaking news to in-depth analysis, International Pharmaceutical Quality places its readers "Inside the Global Regulatory Dialogue"™ where the initiatives that will reshape the landscape are being defined

IPQ's incisive, cutting-edge analysis allows its readers to understand the forces that are driving the industry/regulator dialogue and the emerging solutions that are being proposed. IPQ provides the context and insight needed to respond to and impact these pivotal quality regulatory trends and developments and make informed decisions.

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The News in Depth

Implementation Challenges for ICH’s New M7 Guideline on Mutagenic Impurities Will Present Themselves at Both the Development and Post-Approval Levels

Among the challenges that will present themselves to pharma companies in implementing ICH’s new M7 guideline on mutagenic impurities is the use of quantitative structure-activity relationship [QSAR] predictions in assessing the risks during development and for post-marketing changes....

October 31 2014 / Read More

CDER’s Office of Pharmaceutical Quality Will Become Functional in January Following Commissioner’s Call for Commodity-Oriented Center/Field Alignment

The initiatives underway at FDA’s Center for Drug Evaluation and Research (CDER) that its new Office of Pharmaceutical Quality (OPQ) will help drive include expertise-based team reviews, closer review/inspection alignment, an auditable quality management system (QMS), a comprehensive pharmaceutical quality IT platform, and new preapproval and surveillance inspection approaches....

October 26 2014 / Read More

Team-Based Quality Assessment Approach Among Key Changes Underway as CDER’s Office of Pharmaceutical Quality Comes to Life

FDA’s Center for Drug Evaluation and Research (CDER) is finding that its new “team-based integrated quality assessment” model makes the review process more efficient and effective, and the model is winning the praise of team members involved....

October 25 2014 / Read More

Updates in Brief

IPQ also provides "Updates in Brief" for its subscribers to alert them to breaking CMC/GMP developments.

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  • “In the News” — breaking stories on our website
  • “Weekly News Alert” — sent via email
  • “Monthly Update” — the key CMC and GMP developments in the US, Europe and internationally
  • “Special Reports” — in-depth analysis of specific, emerging issues of regulator/industry concern
  • Documents and Archives — Live links to all the documents referenced in our stories and full access to IPQ’s valuable archive library

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AugSept TOC pictureClick here for the Aug./Sept. 2014 Monthly Update

 

IPQ’s Mission:

IPQ is dedicated to helping advance the dialogue on evolving and harmonizing the regulation of pharmaceutical and biologic quality and manufacturing.



IPQ takes its readers from:

  • ● the headlines to the forces driving them
  • ● regulations and policies to their underlying intent
  • ● the pieces of the puzzle to their interconnection
  • ● requirements to implementation pathways
  • ● random data to critical trends
  • ● the sidelines to helping shape the outcome
  • ● compliance problems to proactive quality tools
  • ● information to intelligence

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Subscribe today and get 24/7 access to the IPQ family of publications: In the News — breaking stories on our website; Weekly News Alert — sent via email; Monthly Update — the key CMC and GMP developments in the US, Europe and internationally; Special Reports — in-depth analysis of specific, emerging issues of regulator/industry concern; and Documents and Archives — live links to all the documents referenced in our stories and full access to IPQ’s valuable archive library.



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Bill Paulson:
IPQ Editor-in-Chief

Before launching IPQ, Bill served for over two decades as the primary author of “The Gold Sheet.” During his career tracking the drug and biotech quality regulatory process, Bill's identification of key issues and problem areas and emerging solutions has been influential in the targeting of resources by industry and FDA and has impacted the dialogue on the shaping of new CMC and GMP policies. More about About Bill Paulson

 

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