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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

Strengthening Biotherapeutic Regulation Worldwide Will Remain a High Priority for WHO in 2017

Strengthening the capacity of governments around the world to regulate biotherapeutics and biosimilars in the effort to increase patient access to high quality products will remain a key priority for the World Health Organization (WHO) in 2017.

February 21 2017 / Read More

IPQ Monthly Update – December 2016 in Review

During December, IPQ explored how the increasing complexity, diversity and importance of drug/biologic/device combination products are driving regulators and industry to seek clearer, more risk-based and more harmonized regulatory processes and expectations. The first story focuses on the situation in Europe, and the second on the industry initiatives underway in the US, Europe and globally to help address the combination product regulatory challenges.

January 31 2017 / Read More

IPQ Monthly Update – October / November 2016 in Review

In October and November, IPQ was focused heavily on the experience and learnings FDA has gained in the first five years of its biosimilars review program and the improvements that the agency and industry want to see happen with user fee help in moving forward. Also in focus in the international section of the Update are: ● advancing and harmonizing other aspects of the biotech product CMC review process, including accelerated pathways, and ● the current pressure and incentives to apply QRM to excipients.

January 23 2017 / 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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Subscription Benefits

Subscribe today and get 24/7 access to the IPQ family of publications:

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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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Front page Nov.Dec. 2015Click here for the November/December 2015 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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