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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

IPQ Monthly Update – January/February 2018 in Review

During January and February, IPQ was focused heavily on the emerging challenges faced by regulators due to the rapidly increasing number of applications encompassing new products and therapies, technologies and processes. The three stories in this issue explore: ● how FDA’s generic drug review process is evolving with user fee support to address the increasing number and complexity of products emerging through it ● how CBER is responding to the wave of advanced therapies it is now facing, and ● a CDER/CBER view of the current biologic product CMC review landscape and the BLA challenges, accomplishments, and learnings.

April 11 2018 / Read More

Opening Panel at CASSS 2018 WCBP Conference Assesses FDA’s 2017 CMC Regulatory Experience with Biotherapeutics and Key Challenges Going Forward

The opening plenary session of the 2018 CASSS Well-Characterized Biotechnology Products (WCBP) Conference, brought together a panel of FDA senior officials engaged in the CMC review process for biological products to assess the 2017 learnings and what the agency and industry needs to do to address the regulatory challenges and stresses going forward.

March 9 2018 / Read More

Expanding Field of Advanced Therapies Puts Pressure on FDA’s Review Staff to Keep Pace

Regulators facing the diversity and complexity of advanced therapies are being challenged with achieving the right balance between providing the regulatory flexibility needed to foster their development and assuring that CMC processes are in place to maximize product safety and avoid the mishaps that could significantly derail their progress.

March 2 2018 / 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.



©2018 IPQ Publications