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IPQ Inside the global regulatory dialogue

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From Breaking News to In-Depth Analysis — IPQ Keeps You “Inside The Global Regulatory Dialogue”

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, analysis and insight needed to respond to and impact these pivotal quality regulatory trends and developments and make informed decisions.

Your Subscription Benefits:
• “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

“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 will help its readers understand the changing regulatory environment and be more actively involved in shaping the outcome.

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

As an IPQ subscriber you will gain the insight you need into how the changing quality regulatory paradigm is impacting:

  • The CMC review process
  • –  what reviewers want to see in applications and interactions
  • Preapproval and GMP inspections
  • –  what investigators are looking for and finding and how companies manage the process
  • Enforcement actions
  • –  what concerns are drawing follow up and where and how fast action is being taken
  • Process validation
  • –  how the lifecycle paradigm is changing manufacturer practice and investigator expectations
  • Analytical methods
  • –  how QbD is unleashing the power of analytical technology and reshaping the QC lab
  • Regulator/industry communication
  • –  the new linkages being formed and the new roles being defined to implement the advancing quality principles
  • Product/process development
  • –  how the QbD knowledge base is expanding what manufacturers can do and the regulatory flexibility they have to do it
  • Risk management
  • –  how and where RM is being used to improve product quality and control and regulator/industry interactions
  • Quality systems
  • –  how manufacturer and regulator practices are changing as QS thinking is embraced from drug development to supply chain control.
  • Knowledge management
  • –  the challenges industry and regulators face to accommodate the development and on-going improvement of increasingly complex processes and products
  • Supply chain
  • –  how the complexities of global ingredient, manufacturing and distribution networks are driving the search for cooperative solutions
  • Guidelines and standards
  • –  what is being achieved and proposed as the power of industry/regulator cooperation and international harmonization becomes better understood
  • Manufacturing changes
  • –  the strengthening of company quality systems and the clearing of the CMC regulatory pathway to advance technology, continuous improvement and biosimilars

Get all this and more for just $1000 year.

How to Subscribe to IPQ

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