IPQ Inside the global regulatory dialogue

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International Pharmaceutical Quality (IPQ) is a monthly PDF newsletter dedicated to helping advance the dialogue on evolving and harmonizing the regulation of pharmaceutical and biologic quality and manufacturing.

IPQ targets the issues and challenges surrounding regulating a global industry with increasingly complex products and processes. Each issue will provide an in-depth analysis of a key problem area or developing regulatory initiative. IPQ will seek to improve understanding of the issues and to 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 will help its readers understand the changing regulatory environment and be more actively involved in shaping the outcome.

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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

Plus, subscribe today and get 24/7 access to the IPQ newsletter archives online. Access and search our entire content library anytime you need to know the latest “Inside the Global Regulatory Dialogue”TM

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