IPQ Inside the global regulatory dialogue


Welcome to International Pharmaceutical Quality (IPQ)

 

The regulatory paradigm for pharmaceutical quality is undergoing a major transformation.  Keeping up with this transformation is critical to your job and the success of your organization.


International Pharmaceutical Quality places its readers “Inside the Global Regulatory Dialogue”™ where the initiatives that will reshape the landscape are being defined.


Each issue provides an in-depth, cutting-edge report on a key focal point of concern – so readers 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.

 

As an IPQ subscriber you will gain the insight you need into:

  • The critical quality regulatory trends impacting the pharmaceutical industry.
  • What key regulators are thinking and saying about their top concerns.
  • What reviewers are looking for in CMC applications and in interacting with applicants.
  • How to plan for, manage, and respond to regulatory agency inspections.
  • Current investigator focal points and enforcement action triggers.
  • How to design compliant processes and keep them that way.
  • The knowledge needed to make informed decisions and develop effective in-house policies.
  • How to influence the rule-making process and assure that standards are viable.
  • The meaning and purpose behind complex regulations and how to implement them.

Subscribe now and get 12 monthly issues and complete access to the IPQ archives today!

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In the News

QbD is Changing the CMC Regulatory Landscape in the US and EU

The May 2010 issue of International Pharmaceutical Quality (IPQ) provides an in-depth analysis of how quality by design and the new Q8-10 regulatory paradigm is transforming the CMC review process at the agency and international...

May 1 2010 / Comments Off / Read More

Teva and Hospira: Warning Letters, Recalls, and Drug Shortages

Teva and Hospira have both been issued warning letters regarding the manufacture of propofol, and have both issued recalls of propofol, an intravenously administered anasthetic, resulting in a shortage of that drug in the US. ...

April 28 2010 / Comments Off / Read More

MHRA Risk-Based Inspections Require Interim Update Reports

From the MHRA: All sites inspected after 1 April 2009 under risk-based inspection (RBI) should submit interim updates to communicate significant changes between inspections to MHRA. The guidance, instructions, updated report on the RIB effort,...

April 26 2010 / Comments Off / Read More

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IPQ Newsletter 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

 

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”™

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Bill Paulson:
IPQ Editor-in-Chief

Bill Paulson:  Editor-in-Chief

Before launching IPQ in September 2007, 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

Coming in June

An in-depth report on the changing inspection and GMP enforcement landscape in the US, EU, and globally.

©2010 IPQ Publications