Subscribe
  
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.

Learn More Subscribe Now

The News in Depth

FDASIA Title VII Implementation Priorities and Action Plans Taking Shape

FDA has been sorting through the multi-faceted supply chain provisions of Title VII of the FDA Safety and Innovation Act (FDASIA) to identify which should be tackled first and to put action plans in place to implement them....

May 11 2013 / Read More

IPQ Monthly Update — April, 2013

The annual conference of the Food and Drug Law Institute (FDLI), held in downtown Washington in mid-April, again provided an important venue for FDA to deliver a “state of the agency” address on the key legal, legislative and regulatory developments during the previous year and what to expect in the year to come....

May 6 2013 / Read More

Search Intensifies for Options to Resource-Draining Redundancies of Multiple Agency Inspections

A road map of previous regulatory inspections and their results is among the ideas being voiced by industry that could help avoid resource-draining inspection redundancy by different agencies and rationalize GMP regulation internationally....

May 2 2013 / Read More

Pharmacy Compounding Will Remain Center Stage as FDA’s Focus Intensifies on Drug Quality, Hamburg Tells FDLI

Pharmacy compounding will remain center stage as FDA’s focus on drug quality continues to intensify, FDA Commissioner Margaret Hamburg told attendees at the 2013 Food and Drug Law Institute (FDLI) Annual Conference in late April in Washington, D.C....

April 26 2013 / Read More

FDASIA Implementation and a Sharpened Focus on Quality Head Center for Drugs’ Agenda

The impact of the Food and Drug Administration Safety and Innovation Act (FDASIA) on the Center for Drug Evaluation and Research (CDER) is beginning to be felt as the center comes to grips with implementing the requirements of the Act and the organizational effort it will take to meet them....

April 25 2013 / Read More

View All News in Depth

Updates in Brief

IPQ also provides "Updates in Brief" for its subscribers to alert them to breaking CMC/GMP developments.

Subscriber Login



Subscription Benefits

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
  • Documents and Archives — Live links to all the documents referenced in our stories and full access to IPQ’s valuable archive library

.

Click to Enlarge

Click here for the April 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

.

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.



SIGN UP for your FREE Weekly "IPQ Alerts" email

Get the latest news on pharmaceutical and biopharmaceutical quality regulation and manufacturing.

  Privacy Policy

Bill Paulson:
IPQ Editor-in-Chief

Bill Paulson: 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

 

IPQ Sponsor Links

©2013 IPQ Publications