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IPQ Inside the global regulatory dialogue


Welcome to International Pharmaceutical Quality (IPQ)

 

INTERNATIONAL PHARMACEUTICAL QUALITY provides in-depth coverage of emerging drug, biologic and combination product CMC and GMP issues and developments, with a mission of helping advance and harmonize the quality regulatory process globally. Headquartered in Washington, IPQ is read by regulatory agencies and organizations, suppliers, consultants, law firms, and universities around the world.

IPQ tracks the industry/regulator dialogue at key international forums along with the developments, initiatives, regulations, guidances and standards in the quality regulatory arena to create a uniquely valuable resource for the intelligence gathering, knowledge management, and external communication needs of the pharmaceutical community.

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The News in Depth

IPQ Monthly Update – June 2021 in Review

The four-part IPQ story in this issue explores the current dialogue on the drivers and pathways for a more collaborative, streamlined and globally-minded regulatory approach to combination products in Europe and the activity in progress to reach that goal. In focus in the four parts are: ● the EU Pharma Strategy roadmap, comments from industry, and related agency strategies ● culture/structure/process change and global alignment ● HPRA CEO Lorraine Nolan on HPRA and EMA strategy, and ● EMA’s Zaïde Frias and NB/industry perspectives on EU regulatory transformation.

July 29 2021 / Read More

A Confluence of Forces Is Now Spurring Combination Product Regulatory Reform in Europe

A confluence of forces is intensifying the pressure on and opening pathways to the reform of drug/device combination product regulation in Europe, with legislative changes and strategic priority needs at issue.


Part I: EU Pharma Strategy Roadmap, Comments from Industry, and Related Agency Strategies


Part II: Culture/Structure/Process Change and Global Alignment


Part III: HPRA CEO Lorraine Nolan on HPRA and EMA Strategy


Part IV: EMA’s Zaïde Frias and NB/Industry Perspectives on EU Regulatory Transformation


July 2 2021 / Read More

Pandemic Urgencies Highlight Constraints in Manufacturing Change Regulatory Paradigm and Where Adjustments Are Needed

The pressing need during the COVID-19 pandemic to accelerate product development and rapidly accommodate the shifting manufacturing and distribution demands has shed strong light on the constraints in the existing quality regulatory framework and the pathways to reducing them.

Part I: Industry Quality Leaders on the Global PAC Regulatory Problem and Solutions


Part II: Evolving the Quality Regulatory Paradigm at the Global Level

May 11 2021 / Read More
 

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● “In the News” — breaking stories on our website

● “News Alerts” — sent via email

● “Monthly Updates” — 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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CLICK HERE  for the IPQ Monthly Update – May 2021 in Review


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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IPQ Editor-in-Chief

Paulson_picBefore launching IPQ in 2007, Bill Paulson served for over two decades as the primary author of “The Gold Sheet." During his career, Bill’s reporting and analysis has supported the global regulatory dialogue on advancing and harmonizing CMC and GMP processes for drugs and biologics to keep pace with the evolving technology.

 

Email: [email protected]

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