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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 – September/October 2020 in Review

The impact of the COVID-19 pandemic remained central to IPQ’s coverage during September and October. The three stories in this issue focus on: ● the insights from CBER Director Peter Marks on the difficult terrain that regulators have to navigate with industry to reach the goal of getting effective vaccines and therapies for COVID-19 available as efficiently as possible ● USP’s global collaborative efforts to strengthen the standards and accelerate innovation in the biologics arena, and ● the attention FDA is putting on risk management plans (RMPs) to help in the drug shortage prevention and mitigation part of the pandemic response.

November 24 2020 / Read More

Pandemic Stresses Increase FDA Attention on Risk Management Plans for Drug Shortage Prevention and Mitigation

The stresses of the COVID pandemic on the drug supply chain have thrown a spotlight on the importance of risk management plans (RMPs) in preventing and addressing drug shortages.

November 15 2020 / Read More

USP’s Global Efforts to Strengthen Standards and Accelerate Innovation for Biologics Include ICH Engagement

Direct engagement in the ICH guideline development and revision process is helping USP prioritize its related compendial standard setting, revision, and harmonization efforts, and, in turn, enriching ICH awareness of the pharmacopeial standards and approaches that can help inform its guidelines.

November 9 2020 / Read More
 

Subscription Benefits

SUBSCRIBE TODAY and get 24/7 access to the IPQ family of publications:

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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 – September/October 2020 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]

©2020 IPQ Publications