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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

CBER Advice on CGT Process and Facility Management Includes Early Consideration of Engineering and Capacity Needs

As its experience grows with reviewing cell and gene therapy (CGT) processes, equipment and facilities, CBER is strongly recommending that firms start early in thinking about the engineering and capacity needs of a commercial facility.

October 11 2019 / Read More

IPQ Monthly Update – August 2019 in Review

The three stories in the Monthly Update for August explore facets of the intense discussions that are now taking place at industry/regulator forums on the CMC challenges that need to be faced en route to realizing the promise of cell and gene therapies. In focus are: ● the dialogue at the NIIMBL annual meeting on these challenges and the industry/agency/academia collaboration needed to meet them, and ● an exploration by CBER and industry experts on the added CMC pressures created for CGTs by accelerated development and review timelines and how these pressures can be dealt with.

October 7 2019 / Read More

Preparing for CMC Changes is Difficult but Pivotal to Accelerating CGT Development, Industry Experts Are Stressing

Cell and gene therapy (CGT) sponsors are wrestling hard with how to prepare for having to make CMC changes throughout the development, submission, and post-approval stages, while facing accelerated timeframes and significant knowledge limitations.

October 2 2019 / Read More
 

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

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● “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 – July 2019 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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Bill Paulson:
IPQ Editor-in-Chief

Paulson_picBefore launching IPQ in 2007, Bill 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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