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Author Archive

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 | Posted in The News in Depth | Read More »

Regulators Share Pandemic’s CMC Impact at CASSS Japan Forum; Guidance Output Continues Apace in Q1 2021

This four-part story explores the significant impact of the pandemic during 2020-2021 on the CMC review processes for vaccines and biotherapeutics at FDA, EMA and Japan’s PMDA in their efforts to support accelerated product development and review, while assuring that quality standards are met and the ongoing non-COVID-related workload addressed.

Part I: EMA Perspective


Part II: FDA CBER Perspective


Part III: FDA CDER Perspective


Part IV: Panel Discussion Among US, Europe, and Japan Regulators

April 1, 2021 | Posted in The News in Depth | Read More »

Academia/Industry Collaboration Intensifies on Addressing the Pressing Needs in Biopharma Workforce Development

Academia and industry are collaborating more intensely on addressing the pressing needs in biopharma workforce development, in recognition of the challenges of keeping pace with the rapidly evolving process and product technologies and the cross-functional understanding and skills needed to support them.

Part I: NIIMBL’s Engagement with Academia on Workforce Development Needs


Part II: ISPE Workforce of the Future Traction at UMBC and UC Davis


Part III: Keck Institute’s Behrens on Biopharma Talent Needs and KGI/Industry Partnering


Part IV: Xavier’s Phillips on Sharable Quality and Regulatory Science Curriculum


Part V: CASSS Panel on Opening Up Biopharma Career Pathways


Part VI: European and Global Workforce Development Collaborations

March 18, 2021 | Posted in The News in Depth | Read More »

IPQ Monthly Update – July 2019 in Review

September 3, 2019 | Posted in Issue Archive,Monthly Update,Monthly Update | Read More »

IPQ Monthly Update – July 2019 in Review

The first story in IPQ’s Monthly Update for July explores the FDA/CDER efforts to make its quality review process more standardized, transparent, streamlined, IT rich, and knowledge management friendly through its interrelated KASA and PQ/CMC initiatives. The second story explores the attention industry and regulators are now giving to the complex web of issues that come into play in the effective use of preservatives in pharmaceuticals.
September 3, 2019 | Posted in The News in Depth | Read More »

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