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X-WR-CALDESC:Events for Global Biodefense
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DTSTART;VALUE=DATE:20221102
DTEND;VALUE=DATE:20221104
DTSTAMP:20220922T163745Z
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SUMMARY:Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting
DESCRIPTION:On November 2\, 2022\, the committee will discuss the Center for Drug Evaluation and Research (CDER) Quality Management Maturity (QMM) program. QMM is the state attained when drug manufacturers have consistent\, reliable\, and robust business processes to achieve quality objectives and promote continual improvement. CDER has proposed the development of a rating system that will help incentivize drug manufacturers to adopt more mature quality management practices at their facilities. The committee will consider the impact that a QMM program would have on the pharmaceutical industry\, drug shortages\, and supply chain resiliency. FDA will seek input to determine if experts from academia and industry support the development of a CDER QMM program to incentivize investments in mature quality management practices. \nOn November 3\, 2022\, as part of CDER’s continued effort to provide key updates on modernization of quality assessment\, the committee will discuss the next stages of Knowledge-Aided Assessment and Structured Application (KASA). The concept of KASA was envisioned in 2016 and discussed at the Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting on September 20\, 2018\, as an IT system that modernizes FDA’s assessment. Through the development\, testing\, and implementation of various KASA prototypes\, the KASA system has been refined over the course of multiple years. FDA will seek input on the vision and plan to expand KASA over the next 5 years to include drug substances\, all generic dosage forms\, new drug and biologics applications\, and post-approval changes. Moreover\, FDA will seek input regarding the need for advancing digitalization in KASA\, including data standardization and mobilization of data from cloud-based servers. \nInterested persons may present data\, information\, or views\, orally or in writing\, on issues pending before the committee. FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2022-N-1777. \nPlease visit the FDA’s Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting Announcement page for more information.
URL:https://globalbiodefense.com/event/pharmaceutical-science-and-clinical-pharmacology-advisory-committee-meeting/
CATEGORIES:Government Hosted,Webinar-Webcast
LOCATION:
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DTSTART;VALUE=DATE:20221114
DTEND;VALUE=DATE:20221117
DTSTAMP:20220922T160410Z
CREATED:20220922T160410Z
LAST-MODIFIED:20220922T160410Z
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SUMMARY:Regulatory Framework for Distributed and Point of Care Pharmaceutical Manufacturing
DESCRIPTION:The FDA and Product Quality Research Institute (PQRI) will host a webcast workshop on the Regulatory Framework for Distributed and Point of Care Pharmaceutical Manufacturing on 14-16 November 2022. \nFuture pharmaceutical manufacturing may occur not only in large manufacturing facilities; it may occur in smaller\, more geographically distributed facilities or even at the point of care. The National Academies of Sciences\, Engineering\, and Medicine noted in a 2021 report that FDA is likely to see substantial innovations in integrated\, flexible\, and distributed manufacturing (DM). These innovations include modular approaches to streamline drug and biologic production and the deployment and use of highly portable manufacturing units that could enable point of care (POC) manufacturing. These types of technologies may challenge the traditional approaches to regulating pharmaceutical manufacturing. \nFDA has also encountered the rapid emergence of advanced manufacturing technologies in various investigational biological products\, such as tissue-based\, cell and gene advanced therapy products\, intersecting with critical areas associated with DM and POC manufacturing. Such biologics are generally more complex with undefined critical quality attributes and often have different manufacturing paradigms. This is particularly true for cellular and gene therapy products and tissue-engineered products. \nThe Workshop aims to facilitate interaction among DM/POC stakeholders on critical areas for development and implementation of these technologies including terminology\, technical challenges to adoption\, operation of Pharmaceutical Quality Systems\, good manufacturing practice expectations\, and the unique challenges and considerations that apply to complex biologics. \nPlease visit PQRI’s Regulatory Framework for Distributed and Point of Care Pharmaceutical Manufacturing website for more information. \n 
URL:https://globalbiodefense.com/event/regulatory-framework-for-distributed-and-point-of-care-pharmaceutical-manufacturing/
CATEGORIES:Webinar-Webcast,Workshop
LOCATION:
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