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About Workshop:

FDA and PQRI are excited to announce they will host an FDA/PQRI Workshop on the Regulatory Framework for Distributed and Point of Care Pharmaceutical Manufacturing on November 14 – 16, 2022, as a virtual event.

This FDA/PQRI Workshop will bring together leaders from regulatory agencies, industry, and academia to discuss critical topics in distributed manufacturing and point of care manufacturing.

Future 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.

FDA 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.

Workshop Objectives:

The Workshop aims to facilitate interaction among DM/POC stakeholders on critical areas for development and implementation of DM and POC 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.

Meeting Information & Registration:

Date: November 14 – 16, 2022

• Day 1: Mon, Nov 14th 10:00 AM – 3:00 PM ET
• Day 2: Tues, Nov 15th 10:00 AM – 3:00 PM ET
• Day 3: Wed, Nov 16th 10:00 AM – 4:00 PM ET

This virtual workshop is open to anyone interested in DM/POC, specifically to learn from experts and contribute ideas. Click here to register.

Visit the Workshop website for more information.

For questions regarding this event contact PQRI Secretariat Dede Godstrey