Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                News & Events for Human Drugs

News & Events for Human Drugs

                        CDER Conversations
          Q&A with FDA
          Spotlight on CDER Science


                        From Our Perspective Home
          Drugs
          News & Events for Human Drugs
          FDA/PQRI Workshop on the Regulatory Framework for Distributed and Point of Care Pharmaceutical Manufacturing: An Opportunity for DM/POC Stakeholder Engagement - 11/14/2022News & Events for Human Drugs Virtual
    Event Title
              FDA/PQRI Workshop on the Regulatory Framework for Distributed and Point of Care Pharmaceutical Manufacturing: An Opportunity for DM/POC Stakeholder Engagement


                  November 14 - 16, 2022

  

    
  Share
    Post
    Linkedin

    Email
    PrintOn This Page
      Meeting InformationDate:
          
  


     
                                                       
       

November 14 - 16, 2022   

 
 
        
                
                          
                          Day1: 
                Mon, Nov 14
              
                          Day2: 
                Tue, Nov 15
              
                          Day3: 
                Wed, Nov 16

 

  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 ETThis 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

                                                                                  Content current as of:
      09/02/2022
         
                   
Regulated Product(s)
		 DrugsMore Meetings,
      Conferences, and
      Workshops
        
        News & Events for Human Drugs

          
                        CDER Conversations
          Q&A with FDA
          Spotlight on CDER Science


                        From Our Perspective
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop