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
          Joint US FDA – Health Canada ICH Public Meeting - 02/24/2023News & Events for Human Drugs Virtual
    Event Title
              Joint US FDA – Health Canada ICH Public Meeting


                  February 24, 2023

  

    
  Share
    Post
    Linkedin

    Email
    PrintOn This Page
      Meeting InformationDate:
          
  


     
           

February 24, 2023   

 
 
        
                                      Time: 
                                      
1:00 PM
    - 4:30 PM
ET

 

  

Topic & Presentations
			SpeakersJoint US FDA – Health Canada ICH Public MeetingOpening Remarks
			**Theresa M Mullin, Ph.D.***Associate Center Director - Strategic Initiatives*
			Center for Drug Evaluation and Research (CDER)
			Food and Drug Administration (FDA)Overview of ICH
			**Nick Orphanos***Senior Policy Analyst*
			Pharmaceutical Drugs Directorate
			Health CanadaBioanalytical Method Validation and Study Sample Analysis
			**Anna Edmison, Ph.D.***Senior Clinical Assessment Officer*
			Division of Biopharmaceutics Evaluation
			Pharmaceutical Drugs Directorate
			Health CanadaClinical Electronic Structured Harmonized Protocol
			**Vivian Combs, M.S.***Senior Director and Process Owner*
			Clinical Foundations
			Lilly Research Laboratories
			Eli Lilly and CompanyDrug Interaction Studies
			**Raj Madabushi, Ph.D.***Associate Director*
			Guidance and Scientific Policy
			Office of Clinical Pharmacology
			Officer of Translational Sciences
			Center for Drug Evaluation and Research (CDER)
			Food and Drug Administration (FDA)Bioequivalence for Immediate-Release Solid Oral Dosage Forms
			**John Gordon, Ph.D.***Senior Clinical Assessment Officer*
			Division of Biopharmaceutics Evaluation
			Bureau of Pharmaceutical Sciences
			Pharmaceutical Drugs Directorate
			Health CanadaA Selective Approach to Safety Data Collection in Specific Late-Stage Pre-Approval or Post-Approval Clinical Trials
			**Mary T. Thanh Hai, M.D.***Deputy Director for Clinical Office of New Drugs*
			Center for Drug Evaluation and Research (CDER)
			Food and Drug Administration (FDA)Rodent Carcinogenicity Studies for Human Pharmaceuticals and Assessment and Control of DNA Reactive (mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk
			**Alisa Vespa, Ph.D.***Senior Scientific Evaluator*
			Therapeutic Products Directorate
			Health CanadaBiodistribution Studies for Gene Therapy Products
			**Sharon Choi, Ph.D.***Senior Scientific Evaluator*
			Biologic and Radiopharmaceutical Drugs Directorate (BRDD)
			Health CanadaViral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
			**Chris Storbeck, Ph.D.***Senior Quality Evaluator*
			Gene Therapies Division
			Center for Biologics Evaluation
			Health CanadaContinuous Manufacturing
			**Sau (Larry) Lee, Ph.D.***Deputy Director of Science*
			Office of Pharmaceutical Quality (OPQ)
			Center for Drug Evaluation and Research (CDER)
			Food and Drug Administration (FDA)Q&A Discussion Panel
			Panelists include above speakers and:

			**Ron Fitzmartin, PhD, MBA***Sr. Informatics Advisor*
			Office of Regulatory Operations (ORO)
			Center for Biologics Evaluation and Research (CBER)

			**Lei Zhang, PhD***Deputy Director*
			Office of Research and Standards (ORS)
			Office of Generic Drugs (OGD) | CDER



Agenda

Visit CDER Small Business and Industry Assistance Page

ABOUT THIS WEBINAR

FDA and Health Canada will be co-hosting a regional public meeting to provide information to stakeholders and solicit input prior to the next ICH biannual Assembly meeting scheduled for June 12-13, 2023.

The public meeting will include presentations by FDA, Health Canada, and PhRMA experts on ICH guidelines recently reaching significant ICH milestones. For example, guidelines recently released for public consultation include a harmonized clinical trial protocol and viral safety evaluation of biotechnology products derived from cell lines of human or animal origin. Recently finalized ICH guidelines include continuous manufacturing and bioanalytical method validation.

TOPICS COVERED

ICH Background
	ICH Guidelines Reaching Key Milestones
	Clinical Electronic Structured Harmonized Protocol
		Drug Interaction Studies
		Bioequivalence for Immediate-Release Solid Oral Dosage Forms
		A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-Approval or Post-Approval Clinical Trials
		Rodent Carcinogenicity Studies for Human Pharmaceuticals
		Assessment and Control of DNA Reactive (mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk
		Biodistribution Studies for Gene Therapy Products
		Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
		Continuous Manufacturing
		Bioanalytical Method ValidationINTENDED AUDIENCE

North American regulators, industry, and other stakeholders interested in learning more about current efforts conducted under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) to develop and harmonize scientifically driven, global standards for safe, effective, and high-quality pharmaceuticals.

FDA RESOURCES

ICH website
	FDA ICH page
	Health Canada ICH page

                                                                                  Content current as of:
      04/21/2023
         
                   
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