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          Joint US FDA – Health Canada ICH Public Meeting - 02/22/2024News & Events for Human Drugs Virtual
    Event Title
              Joint US FDA – Health Canada ICH Public Meeting


                  February 22, 2024

  

    
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      Meeting InformationDate:
          
  


     
           

February 22, 2024   

 
 
        
                                      Time: 
                                      
11:00 AM
    - 3:00 PM
ET

 

     Attend
    Register for This Event
  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 4-5, 2024.

This public meeting will include presentations by FDA, Health Canada, PhRMA, and BIO experts on ICH guidelines recently reaching significant ICH milestones. Recently finalized ICH guidelines include analytical validation and analytical procedure development and viral safety evaluation of biotechnology products derived from cell lines of human or animal origin. Additional guidelines expected to be released for public consultation in coming months include post-approval safety data management: definitions and standards for expedited reporting and general principles on plan, design, and analysis of pharmacoepidemiological studies that utilize real-world data for safety assessment of medicines.

INTENDED 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.

This event is expected to be of broad interest to industry sponsors including innovator and generic companies.

TOPICS COVERED

ICH Background
	ICH Guidelines Reaching or Approaching Key Milestones
	Q2(R2)/Q14 Revision of Q2(R1) Analytical Validation and Analytical Procedure Development
		Q5(R2) Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
		Q9(R1) Quality Risk Management
		E6(R3) Good Clinical Practice Principles and Annex 1
		M14, General Principles on Plan, Design, and Analysis of Pharmacoepidemiological Studies that Utilize Real-World Data for Safety Assessment of Medicines
		E2D(R1) Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting
		M12 Drug Interaction Studies
	ICH Cell and Gene Therapy Reflection Paper
	Q&AFDA RESOURCES

ICH website
	FDA ICH page
	Health Canada ICH pageCONTINUING EDUCATION

Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations. Certificates are only available during the two weeks post-event.

This course has been pre-approved by:

**RAPS** as eligible for a maximum of 12 credits for a two-day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.
	**SOCRA** who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area.
	**SQA** as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration.
	**ACRP** for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.TECHNICAL INFORMATION

To optimize your webinar experience, use Chrome when viewing Adobe Connect in a browser.
	Please contact info@sbiaevents.com for all technical questions.
	If you encounter any technical issues before or during the event, please visit the Technical Issues Support
	Test your PC for use with Adobe Connect prior to the day of the event. Adobe, the Adobe logo, Acrobat and Acrobat Connect are either registered trademarks or trademarks of Adobe Systems Incorporated in the United States and/or other countries.

                                                                                  Content current as of:
      12/20/2023
         
                   
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