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          Expanding Generic Drug Access Through International Engagements - 02/28/2024News & Events for Human Drugs Virtual
    Event Title
              Expanding Generic Drug Access Through International Engagements


                  February 28, 2024

  

    
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      Meeting InformationDate:
          
  


     
           

February 28, 2024   

 
 
        
                                      Time: 
                                      
9:00 AM
    - 11:30 AM
ET

 

     Attend
    Register for This Event
  AGENDA

Visit CDER Small Business and Industry Assistance Page

ABOUT THIS WEBINAR

FDA’s Office of Generic Drugs (OGD) ensures, through a scientific and regulatory process, that Americans have access to safe, effective, and high-quality generic drugs. One of the ways OGD supports generic drug regulatory activities is through international engagements.

In this webinar, FDA will discuss and provide updates on FDA and EMA’s Parallel Scientific Advice (PSA) Pilot Program for complex generics/hybrid products, address currently available international engagement opportunities, host a panel discussion on topics pertinent to the generic drug industry, and answer questions during live Q&A sessions with FDA and other global regulatory experts.

INTENDED AUDIENCE

Members of global regulatory agencies including regulatory reviewers
	Generic drug industry including current and prospective applicants who are interested in submitting an application for a generic drug
	Consultants focused on bioequivalence, and clinical research coordinatorsTOPICS COVERED

FDA-EMA Parallel Scientific Advice Pilot Program for Complex Generics/Hybrid Products
	Generic Drug Cluster
	International Collaboration Among Regulatory AgenciesAGENDA

FDA RESOURCES

FDA Office of Generic Drugs Global Generic Drug Affairs
	FDA-EMA Parallel Scientific Advice Pilot Program for Complex Generic/Hybrid ProductsCONTINUING 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:
      01/23/2024
         
                   
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