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          Integrated Safety Analyses in Drug Marketing Applications: Avoiding Common Mistakes - 03/07/2024News & Events for Human Drugs Virtual
    Event Title
              Integrated Safety Analyses in Drug Marketing Applications: Avoiding Common Mistakes


                  March 7, 2024

  

    
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      Meeting InformationDate:
          
  


     
           

March 7, 2024   

 
 
        
                                      Time: 
                                      
1:00 PM
    - 2:30 PM
ET

 

     Attend
    Register for This Event
  Visit CDER Small Business and Industry Assistance Page

ABOUT THIS WEBINAR

The appropriate planning and conduct of integrated clinical trial safety analyses is critical to the success of drug marketing applications submitted to the FDA. As the safety analytics field is dynamic and evolving, continuous learning is required for the multiple disciplines (medical staff, statisticians, medical writers, etc.) that need to collaborate to create the necessary integrated tables, figures, and analyses.

This webinar will discuss how and when to work with FDA to improve your integrated safety analyses and obtain answers to questions you may have about your application. In addition, common mistakes seen in integrated analyses will be discussed to help you avoid making the same mistakes.

INTENDED AUDIENCE

Pharmaceutical regulatory scientists, clinical reviewers, medical professionals, data scientists, statisticians, statistical programmers, medical writers working on integrated clinical trial safety analyses for new drug marketing applications.
	We will not be discussing trial data for generic drug applications.TOPICS COVERED

Importance of early planning
	Types of issues to discuss at FDA Type C meeting for integrated safety
	How to create integrated analysis sets for safety assessment
	Appropriate analytical and statistical methods when combining clinical trial data from multiple studiesLEARNING OBJECTIVES

Understanding when to contact the FDA for discussion around integrated safety analysis plans.
	Understanding common mistakes in integrated safety analysis.
	Using best practices for integrated safety analysis.FDA SPEAKERS | PANELISTS

***Common Mistakes When Pooling Clinical Trial Safety Data*****Mary Nilsson**
Executive Director-Statistics
Safety Analytics Working Group (FDA|PHUSE)
Eli Lilly

***FDA Type C Meetings on ISS Safety Analysis Strategy and Related Data Requirements*****Veronica Pei, M.D., MPH, MEd**
Associate Director for Biomedical Informatics
DBIRBD | ODES | OND | CDER

PANELIST**Gregory Levin, Ph.D.**
Associate Director for Statistical Science and Policy
Office of Biostatistics (OB)
Office of Translational Sciences (OTS) | CDER

FDA RESOURCES

FINAL FDA Guidance: Meta-Analyses of Randomized Controlled Clinical Trials to Evaluate the Safety of Human Drugs or Biological Products
	DRAFT FDA Guidance: Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA 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 Connectprior 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:
      01/09/2024
         
                   
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