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          A Joint US-FDA | MHRA-UK | Health Canada Good Clinical Practice & Pharmacovigilance Compliance Symposium - 02/13/2024News & Events for Human Drugs Symposium
    Event Title
              A Joint US-FDA | MHRA-UK | Health Canada Good Clinical Practice & Pharmacovigilance Compliance Symposium


                  February 13 - 15, 2024

  

    
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      Meeting InformationDate:
          
  


     
                                                       
       

February 13 - 15, 2024   

 
 
        
                
                                      Day1: 
              Tue, Feb 13 8:30 AM
 - 3:35 PM
 ET
            
                      Day2: 
              Wed, Feb 14 8:30 AM
 - 3:50 PM
 ET
            
                      Day3: 
              Thu, Feb 15 8:30 AM
 - 4:50 PM
 ET

 

     Attend
    Register for This Event
  **Attend In Person or Online** - Click HERE for Onsite Attendance Information Details

Agenda

Visit CDER Small Business and Industry Assistance Page

ABOUT THIS EVENT

This workshop will focus on Global Clinical Trials in Good Clinical Practice, Bioequivalence, and Pharmacovigilance in the post pandemic world. Presentations and panel discussions will provide information on the recent updates made to ICH E6(r3) and regulatory perspectives on implementation of proportionate and risk-based approaches to the design and conduct of the trial to help ensure that the quality of the trial data generated is of sufficient quality to support good decision making. Panelists will discuss continuing developments in novel operational approaches, data sources, and technologies used in clinicals trials, as well as novel approaches to regulatory inspections.

The event will also include sessions dedicated to the conduct of bioequivalence (BE) studies. Regulators will provide their perspectives on common issues and challenges in the conduct of the clinical and bioanalytical components of BE studies and provide important updates on guidance and inspection activities.

Regulators will also discuss insights into key pharmacovigilance (PV) compliance topics, and the audience will have the opportunity to hear first-hand from regulators about regulatory updates and ongoing collaborative efforts among the international regulatory agencies by conducting and observing inspections, sharing inspection information, and developing policy.

INTENDED AUDIENCE

Researchers and Clinical trial sponsors considering the use of decentralized trial design or Real-World Data
	Organisations sponsoring, conducting, managing or submitting bioequivalence/bioavailability clinical trials for licensing purposes such as the Abbreviated New Drug Application (ANDA) and Biologic License Application (BLA)
	Regulatory Affairs and Clinical Research Quality Management Professionals
	Specialist providers of digital health technologies
	Consultants focused on provision of GCP training, inspection support or quality management
	Foreign and national regulators
	Academic
	Government or private institutions
	Pharmaceutical and biotechnology companies
	Contract Research Organizations/Site Management Organizations
	All those who are involved in the management of clinical trials, including investigators, research coordinators, monitors and consultants.TOPICS COVERED

Key updates to ICH E6(R3)
	The use of technology in clinical trials
	Updates for trials incorporating decentralized clinical trials (DCT) features
	ICH E6R3 data governance updates
	Risk-based approach to sponsor oversight
	Changes in clinical trial activities, inspections, and remote regulatory assessments/ remote inspections
	Policy/guidance updates
	Clinical and bioanalytical challenges in bioequivalence studies
	Updates in guidance, polices, and initiatives by each agencyFDA RESOURCES

Decentralized Clinical Trials for Drugs, Biological Products, and Devices
	Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Q&A (FDA
	M10 Bioanalytical Method Validation and Study Sample Analysis (FDA)
	Postmarketing Adverse Event Reporting Compliance Program (FDA- PhV)
	Good Clinical Practice Resources from Health CanadaCONTINUING 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:
      12/27/2023
         
                   
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