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Bethesda North Marriott Hotel and Conference Center

Feb 06, 2023 1:00 PM - Feb 09, 2023 12:35 AM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Global Pharmacovigilance and Risk Management Strategies Conference

Stay current with the latest safety regulations from global health authorities and regulatory experts!

Round Table Discussion Covering Special Topics and Considerations: Can We Have an Inclusive Approach to Clinical Trials and Pharmacovigilance?

Session Chair(s)

Mengchun  Li, MD, MPA

Mengchun Li, MD, MPA

Senior Director, Clinical Research, Infectious Disease

Merck & Co., Inc., United States

Special populations have different safety considerations and are often underrepresented in clinical trials. This leads to challenges with adverse events reporting, safety profile characterization and statistical analysis which ultimately poses challenges in interpretation of data from clinical trials. In this session, we will discuss specific considerations and challenges with regards in rare disease, advanced therapies, and the transgender population. We will also discuss strategies and considerations for reaching the minority population to ensure more representative clinical trials.

Learning Objective :
  • Engage in an active dialogue with experts on special topics in rare disease, advanced therapies, and the transgender population
  • Discuss challenges with reaching the minority population and barriers for enrollment in clinical trials
  • Recognize the need for a more inclusive approach within the drug development lifecycle
  • Identify potential approaches to address safety challenges


Cameron  Zimmermann, MBA


Cameron Zimmermann, MBA

Kite Safety and Pharmacovigilance, United States


Dyan  Bryson


Dyan Bryson

TOTAL Diversity Clinical Trial Management, United States

VP, Diversity Services

Lauren  Shinaberry, MS


Lauren Shinaberry, MS

AbbVie, United States

Director, Clinical Data and Reporting Standards Function

Kevin  Freiert, MBA


Kevin Freiert, MBA

Salem Oaks® Consulting, United States

Owner and Chief Executive Officer

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