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Wednesday, June 19 • 10:00am - 11:00am
#318: Defining an Inclusive Clinical Trials Approach in Europe

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-636-L04-P; CME 1.00; RN 1.00

This forum will address industry challenges in the recruitment and retention of underserved populations in clinical research, and explores how regulators, physicians, sponsors and others can work together to develop solutions to tackle health equity.

Learning Objectives

Identify a proposal for addressing underrepresentation of underserved populations in Europe; Describe regulatory and industry perspectives in addressing recruitment and retention challenges for multi-regional clinical trials; Discuss best practices that can help shape inclusivity of clinical trials across borders.

Chair

Ambily Banerjee, PhD

Speaker

ACT-EU Efforts from EMA Perspective
Ana Zanoletty Perez

Evolving FDA Perspective Based on Learningd from DAP Submissions on What Diversity Looks Like
M. Khair ElZarrad, PhD, MPH

Industry Perspective of Community Engagement in Europe: A Case Study
Monique Adams, PhD, MS

CT Network One-Pager v2
Nicholas Brooke, MBA


Speakers
avatar for Ambily Banerjee

Ambily Banerjee

Senior Director/Head of Diversity in Clinical Trials, Johnson and Johnson Innovative Medicine, United Kingdom
After a decade as an academic scientist, following a Ph.D. in Molecular Biology, Ambily moved to GSK Regulatory Affairs, where she held increasingly senior roles in Global Regulatory Affairs and Internal Audit. She also led the race and ethnicity Employee Resource Group, EMBRACE... Read More →
avatar for Monique Adams

Monique Adams

Executive Director, Global Head Diversity and Inclusion in Clinical Trials, Sanofi, United States
Monique Adams is the Executive Director, Global Head of Diversity and Inclusion in Clinical Trials, or DICT, at Sanofi where she drives the pharmaceutical company’s vision, strategy, and implementation of a holistic framework for DICT. Monique has a Ph.D. in Pharmacology from the... Read More →
avatar for Nicholas Brooke

Nicholas Brooke

Executive Director, Patient Focused Medicines Development (PFMD), PFMD, Belgium
Nicholas Brooke is the Founder and Executive Director of The Synergist, an incubator and managing organization to multi-stakeholder platforms that brings key players together with the express aim of solving significant societal problems through collective actions. The Synergist also... Read More →
avatar for M. Khair ElZarrad

M. Khair ElZarrad

Director, Office of Medical Policy, CDER, FDA, United States
Dr. ElZarrad is the Director of the Office of Medical Policy (OMP) at FDA’s Center for Drug Evaluation and Research (CDER), where he leads the development, coordination, and implementation of medical policy programs and strategic initiatives. Dr. ElZarrad currently leads multiple... Read More →
avatar for Ana Zanoletty Perez

Ana Zanoletty Perez

Head of Clinical Trials Transformation workstream, European Medicines Agency, Netherlands
Ana qualified as a pharmacist and following various roles managing clinical trials for the biopharmaceutical industry joined EMA in 2006. At EMA she spent her initial years coordinating initial marketing authorisation procedures, and later transitioned into the management of post-authorisation... Read More →

Wednesday June 19, 2024 10:00am - 11:00am PDT
Room 6F San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  05: Patient-Focused Drug Dev, Forum |   02: ClinTrials -ClinOps, Forum