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Virtual

Mar 06, 2023 10:00 AM - Mar 08, 2023 4:30 PM

(US Eastern Standard Time)

Latin America Annual Meeting

Latin America Annual Meeting is fully virtual. Join us from the comfort of your own space!

Session 9, Track B: Innovative Approaches to Clinical Development Programs and Trial Design

Session Chair(s)

Flavia  Firmino Ribeiro, PharmD

Flavia Firmino Ribeiro, PharmD

Director Reg Global CMC

Pfizer, Brazil

Michelle  Arguelles Gonzalez, MBA, RPh, PMP

Michelle Arguelles Gonzalez, MBA, RPh, PMP

Executive Director, Clinical Research

Merck Sharp & Dohme (MSD), Mexico

This session will examine innovative approaches to clinical development programs and clinical trial design. Speakers will have the opportunity to discuss where we are now and where we are going in relation to clinical trial development and design. Topics such as decentralized clinical trials (DCTs), the use of big data to collect real-world data (RWD) to generate, real-world evidence (RWE), and more, will be evaluated through case studies exploring their acceptance in regulatory decision-making.

Learning Objective :
  • Identify the current state and future of decentralized and hybrid trials
  • Recognize new approaches to field, remote and risk-based monitoring in clinical trials
  • Recognize the necessary tools to increase fit-for-purpose use of RWE and RWD in regulatory decision-making

Speaker(s)

Gabriela  Dávila, MD

A Decentralized Approach for Clinical Trials – Lessons Learned from Previous Experience

Gabriela Dávila, MD

Pfizer Mexico, S.A. De C.V., Mexico

Area Head EUCALA (Europe, Canada & LATAM)

Cintia  Parellada, MD, PhD

Practical Tools to Advance Fit-for-Purpose Use of Big Data to collect Real-World Data (RWD) and Real-World Evidence (RWE) in Regulatory Decision-Making

Cintia Parellada, MD, PhD

MSD, Brazil

Outcomes Research Director - Vaccines

Ricardo  Uribe, MBA

New Approaches to Field, Remote and Risk-Based Monitoring in Clinical Trials

Ricardo Uribe, MBA

Fortrea Clinical Development Mexico, S. De R.L. de C.V., Mexico

Region Head, Clinical Network - Latin America

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