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Session 9, Track B: Innovative Approaches to Clinical Development Programs and Trial Design
Session Chair(s)
Flavia Firmino Ribeiro, PharmD
Director Reg Global CMC
Pfizer, Brazil
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)
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)
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
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
Head of Clinical FSPx Americas