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NH Buenos Aires City

Sep 29, 2025 11:00 AM - Oct 01, 2025 12:00 PM

Bolívar 160, C1066AAD Buenos Aires, Argentina

Latin America Annual Meeting

Take advantage of opportunities for networking and knowledge sharing with key stakeholders influencing the advancement and implementation of initiatives in Latin America and the Caribbean.

Session 4, Track A: Innovative Trial Designs: Accelerating Access Through Smarter Evidence

Session Chair(s)

Diego Alexander Salas, LLM

Diego Alexander Salas, LLM

Regulatory Affairs Director

Federación Latinoamericana de la Industria Farmacéutica, A.C., Mexico

Marcela  Garrot, RPh

Marcela Garrot, RPh

Associate Director, Principal Clinical Site Lead LATAM

Merck Group, Argentina

Innovative clinical trial designs are transforming the way we generate evidence by making studies more adaptive, efficient, and patient-centric. In Latin America, the adoption of methodologies such as platform trials, master protocols, adaptive designs, and decentralized clinical trials (DCTs) is gaining traction—offering opportunities to accelerate access to innovative therapies and strengthen regional research capabilities.

This session will feature a range of perspectives—including regulators, clinical operations experts, and academic leaders—who will present case studies and experiences implementing innovative designs in the region. Topics will include how flexible methodologies have been applied to real-world clinical research in oncology and rare diseases, the evolving regulatory landscape supporting these approaches, and lessons learned in managing operational complexity and ethical oversight.

Attendees will also explore how stakeholder collaboration, digital tools, and infrastructure development are critical enablers for the wider adoption of these models. The session will conclude with a dialogue on how Latin America can enhance its readiness and leadership in the global transition toward smarter, more resilient clinical research frameworks.

Learning Objective :

At the conclusion of this session, participants should be able to:

  • Define core concepts of adaptive, platform, and decentralized clinical trial designs
  • Apply practical examples of these designs to their own regulatory or operational contexts
  • Assess key regulatory and infrastructure needs for implementing innovative methodologies in Latin America
  • Promote stakeholder collaboration to scale up research innovation across the region

Speaker(s)

Marcela  Garrot, RPh

Innovative Trial Designs: Accelerating Access Through Smarter Evidence

Marcela Garrot, RPh

Merck Group, Argentina

Associate Director, Principal Clinical Site Lead LATAM

Laura  Traversi, MD

Speaker

Laura Traversi, MD

ANMAT Ministry of Health, Argentina

Head of Clinical Trials Department

Leonardo  Semprun, PharmD

Speaker

Leonardo Semprun, PharmD

MSD, Panama

Global Regulatory Policy Lead-LatAm

Mariel  Peitiado, PharmD

Speaker

Mariel Peitiado, PharmD

Cámara Argentina de Organizaciones de Investigación Clínica (CAOIC), Argentina

President

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