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Session 5, Track A: Unlocking Precision Therapeutics - Strengthening Regulatory Readiness for Advanced Therapies, Targeted Drugs and Companion Diagnostics
Session Chair(s)
Maria Antonieta Roman
Head Regulatory Policy LaCan, Novartis, Mexico
Priscila De Lara Fagundes Esteves, RPH
Director Regulatory Affairs , PPD Clinical Research Services, Thermo Fisher Scientific, Brazil
This session will explore how advanced therapies, targeted drugs, and companion diagnostics are transforming the therapeutic landscape toward more precise, personalized care. Experts will examine whether regulatory frameworks are keeping pace with these innovations and discuss readiness to evaluate increasingly complex, integrated products. The conversation will also highlight how participation of Latin American sites in clinical development can expand access and contribute to more diverse, globally relevant evidence. Attendees will gain insights into strategies to align innovation, regulatory pathways, and regional inclusion to accelerate patient access to cutting-edge therapies.
Learning Objective : - Assess regulatory readiness for advanced therapies, targeted drugs, and companion diagnostics
- Analyze challenges in aligning regulatory pathways with emerging innovations
- Identify strategies to increase Latin American participation in clinical development
- Explore flexible regulatory approaches for clinical data aligned with global trends
- Identify implementation strategies for reliance models in LatAm
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