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Session 5: Rethinking MedTech and Regulatory Transparency for Medical Devices in the LATAM Region
Session Chair(s)
Viktoria Magyar, LLM, MSc
Doctoral Student, Department of Regulatory and Quality Sciences
USC Alfred E. Mann School of Pharmacy and Pharmaceutical Sciences, United States
Roberta Mele Mazza, RPh, RAC
Q&RA Manager, División Diagnóstica
Productos Roche , Argentina
The COVID-19 pandemic has put the medical technology (MedTech) industry at center stage with unprecedented demand for diagnostic test kits and other medical equipment, in addition to extraordinary measures underway to accelerate their manufacturing capabilities. Regulatory flexibility, risk-based approach, remote technologies such as, cloud-based monitoring software, telehealth, and virtual site visits, serve the purpose of optimization of clinical outcomes and patient satisfaction. This session will focus on regulatory challenges of the MedTech industry during and following the pandemic, debate ideas to rethinking the public-health response from a regulator and industry perspective, emphasize the growing relevance of AI/ML-enabled medical devices, and highlight pandemic accelerated digital transformation trends.
Learning Objective : - Recognize the regulatory challenges of medical device registration pre before and during the pandemic
- State the impact medical technology innovation has on public health
- Define the meaning of transparency to different stakeholders of AI and ML-enabled medical devices
- List the key affected areas within industry operations by the COVID-19 pandemic
- Describe important areas for future development within the medical device industry
Speaker(s)
What are the Current and Possible Means of Promoting Transparency of AI/ML-Enabled Medical Devices to Users? What are Important Areas for Future Development?
Nathan Allen Carrington, PhD
Roche Diagnostics, United States
Head of Digital Health and Innovation, Global Regulatory Policy and Intelligence
Speaker
Ismary Alfonso Orta, MD, PhD
CECMED, Cayman Islands
Head of Surveillance of Medical Products
Regulatory Mechanisms for Software as a Medical Device and the Use of Digital Pathology During the Pandemic
Brandon D Gallas, PhD
FDA/CDRH/OSEL/DIDSR, United States
Research Mathematical Statician
Regulating During the Pandemic –The Role of FDA’s Latin America Office
Vesa Vuniqi, MS
FDA, United States
International Relations Specialist, Latin America Office
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