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Top Latin American Officials to Examine Region’s Regulatory Challenges and Opportunities at RAPS Regulatory Convergence

Posted 03 August 2018 | By Zachary Brousseau 

Top Latin American Officials to Examine Region’s Regulatory Challenges and Opportunities at RAPS Regulatory Convergence

RAPS’ upcoming 2018 Regulatory Convergence, to be held 1–4 October in Vancouver, will once again serve as the venue for a high-level discussion of the regulatory challenges and opportunities for introducing innovative medical treatments throughout Latin America. Some of the region’s top regulators, such as Rafael Pérez Cristiá, MD, PhD, director of the Center for State Control of Drugs and Medical Devices (CECMED), part of Cuba’s Ministry of Public Health; and Julio Sánchez y Tépoz, Esq., sanitary promotion commissioner of Mexico’s health regulatory agency, COFEPRIS, will participate in a panel discussion as part of the Latin America Forum on the third day of the Convergence conference, 3 October. See the full agenda here.

In recent years, many Latin American countries have ramped up support for the development of new and innovative therapies to address chronic, debilitating, life-threatening diseases and drugs for unmet medical needs, and regulators and thought leaders have convened at the RAPS Convergence to discuss the latest developments. This year’s expert panel will share insights on how the region’s national authorities are working to change the regulatory paradigm from one focused on administration and control to one that emphasizes speed, innovation and patient access.

“Latin American countries face ever-increasing challenges to guarantee the quality, safety and efficacy of healthcare and related products supporting human health and wellbeing,” said Cuba’s Pérez. “Regulators operating in the healthcare sector are certainly benefitting from greater collaboration to achieve more efficient and intelligent regulatory systems linked to health regulations.”

Rapidly evolving scientific innovation is driving life sciences companies to produce and market new medicines and other healthcare products that are safer and more effective. To help Latin American consumers and healthcare providers leverage these promising new treatments, national authorities are implementing new regulatory approaches like creating facilitated pathways, working closely with other global regulators and granting access to major breakthrough therapies in the early stages of product development. And increasingly, they are communicating more with one another and working together.

Pérez summarized the unique opportunity for open dialogue that RAPS’ annual event affords. “The LATAM Regulators Forum at RAPS 2018 Regulatory Convergence, with active participation from regional national reference agency directors, will share the experiences, initiatives and challenges being faced as they introduce methods directed towards increasing innovation and patient access to medicines through facilitated regulatory pathways,” he said.


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