Specialist in Global Health and Health Regulation, with a Master’s Degree in Development and International Cooperation. Broad experience in regulatory policy, both as regulator in ANVISA and industry, leading or contributing to bilateral and multilateral negotiations, harmonization and convergence initiatives. Specialized knowledge and activities in liaising with government agencies, international and regional organizations, industry and other stakeholders in the area of health regulation. Current role in Roche as Regulatory Policy Lead for Latin America.

Augusto Geyer holds a Pharmacy Degree, a specialization in Sanitary Law, and a Master’s Degree in Materials Science and Engineering. Currently, he serves in the International Affairs Office at ANVISA. He held the position of Head of the Medical Devices Office, where he led strategic initiatives to enhance the regulatory framework for medical devices in Brazil, contributing to the development and implementation of policies to ensure the safety and efficacy of medical devices. Since 2005, he has consistently represented the agency in various international technical working groups and committees. His efforts have been instrumental in aligning Brazil's regulatory practices with global standards and facilitating international cooperation.

Maria Paula offers expert guidance in scientific content development and project management for DIA’s global research partnerships, meetings, and programs. She is dedicated to advancing impactful, patient-centric scientific content that generates evidence to support the integration of innovation in medical product development. She brings experience in public health, patient engagement, and research management. She holds a Master of Science in Health Care Management from Marymount University and a Bachelor of Science in Microbiology and Bioanalysis from Universidad Industrial de Santander, Colombia.

Juan is a Senior Research Analyst at CIRS. With a BSc in Pharmaceutical Sciences, he analyses regulatory policy and performance across major authorities worldwide. He co-authors the annual R&D Briefing on NAS approvals, benchmarking FDA, EMA, PMDA, Health Canada, Swissmedic and the TGA, and turning evidence into guidance for regulators and industry. In the OpERA Programme, he assesses regulatory efficiency, covering timelines, facilitated pathways and the use of reliance, and delivers comparable metrics and practical recommendations to support regulatory strengthening. Previously at IQVIA and COFEPRIS (Mexico), he contributed to projects on market access in Latin America and performance and timely scientific review of MAAs, respectively.

Leonardo Semprún is the Global Science & Regulatory Policy Leader for Latam at MSD, where he leads the definition and execution of regulatory policy plans that address the current and future needs of the region. With over 20 years of experience in the industry, he has held key roles in regulation, quality assurance, intellectual property, and policy, collaborating with governments, regulators, academia, and multilateral organizations to influence regional policy-making. Additionally, he is co-chair of the Regulatory Affairs and Pharmacovigilance group at FIFARMA, where he drives important initiatives in the field of regulation and drug safety.