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.

With over two decades of experience in regulatory strategy, innovation pipeline, compliance, and digital transformation, she has led regulatory affairs across pharma, biotech, and medical devices in national and multinational companies. She has been instrumental in shaping regulatory policy through active engagement with COFEPRIS and industry working groups at the national level. Previously, she held leadership roles at Merck, Ormco/Danaher, and 3M Mexico.

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.

Pharmacist with fourteen-years experience in pharmaceutical product research, development and manufacturing, and more than ten years of experience in different areas of the NRA of Chile. In 2022, he assumed the head of marketing authorization for biological products at ISP. Since 2023, he has been part of the NITAG of Chile, the “Advisory Committee on Vaccines and Immunization Strategies” (CAVEI), working in the production of different recommendations about immunization to the Ministry of Health in Chile (MINSAL). He is dedicated to regulatory convergence in the Americas Region, promoting reliance in Chile and LATAM region. Leader of the initiative of a joint review of a biosimilar product between different NRAs in the region.

Juan is a Senior Research Analyst at CIRS specialising in regulatory performance benchmarking, regulatory reliance, and regulatory systems strengthening. He leads and contributes to international research evaluating regulatory pathways, review efficiency, and approval outcomes across mature and emerging regulatory authorities. His work includes co-authoring CIRS's annual Six-Agency R&D Briefing and developing evidence-based analyses and metrics to support regulatory policy, reliance implementation, and continuous improvement initiatives. He has worked extensively with regulatory authorities in Latin America, including collaborations on clinical trial and regulatory performance metrics. Prior to joining CIRS, he worked at IQVIA and COFEPRIS

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.

Ms. Pineda joined the U.S. FDA office in Mexico on March, 2013. She has a BSc on Chemistry, Pharmacology and Biology from the UNAM and a MSc on Toxicology from the CINVESTAV/IPN. She started her professional career in the pharmaceutical industry in the production area. In 2001 she joined the Mexican Government as Head of the Toxicology Department at the Ministry of Health, participating in the development of the risk assessment area. For 10 years Ms. Pineda was Manager of International Affairs on Drugs at (COFEPRIS), where she represented and coordinated COFEPRIS’ participation in international fora on drugs, medical devices, dietary supplements, cosmetics, toxic substances and pesticides, as well as developed cooperation agreements.