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.

Daniela Bravo is the Regulatory Policy and Intelligence leader for Latin America at Abbvie. She has a Master and a PhD degree in Health Sciences and previous experiences in regulatory affairs working at the Brazilian Health Authority (Anvisa) and the pharmaceutical industry.

Arthur is an experienced Pharmacist with more than 16 years of experience in Patient Safety & Pharmacovigilance. Currently Country Safety Head Back-Up at Sanofi Brazil. His carreer started at Takeda Brazil, where he acted in roles of increasing responsibility within local/regional/global PV operations organization (including oversight of ICSRs management, PBRER management, RMP management, Audits/Inspections, Pharmacovigilance Agreements, etc). Arthur also worked for CROs (IQVIA (formes Quintiles) and LabCorp (former Covance)), including Local, Regional and Global Projects for Pharmacovigilance and Patient Safety.

Martín Cabrera holds a Bacherlor´s Degree in Public Relations and a Master´s of Art Degree in International Relations. He has served in the public sector for 12 years and his experience in the international regulatory field includes both participation and coordination tasks, as a representative of ANMAT, before harmonization and convergence mechanisms, such as EAMI Network, PAHO/WHO, ICH, PIC/S, ICMRA and IMDRF. Martín´s work has contributed to the analysis and development of various cooperation and collaboration agreements with other health agencies. At ANMAT, he is the Argentine coordination representative before the Committee of Healthcare Products within MERCOSUR regional bloc.

Margarita Contreras Olvera es Licenciada en Relaciones Internacionales por la Universidad del Valle de México, con la Especialidad finalizada en Derecho Sanitario, impartida por la Universidad Autónoma de México, 2022-2023. Desde el 2004, se desempeña en el área internacional de la Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS), en el puesto de Verificador o Dictaminador Especializado A, en la atención de los compromisos internacionales en materia de regulación sanitaria de medicamentos, vacunas y sustancias controladas, mediante la vinculación con agencias sanitarias de otros países, foros y organismos internacionales, así como con las distintas dependencias a nivel federal.

Flavia Firmino is the Global Regulatory Policy Lead for Latin America at Eli Lilly and lead science-based and efficient global regulatory policy initiatives in the region by developing policy positions, assessing, and engaging in external stakeholder groups, and representing Lilly on relevant external work groups with the goal of effecting and leading policy change in the region and beyond. She has a wide range of experience in the strategic and tactical aspects of regional regulatory CMC, including CMC-specific knowledge of requirements in Latin America with a detailed understanding of submission requirements.

Ana Paula Gonçalves is a Pharmacist. She has been working for Bristol Myers Squibb since 2002, based in São Paulo, Brazil. She began her career in regulatory affairs before moving into Pharmacovigilance in 2003. She has a lot of experience in all aspects of pharmacovigilance. She is responsible for managing the Brazil local market pharmacovigilance function and ensures adherence to regulatory requirements, local legislation and to relevant global procedures.

Diana is a physician with an emphasis on public health, a Master’s in Healthcare Business Administration, and a current Medical Law student. She is the Patient Safety Lead for Colombia and PV Policy Lead for Latin America at Roche, where she drives pharmacovigilance, patient safety, and risk management strategies. With over 13 years of experience in the pharmaceutical industry, she has expertise in medical affairs and pharmacovigilance systems. As the leader of FIFARMA’s pharmacovigilance working group and a #SafetyTogether ambassador, Diana promotes PV as a key driver of regulatory harmonization across the region and as a trusted bridge between patients and the PV ecosystem.

Dr Liberti has worked in pharmaceutical regulatory affairs, communications and clinical R&D for the past four decades. From 2009 to 2021 he served as the Executive Director of CIRS. He is the Director of the DK Kim International (USC DRQS) and has been actively involved in promulgating best regulatory practices especially in the emerging markets. He received his doctorate in International Regulatory Policy through the WHO Collaborating Centre for Pharmaceutical Policy and Regulation, Utrecht University, where his research centered on expedited regulatory pathways. He is a volunteer with the nonprofit Erudee Foundation.

Monica is the Global Director of Clinical Quality Management at Merck Chile. A physician with an MBA, Monica brings over 30 years of experience in clinical research. Her career began at the site level, where she managed operations for a Site Management Organization. She later founded her own Contract Research Organization (CRO), expanding its reach to five different countries in Central and South America before selling to Quintiles/IQVIA. While with IQVIA, she developed a partner site network and oversaw site identification operations. In her current role at Merck, Monica is responsible for overseeing early-phase oncology trials, in addition, she is the Business Process Owner for Quality Risk Management within Global Development Operations.

Degree in Pharmacy, Master of Science (pharmacy) UNAM; Diploma in Clinical development and regulatory affairs, Universidad Anahuac; diploma in public health by the Swiss School of Public Health. 32 years of experience in various areas in the Pharmaceutical industry like R&D, quality, manufacturing, regulatory affairs and teaching. She has contributed in: BIRMEX, CDC, USA, Boehringer Ingelheim, Sanofi Pasteur and Novartis where she currently holds the position of Regulatory policy head, LATAM; has collaborated with regulatory authorities and associations of the pharmaceutical industry in the review and preparation of regulatory documents; coordinator of the Regulatory Affairs Committee of the Swiss-Mexican Chamber of commerce.

Current Director of Regulatory Affairs at FIFARMA, the Latin American Federation of the R&D Pharmaceutical Industry. He is responsible for leading regulatory policy and regulatory intelligence for the Federation in the region. Specialist in Pharmaceutical Management and Pharmaceutical Market, holding a master’s degree in Intellectual Property and International Trade, as well as a bachelor’s degree in law. Member of the Steering Committee of the Pan American Network for Drug Regulatory Harmonization (PARF Network), part of the Organizing Committee for the DIA Latin America Annual Conference, and has over 14 years of experience in Regulatory Affairs, Pharmacovigilance, and Regulatory Policy both in Latin America and Globally.

Experienced Global Executive with over 20 years of leading diverse teams in a fast-paced environments in both big and small pharmas. As CEO at Farmacon Global for the past 10 years, a strategic CRO with medical consultants to accelerate clinical research and market access projects in emerging markets, Sara operates with high cultural intelligence and an established record as an expert problem solver to mobilize successful teams for practical results. With their market focus in Rare Disease, Immunology, Infectious Disease, Cancer & Vaccines, Sara, who has lived on four continents and is fluent in Spanish, has a special focus in Latin America, and is growing other key markets around the globe.

Dr. Lina Valero is a multinational leader with over 9 years of experience in the pharma industry. A medical doctor with a focus on Public Health, Master’s in Epidemiology and Business Management. Passionate about Pharmacovigilance, Clinical Research, Medical Engagement, and People Development, Dr. Valero currently serves as PV Head for the LATAM region at Opella Healthcare, formerly part of Sanofi. Her expertise spans clinical trials and post-marketing surveillance across biologicals, general medicines, vaccines, and beyond. As an international speaker in Europe, North America, and LATAM, Dr. Valero is recognized for her strategic, patient-centered approach and her commitment to advancing global collaboration in healthcare.

Cesar serves as Interim EU & International Policy Lead at Accumulus Synergy within Regulatory Innovation. He engages with industry experts, national regulators, and global organizations to foster policy changes and develop strategies that enhance regulatory frameworks, promoting industry collaboration through a cloud-based data exchange model. Cesar supports efforts that permit the adoption of the Accumulus platform by both sponsors and regulators. Additionally, he leads a Topic Group Digitalization in Regulatory for IRISS, pushing forward industry-wide digital advancements. Cesar has over two decades of experience, the last 12 years he spent in Submissions Management leadership roles within Regulatory Operations at Pfizer.