MD, PhD and Pharmacovigilance specialist with over 20 years of leadership in drug safety, clinical research, and regulatory aligned biomedical innovation. Former Associate Director of Biomedical Research at the National Perinatology Institute, co-founder of institutional research committees. Developed the basis of a Clinical Pharmacology Department at Hospital Juárez de Mexico and served as tenure professor at the public National Polytechnic Institute for 23 years, establishing research quality systems and postgraduate programs. Recognized as member of Mexico’s National Research System (2006–2020), with extensive teaching and expertise in clinical trials, pharmacoepidemiology, and pharmacoeconomics.

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.

Priscila is a pharmacist with over 20 years of experience in regulatory affairs and the CRO industry, with extensive leadership across regional and global regulatory functions. As a Strategic Director supporting biotechnology and biopharmaceutical organizations, she drives regulatory excellence and ensures alignment across diverse clinical development portfolios. Priscila has deep expertise in all phases of clinical trials and in navigating complex global regulatory frameworks across multiple product types and therapeutic areas. She is also a leading expert in Brazilian clinical trial regulations and serves on the Administration Counsel of ABRACRO (Brazilian Association of CROs), actively contributing to regulatory advancement in Brazil.

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.

Master of Science and Pharmaceutical Chemist-Biologist from the Faculty of Chemistry at UNAM (National Autonomous University of Mexico). Visiting professor at public and private Universities on topics such as health regulation, innovation, clinical research, and pharmacovigilance, among others. He has served as Mexico's spokesperson for the Pharmaceutical Group of the Pacific Alliance Business Council and as CANIFARMA's representative at the United States Pharmacopeia Convention. Member of the National Academy of Pharmaceutical Sciences of Mexico. Current Director of Regulatory Affairs and Innovation, coordinating two Technical Commissions at CANIFARMA.

Dr. Cinthya Galicia Quintanar is a Senior Manager Country Safety Lead at Pfizer México, with over 16 years of experience in pharmacovigilance at local and regional levels. She holds a PhD in Medical Research, a Master’s in Health Sciences (Clinical Research), and a degree in Pharmaceutical Chemistry. She has led safety strategy, regulatory compliance, and risk management across multiple organizations. Cinthya is President of the ISoP Latin American Chapter, a recognized opinion leader, professor in specialized diploma programs, and a speaker at national and international conferences.

Ana Paula Gonçalves is a Pharmacist. With over two decades of experience in pharmacovigilance, she leads patient safety initiatives as the Senior Director of Patient Safety Intercontinental at Bristol Myers Squibb. Her work focuses on fostering cross-functional collaborations, promoting cultural adaptation, and ensuring adherence to the highest standards of pharmacovigilance across international operations. Dedicated to advancing global patient safety, she partners with diverse teams to implement strategic initiatives and drive continuous improvement. Her expertise in team leadership and managing safety-related matters enables me to uphold regulatory compliance and support organizational excellence.

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.

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.

Josefina Mendoza serves as Regional DS Lead and Head of PV CAMEX at Grünenthal, leveraging over 23 years of Pharmacovigilance experience. With more than 18 years shaping LATAM drug safety systems—including PV QMS, PV alliance management and regulatory intelligence—she brings deep expertise in GPvP, ICH guidelines, and regional regulations. In the last 5 years, she has also driven global PV projects worldwide. Josefina is recognized for decisive strategic leadership, cross functional influence, and an unwavering commitment to patient safety.

Darinka Ramirez Quiroz is Sr. Director of Pharmacovigilance at MSD Mexico. A Pharmacist (UNAM), she brings 20 years of experience advancing patient safety, risk management, and regulatory compliance across local and Latin American settings. Since joining MSD in 2017, she has led strategic pharmacovigilance initiatives supporting global standards and regional alignment. Darinka is an active member of the Mexican Pharmacovigilance Association and co-founder of the Latin American Pharmacovigilance and Technovigilance Network, contributing to the advancement of PV practices and collaboration across the region.

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.

Dr. Jorge Tanaka Kido is Director of Clinical Research, Asociación Mexicana de Industrias de Investigación Farmacéutica (AMIIF). He has Over 32 years of experience in the Pharmaceutical Industry, having held senior executive positions in areas including Market Access, Public Affairs, Regulatory Affairs, and Medical Direction at companies such as Roche, Novartis, and GlaxoSmithKline. He has an MD from the Universidad Nacional Autónoma de México (UNAM).

Sara Tylosky is a global healthcare executive with over 20 years leading diverse teams across big and small pharma in fast paced environments. As CEO of Farmacon Global for the past 10 years, she leads a strategic network of medical consultants supporting clinical research from pre-IND through market access across the US & Latin America, with a focus on Rare Disease, Immunology, Infectious Disease, Cancer, and Nutraceuticals. Farmacon Global partners with biotechs, CROs, and pharmas as a strategic partner. Sara is an expert problem solver who mobilizes teams for practical results, bringing high cultural intelligence shaped by living on four continents and fluency in Spanish.

Dr. Lina Valero is a multinational leader with extense 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 Vinces is Founder and Principal Advisor at Nuvara, where he advises industry organizations on the evolution of next-generation regulatory operating models, digital transformation, regulatory innovation, AI-enabled regulatory capabilities, and emerging technologies. He has more than 20 years of experience in global regulatory operations, leading global dossier delivery, enterprise transformation, regulatory innovation, and international regulatory collaboration. His current work focuses on the future of regulatory operations and the practical integration of AI and emerging technologies across the regulatory ecosystem.

Director and Pharmacovigilance Lead for the LATAM South Cluster at MSD. Pharmacist and Biochemist from the University of Buenos Aires, Argentina, with over 12 years of experience in Pharmacovigilance. Background includes leading patient safety for South America at Boehringer Ingelheim and earlier roles in PV and Regulatory Affairs at Sanofi Genzyme. Holds a specialization in Drug Regulatory Affairs. Contributing author of the “Manual de Buenas Prácticas de Farmacovigilancia, Ed. Latinoamérica (2018)” and board member of the Argentine Society of Pharmacovigilance (2019–2025). Committed to improving patient well-being and driving a positive impact on public health.

Nikki Chen, PharmD, is a Manager in Global Regulatory Affairs Policy and Strategy at Eli Lilly and Company. She drives development and advancement of regulatory policy and advocacy initiatives across a wide range of multi-portfolio topics impacting global drug development and access. Nikki collaborates with cross-functional teams and external stakeholders, including regulatory authorities and industry associations, to help shape policy positions and drive alignment on evolving regulatory priorities. Her work spans multiple regions where she supports coordinated global engagement and contributes to efforts that inform and influence regulatory frameworks to bring medicines to patients.

Daniella Galarce is a pharmacist and Quality Assurance leader with over 15 years of experience in pharmaceutical regulation, quality systems, and governance across Latin America and Canada. She currently serves as QA Business Partner for the LACan region and Global RLT Quality Launch Lead at Novartis, while supporting Business Development & Licensing (BD&L) initiatives, including M&A activities. Her work includes advancing regulatory innovation and modern quality frameworks, contributing to policy development and the adoption of predictive, risk-based approaches to quality and compliance. She collaborates across regions and functions to support regulatory convergence, quality excellence, and patient access to innovative therapies.

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.

Dr Samvel Azatyan is a paediatrician with a PhD in clinical pharmacology and medical products regulation and more than 35 years of experience in global health. During 26 years with the World Health Organization, he held senior leadership roles in medical products regulation, including regulatory systems strengthening, collaboration, convergence and harmonization, capacity building, product introduction and regulatory reliance. He also played a leading role in organizing the International Conferences of Drug Regulatory Authorities (ICDRAs) and supported national, regional and global regulatory initiatives. Dr Azatyan is currently Deputy Secretary-General of the Council for International Organizations of Medical Sciences (CIOMS) in Geneva.

Dr. Kenneth J. Cavanaugh Jr. has been employed at the U.S. Food and Drug Administration Center for Devices and Radiological Health since 2003 and is currently the Associate Director for International Policy and Strategy. In this role, he oversees the international affairs activities for medical devices and represents the Center on the Management Committee of the International Medical Device Regulators Forum (IMDRF), as co-chair of the IMDRF Good Regulatory Review Practices Working Group, and in multiple international consensus standards development committees. Prior to his current role, he spent over 20 years in FDA’s Office of Cardiovascular Devices as a scientific reviewer, supervisor, and Deputy Office Director.

Eleazar Coba, MSc, is a Pharmacovigilance Officer at Bayer in Mexico with 10 years of experience in pharmacovigilance and patient safety. His professional trajectory combines practical drug safety experience, process quality, and a growing focus on responsible AI, automation, digital tools, and agent-based approaches to improve how safety information is captured, assessed, traced, and used for decision-making in Latin America, while preserving human judgment and accountability. Eleazar is Secretary General of the Mexican Pharmacovigilance Association (AMFV), an active ISoP member, professor in specialized diploma programs, and speaker in national and international forums on digital PV, social media and patient engagement.

Danielle is the Head of the Regulatory Affairs Americas team at the Coalition for Epidemic Preparedness innovations. She studied genomics and molecular genetics at Michigan State University before starting her career in quality and regulatory affairs. Prior to joining CEPI, she worked in the pharmaceutical industry leading regulatory strategies for Phase 1 to Phase 4 programs for medical products, including vaccines, monoclonal antibodies, immunoglobulins and plasma-derived products. In her current role, she partners with vaccine developers and regulators to further CEPI’s mission of accelerating “the development of vaccines against emerging infectious diseases and enable equitable access to these vaccines for people during outbreaks.”

Mike Mayrosh is an Associate Director, Global Regulatory Policy and Strategy for Eli Lilly and Company. Mike leads Lilly's policy work on E-labeling, Artificial Intelligence, Digital Health Technologies, and Clinical Trial Modernization. Mike earned his PharmD from the University of Pittsburgh and served in FDA's Office of Medical Policy prior to joining Eli Lilly.

International Patient Safety Head for Latin America and Canada at Roche with more than twenty years of experience in Pharmacovigilance (PV), including local and regional roles. A pharm D who is driven by the passion and commitment to develop and bring people together across countries and cultures to collectively improve patients' lives. Renata has been advocating the strengthening of the PV system in the region and successfully led the design of the Affiliate Patient Safety model at Roche to sustain our trust with patients and society while proactively addressing unmet patient safety needs. A stronger believer in collaboration with the different sectors of the healthcare ecosystem to significantly improve patients' outcomes.

Carlos Felipe Escobar Roa is Director of Universidad El Bosque’s HUB iEX in Health and leads the Institute for Foresight and Innovation in Health (INNOS), a think tank supporting public policy decision-making and the national dialogue on health and innovation in Colombia and the region. At INNOS, they also lead the Observatory of Good Regulatory Practices (OBPR), which monitors perceptions on adopting international standards for regulating pharmaceutical products. OBPR promotes continuous improvement in regulatory processes for medicines and health technologies, aligned with WHO guidance, including Annex 11. They have broad experience collaborating with public entities, industry, and international organizations to strengthen health systems.

Rodrigo Palacios is an Executive Director in Regulatory Policy at Roche. He is responsible for advancing global policy on data and technology in the regulatory domain. These topics include Cloud Submissions, Data Standardisation (e.g. IDMP), structured data submissions, eCTD and Regulatory Information Management. Rodrigo represents Roche in EFPIA and PhRMA Regulatory Technology expert groups and acts as PhRMA's topic lead in the ICH M16 Expert Working Group. He has over 25 years of experience in data and technology strategy, Information Technology management, software development and consulting.

Accomplished Internal Medicine physician with over 20 years of experience in the pharmaceutical industry, combining clinical expertise with senior leadership in pharmacovigilance, drug safety, and medical affairs. Proven track record in leading complex, multi-country safety activities across Latin America and key European markets, including the UK, France, and Italy, with accountability for benefit-risk oversight, regulatory compliance, and cross-functional safety governance. Held senior roles at Boehringer Ingelheim, Grünenthal, and IQVIA, with more than 10 years of leadership experience in global and regional pharmacovigilance. Expertise in end-to-end signal management, including signal detection, validation, evaluation.

Vada A. Perkins is Vice President. Global Head of Regulatory Policy & Intelligence for Boehringer Ingelheim. He is a former FDA Senior Advisor for Regulatory Science with international regulatory policy and strategy expertise in promoting convergence for the assessment of medicinal products worldwide. He received his degrees from Johns Hopkins University, University of Southern California, and the University of Maryland.