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 over 19 years in Patient Safety and Pharmacovigilance, currently serving as Patient Safety and Pharmacovigilance Lead at Lilly Brazil. His career began at Takeda Brazil, where he held positions of increasing responsibility within local, regional, and global PV operations, including ICSR, PBRER, and RMP management, audits and inspections, quality, vendor oversight, and PVAs/SDEAs. He also worked for CROs — IQVIA (formerly Quintiles) and LabCorp (formerly Covance) — on global, regional, and local PV projects, followed by a six-year tenure at Sanofi as Patient Safety and Pharmacovigilance Deputy Lead, before joining Eli Lilly Brazil.

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 specializing in public health, holding Master’s degrees in Healthcare Business Administration, Bioethics, and Medical Law. As Roche's Patient Safety Group Lead for Colombia and PV Policy Lead for Latin America, she drives strategic initiatives across pharmacovigilance, patient safety, and risk management. With over 14 years of pharmaceutical industry experience, Diana brings deep expertise in medical affairs, PV systems, and regional policy development. She also chairs FIFARMA’s Pharmacovigilance Working Group and serves as a #SafetyTogether ambassador, dedicated to uniting stakeholders across the pharmacovigilance 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.

Diego serves as Director of Regulatory Affairs & Pharmacovigilance at the Latin American Federation of the Research-Based Pharmaceutical Industry (FIFARMA), where he leads the regional regulatory and public policy agenda for the innovative pharmaceutical industry across Latin America. He holds a Law degree, a specialization in Pharmaceutical Management and Pharmaceutical Marketing, and master's degrees in Registry Law, International Trade, and Public Management and Public Policy. Mr. Salas currently serves as a member of the Steering Committee of the Pan American Network for Drug Regulatory Harmonization (PANDRH/PAHO) and is a Founding Member of the Central American Pharmacovigilance Association (ACENFA).

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.

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.

Mariana Calzada is a Pharmaceutical Chemist and Biologist from UNAM, with an MSc in Medical Sciences focused on clinical research from IPN, a Diploma in Descriptive and Inferential Statistics (UNAM), and an Expert in Pharmacovigilance certification from the University of Alcalá, Spain. With over nine years in pharmacovigilance, her expertise spans ICSR evaluation, signal detection, risk management plans, and regulatory compliance in Mexico. She currently serves as Country Safety Head for Mexico at Opella and is a board member of the Mexican Pharmacovigilance Association (AMFV). Her interests include real-world evidence, risk communication, and pharmacovigilance for consumer healthcare products, including social media monitoring.

Vesa Vuniqi is an International Relations Specialist at the U.S. Food and Drug Administration's Latin America Office, where since May 2021 she has led medical products program activities across the region. She brings extensive regulatory expertise from her previous roles at the Center for Devices and Radiological Health (CDRH), serving as Assistant Director overseeing premarket evaluation and postmarket activities for orthopedic devices, and as a Compliance Officer managing postmarket compliance. Moreover, with over 5 years as an FDA investigator, Ms. Vuniqi combines technical knowledge with regulatory acumen. She holds a Bachelor's in Chemistry and Biological Sciences and a Master's in Biomedical Engineering from Wayne State University.

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.

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.”

Edgar holds a Master's in Pharmacoepidemiology and Pharmacovigilance (PV), specializes in Pharmacotherapy and Clinical Drug Management and Higher Education. He has over 19 years of experience in drug regulation, PV and the promotion of rational drug use. He has contributed to strengthening regulatory and health surveillance processes in the country, with special emphasis on the safety, efficacy and quality of medicines and other human health products. He is Head of the Pharmacovigilance and Other Human Health Products Department at the National Directorate of Pharmacy and Drugs, leading programs and strategies aimed at monitoring drug safety and strengthening the national pharmacovigilance system for the benefit of public health in Panama.

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.

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.

Regulatory Affairs leader with extensive experience in innovative medicines, biologics, and biosimilars across Central America and the Caribbean. Expertise includes regulatory strategy, submissions, lifecycle management, compliance, pharmacovigilance, and regulatory intelligence. Recognized for advancing science-based regulatory frameworks, strengthening regulatory systems, and fostering engagement with health authorities to ensure the quality, safety, and efficacy of medicines. Proven track record in regional leadership, cross-functional project management, and international advocacy on biosimilars, therapeutic innovation, and access to medicines.

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.

Health Regulation Expert with over 12 years of experience in the regulatory evaluation and oversight of non-clinical and clinical development of drugs and biological products. She is currently the Deputy Head of the Clinical Trials Office at Anvisa and a Good Clinical Practice (GCP) inspector. She contributed as Anvisa’s representative to the development of the ICH E17 guideline and currently represents the agency in the ICH working groups for E6 (R3) Annex 2 and ICH E22. She also represents Anvisa in the PAHO Clinical Trials Forum and serves as a full member of Brazil’s National Clinical Research Ethics Commission (INAEP). She holds a degree in Biology and a Master’s in Molecular Biology from the University of Brasília.

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.

João Batista Silva Junior, MHS, has been working at ANVISA, Brazil since 2005 with regulation of blood, tissue, cells and organs for therapeutics uses. He is the manager of the Blood, Tissues, Cells, Organs Office (GSTCO) at the Anvisa/Brazil. GSTCO is responsible for assuring the safety, quality and efficacy of blood, cells, tissues and advanced therapies products and services. Hes is Ph.D student in pharmaceutical and biotechnological sciences, conducting on risk and benefit research in advanced therapy products.

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.

Géraldine Lissalde-Bonnet is the Secretary General of the ICH Secretariat based in Geneva, Switzerland. As Secretary General, Géraldine is responsible for setting and executing the strategic direction and priorities of the ICH Secretariat, for driving internal and external partnerships across the world, ensuring the ICH Secretariat’s agility in responding to the evolving needs of the organisation. Géraldine brings over 20 years’ experience in global health, public affairs and international healthcare supply chain management. Before joining ICH, Géraldine was Vice-President for Healthcare at GS1 Global Office. A lawyer by training, Géraldine started her career in the private sector, complemented by several years in the European Commission

Daniela graduated in Biological Sciences from the University of Brasilia (2002) and completed her PhD in Molecular Biology in the University of Brasilia (2007). Specialization in Health Surveillance by FIOCRUZ, in 2010. Currently, Daniela is the specialist in health surveillance of the National Health Surveillance Agency (Anvisa), with the position of Deputy Director for Director Alex Campos, in the Third Board of Anvisa. She acted as Manager of Biological Products Office at Anvisa from 2014 to 2018.

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.

A published subject-matter expert on genotoxic impurities, Naiffer sits on USP’s Nitrosamine Workstream Committee, contributes to regional regulatory working groups, and is part of the ICH M7 revision working group shaping global guidance on mutagenic impurities. Through active participation in the International Meeting of World Pharmacopoeias and other compendial forums, he continues to advance harmonized, science-driven quality standards while championing open, collaborative, and inclusive dialogue across the nitrosamine field.

Highly experienced international executive with 33 years of experience in the Pharmaceutical Industry. Thirteen years of experience as Regulatory Affairs Director in Mexico and LATAM. Held strategic roles in global companies in the Regulatory Affairs, Pharmacovigilance and Quality fields (Janssen, Boehringer-Ingelheim, Roche, Lundbeck, Mundipharma, Stendhal). Co-founder of the Mexican Pharmacovigilance Association in 2005 and President in 2013-2015.

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.

Helaine Capucho is graduated in Pharmaceutical Sciences, PhD in Science, and specialist in Hospital and Clinical Pharmacy. She was responsible for implementing Patient Safety and pharmacovigilance programs in 40 brazilian federal teaching hospitals. Her publications are focused on hospital pharmacy, pharmacovigilance and patient safety. She is currently an assistant professor at University of Brasilia (UnB) for the Department of Pharmacy of the Health Sciences College, in Brazil, where her teaching and research on pharmacovigilance take place. Moreover, she is a member of the special interest group on medication errors of the ISoP.

Biologist, MSc in Genetics and Molecular Biology, PhD in Epidemiology, with continuous work in health surveillance since 2000 in technical and senior management roles. Former FETP (2004–2006), joined Anvisa in 2005, working in blood, tissues, cells and organs, cell therapy, health inspection, public health emergencies, pesticides, and surveillance of adverse events related to products and medicines. Held management positions including manager of tissues, cells and organs, coordinator of Strategic Health Surveillance Information, and coordinator of pesticide reassessment. From 2023 to 2025, served as General Coordinator of the Center for Strategic Health Surveillance Information currently Manager of Product Monitoring at Anvisa.

Pharmacist with 14+ years of experience in the pharmaceutical industry, specializing in Pharmacovigilance across Latin America and Canada. Currently Sr Director at Pfizer, leading regional safety operations and supporting global services. I hold a Master’s and Business Analytics (Machine Learning & AI). Passionate about team leadership, regulatory compliance, and academic mentorship—having taught at Universidad de Iberoamérica and led collaborative projects with health authorities and international groups.

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.

Katie Jackson is a regulatory policy professional with over twelve years of experience shaping and advancing global biopharmaceutical regulatory policy initiatives across a variety of topic areas. She currently serves as Director, Global Regulatory Policy at Bristol Myers Squibb, where she leads global regulatory policy initiatives across digital health (including AI), cell therapy, and innovative clinical trial approaches. She previously held regulatory policy roles at other pharmaceutical companies and served as a strategic advisor to US FDA as a government contractor. Dr. Jackson holds a Ph.D. from the University of Maryland and has authored multiple peer-reviewed publications.

Carlos Martinez Villela is the Strategic Partnerships Coordinator at Akari Foundation Mexico. He is a Business Management professional, with an NGO Management graduate degree from Universidad de San Andrés, in Buenos Aires, Argentina. He is the former Patient Advocacy and Social Programs Director at an International CRO, and continues his work on Patient Recruitment, Engagement and Retention strategies. He has international experience in Clinical Research, with a special focus on bridging the language and cultural gap in Clinical Research between biotech companies and patient groups in Latin America.

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.

Diogo Penha Soares is Deputy Director at the Brazilian Health Regulatory Agency's Presidency. He joined Anvisa in 2005, having carried out activities related to post-market surveillance, health services regulation and international affairs. Regarding the latter, he was one of Anvisa's representative in the ICH Management Committee and IPRP vice-chair.

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.

Head of the Department of Evaluation and Marketing Authorization of Biological Products at ANMAT, Argentina, and a member of its Advanced Therapies regulatory evaluation team. Since joining ANMAT in 2011, he has specialized in biological medicines regulation. He represents ANMAT in international regulatory harmonization initiatives and is a member of the ICH Q5E Annex Expert Working Group on ATMP comparability and previously served as a member of the ICH Cell and Gene Therapy Discussion Group, contributing to the development of international regulatory standards for advanced therapy medicinal products. He is also Professor of Biochemistry at the Faculty of Medicine of the University of Buenos Aires and the Barceló University.

Attached to the International Affairs Area at the Federal Commission for Protection from Sanitary Risks (COFEPRIS) of Mexico since 2010 Edgardo collaborates in diverse projects aimed to strengthening of Institutional relationship with other global entities of the health sector. He currently performs coordination and monitoring tasks for bilateral initiatives, as well as collaboration in linking strategies up for Medical Devices regulatory convergence.

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.