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.

Raphael has more than 20 years of experience in Pharmacovigilance, beginning at Sanofi Brazil, where he acted in roles of increasing responsibility within local PV organization, responsibilities including oversight of case management, PSUR management and RMP management. Raphael also worked for Johnson & Johnson as associate manager, with responsibility for 18 countries within Latin America in processes like PSURs, PV Agreements, oversight of reporting to Health Authority and of contracts with vendors and business partners. Also worked at MSD Brazil as Associate Director with experience in PV and Quality & Compliance for PV and Regulatory for Americas. Since Aug.2022 Raphael is Head of PV Brazil at Roche.

Director, 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 since 2019. Committed to improving patient well-being and driving a positive impact on public health.

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.

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.

Susan Koepke is an accomplished Regulatory Affairs professional with more than 25 years of experience in the pharmaceutical industry. With a background in industrial pharmacy and an MBA, she brings a unique blend of expertise to her role at EMD Serono Inc, the healthcare business of Merck KGaA, Darmstadt, Germany. As the Regulatory Affairs Head for Latin America, based in Miami, FL, USA, she spearheads the innovative pipeline delivery and oversees life cycle management activities for established products across the Latin American market. Her wealth of experience and leadership are instrumental in driving regulatory excellence while advocating for best science and evidence-based decision making regulatory framework.

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.

Pharmacist, She is currently Director of Technical Regulatory Affairs and Inovation at Sindusfarma. Specialist in Project Management. She acts in defense of the pharmaceutical industrial sector and coordinates regulatory convergence issues including Pharmacovigilance. She is a member of the Brazilian Pharmacopoeia Management Committee and is responsible for the interface with Anvisa representing associated companies.

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.

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.

Carolina is Regulatory Affairs Director at CAEME (Argentine Chamber of Innovative Medicines) with over 20 years of experience in the pharmaceutical and biopharmaceutical industry, locally and internationally. She is Academic Director of the International Diploma in Regulatory Affairs, member of the Regulatory Affairs Expert Committee of SAFYBI and active in FIFARMA's Regulatory and PV Working Group. She also serves on the Board of AsAF, is a founding member of Pharmacovigilance en español, and represents the Argentine pharmaceutical industry at ICH through IFPMA. Carolina holds degrees in Pharmacy and Biochemistry with a focus in Biotechnology from UBA, as well as national and international postgraduate qualifications in Regulatory Affairs.

Gislaine Capeleti is a licensed pharmacist and seasoned Operations Manager with over two decades of experience in the pharmaceutical industry, specializing in Patient Safety. Currently serving as Operational Manager at PGA Farma, she leads initiatives that support clinical trial and post-marketing safety activities for a diverse portfolio of pharmaceutical companies . Her mission is to help organizations optimize internal processes with high performance and quality, in alignment with regulatory requirements from local and global health authorities. Throughout her career, Gislaine has built a strong reputation for excellence in pharmacovigilance and has expanded her expertise to include medical devices, cosmetovigilance, and nutrivigilance.

Maria Paula offers expert scientific content guidance and project management support for DIA's global consortium initiatives and specialty meetings. She is dedicated to ensuring the development and delivery of impactful, patient-centric scientific content that generates evidence to facilitate 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.

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.

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.

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.

Marcela is the Principal Clinical Site Lead for LATAM at Merck. As a pharmacist with 25 years of diverse experience in the biopharmaceutical industry and contract research organizations (CROs), she specializes in clinical trials and has a strong track record in both global and regional leadership roles. Currently, she oversees and engages in the delivery of operational activities for trials conducted in LATAM within Global Development Operations at Merck. Marcela is deeply passionate about advancing healthcare in the LATAM region, driven by her commitment to improving patient outcomes and ensuring access to innovative treatments.

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.

Pharmacist specialized in drug product regulation with over 23 years of experience in regulatory affairs and product development, acquired both in the private and public sectors. Since September 2023, Marie is the Team Lead for the Facilitated Product Introduction supporting WHO Member States in implementing various reliance facilitated pathways to accelerate introduction of priority medical products in countries. She also works on regulatory convergence and system strengthening activities. Before May 2019, Marie worked 9 years at the European Medicines Agency in London as a Regulatory Affairs Officer and previously in the pharmaceutical industry, contract research organization and consultancies in the United Kingdom, Spain and France.

Dr Alvarado has worked since 2018 at the Uppsala Monitoring Centre (Uppsala, Sweden),which is the World Health Organization-Collaborating Centre responsible for supporting the Program for International Drug Monitoring(WHO-PIDM), his current position is Regional Pharmacovigilance Manager. Dr Alvarado graduated as a medical doctor from the National Autonomous University of Mexico, has a Master´s degree in Public Health with a major in Health Economics and Policy, from the Karolinska Institute(Stockholm, Sweden), and Master´s degree in Pharmacovigilance and Pharmacoepidemiology from the University of Alcalá (Madrid, Spain). Dr Alvarado provides Pharmacovigilance support to Ministries of Health and Regulatory Authorities around the world.

Founder and President of the Association to Help Patients with Primary Immunodeficiency since 2005 due to her eldest daughter's primary immunodeficiency diagnosis. Roberta is also a board member of the International Patient Organisation for Primary Immunodeficiencies since 2007, responsible for the LATAM national members organisations. She is founder and currently Secretary of the Argentine Federation of Rare Diseases since 2024, Vice-chair from 2018 to 2020 and Chair from 2020 to 2024. She is a member of the Ibero-American Alliance for Rare Diseases & Rare Disease International. In 2014 she received an Honorary Diploma in “Recognition of her committed action in the defense of human rights” by the Honorable Senate of the Argentine Nation.

A graduate in medicine from Universidad Autonóma de Madrid, Spain, postgraduate studies in pharmacoepidemiology at Macgill University, Montreal, Canada and in pharmaceutical medicine (combined Strasbourg, Basel and Freiburg universities) Dr Arellano has more than 20 years of experience in the safety and pharmacovigilance (PV) field in the pharmaceutical industry. A senior executive having worked in global roles for top 10 pharma in PV of medicines, consumer products, devices and vaccines Dr Arellano is Global Head of Safety Risk Management at F Hoffmann La Roche, Switzerland. With a career spanning all elements of PV Dr Arellano is committed to excellence in medical compliance and innovation in safety science to create value for society.

Sérgio develops policy and advocacy on complex regulatory issues at IFPMA, with a focus on system strengthening, manufacturing quality, and regulatory reliance. He also played a key role in establishing the Fight the Fakes Alliance, shaping its governance and fostering multi-sectorial collaboration. He brings a creative, solution-oriented perspective to policy development, working across diverse viewpoints to shape pragmatic approaches that strengthen regulatory frameworks. Before joining IFPMA, he worked in late-stage drug formulation and development and as a community pharmacist in Portugal. He holds a Diploma in Management of Clinical Trials from the University of Geneva and a MSc in Pharmaceutical Sciences from the University of Coimbra

Estefania Gerez holds a Bacherlor´s Degree in Biochemistry and Pharmacy with a Master's Degree in Public Administration. She has worked in the public sector (INAME-ANMAT) for 12 years, and her experience in the international regulatory field includes participation and collaboration in regulatory projects and as ANMAT's representative before harmonization and convergence organizations such as PAHO/WHO, IPRRP, and ICH.

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.

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

Over 20+ years of pharmaceutical regulatory affairs expertise including Lifecycle management for regulatory submissions (INDs, NDAs, MAAs, BLAs, DMFs, ANDAs, CTAs) , Regulatory project management across multiple applications and Cross-functional experience in commercial and import/export operations. Key expertise: Technical consulting for global regulatory bodies (FDA, Health Canada, EMA, Swissmedic, Gulf Region, LATAM) • Project leadership: contract/budget management, status analysis, kick-off meetings, submission reports • eCTD consulting and global resource management • Comprehensive project oversight ensuring sponsor-team collaboration within timelines/budgets • Custom business solutions leveraging industry best practices.

Flávia Moreira Cruz is a Pharmacist and Specialist in Health Surveillance and Regulation who has worked at ANVISA since 2005. Her experience spans marketing authorization, traceability/anti-counterfeiting, and package inserts and labeling. Since 2016, she has focused on pharmacovigilance, supporting the national ICSR management system and leading Brazil’s implementation of VigiFlow (VigiMed) in partnership with the Uppsala Monitoring Centre (UMC), while advancing the use of PV databases and analytics. She represents ANVISA in international fora, including the ICH E2B(R3) and ICH E2D(R1) Working Groups, and the CIOMS Working Group XIV on Artificial Intelligence in Pharmacovigilance.

PhD in Medicine (University of Buenos Aires), specialist in Neurology and Clinical Pharmacology. Since 2011, she has worked as a medical evaluator at the Clinical Trials Department of ANMAT. Her main role involves reviewing clinical research protocols in phases I, II, and III, ensuring compliance with national and international Clinical Pharmacology regulations. Her responsibilities include the technical evaluation of study protocols and related documentation, the analysis of efficacy, safety, and quality data. She actively contributes to the ongoing revision of ethical and methodological procedures, as well as continuous training activities. Her work is carried out in coordination with other areas of the agency, such as the Safety and Ef

Julieta Boned is the Patient Safety RMP Manager at Novartis Argentina, where she leads the local implementation and oversight of Risk Management Plans (RMPs). In this role, she ensures alignment with global commitments and regulatory expectations while collaborating with cross-functional teams such as Regulatory Affairs and Global Product Teams. With over a decade of experience in the healthcare and pharmaceutical sectors, including clinical trials and local vigilance, Julieta brings a solid foundation and is committed to contributing to patient safety and continuous improvement through collaborative and pragmatic approaches.

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.

She is pharmaceutical-biochemical graduate from the Faculty of Pharmaceutical Sciences of Araraquara. She has a specialization in Sanitary Surveillance from the School of Public Health at USP and in Sanitary Surveillance in Public Health from FIOCRUZ. In 2005, she completed a Master's in Pharmaceutical Sciences in the area of technological development and quality control of pharmaceutical products by the Federal University of Rio Grande do Sul. She is part of the professional staff of the National Health Surveillance Agency (ANVISA) since March 2000 in the field of medicines, where she worked for two and a half years as a Generic Medicines Manager. Currently works in the Pharmacovigilance area of ANVISA since 2008.

Carmit Strauss PharmD, is an Executive Director at Takeda overseeing the Risk Management, Organ Toxicity and Benefit Risk centers of excellence. She has an extensive experience in risk management working in various leadership roles within Safety, Pharmacovigilance and Medical Affairs. Carmit participants in BR and RM workshops and panels and is a member of CIOMS XII BR on Benefit-Risk Balance for Medicinal Products. Carmit has authored multiple scientific and benefit risk abstracts and publications as well as presented at different benefit risk related conferences on various topics. Carmit obtained her PharmD at the University of Southern California (USC) and holds a Bachelor of Science degree from University of California Los Angeles.

Mrs. Brenda Gomes Valente holds a degree in Pharmacy and a Master’s degree in Microbiology. She has been working at the Brazilian Health Regulatory Agency (ANVISA) since 2005, in the Department of Biological Products Assessment (GPBIO), as a Specialist in Regulation and Health Surveillance. In this role, she has served as a reviewer for marketing authorization applications and post-approval changes of biological products. She has also contributed to the development and revision of regulations and guidelines concerning biological products in Brazil.

Yesica Anastasio is the Coordinator of the International Relations Program at the National Administration of Drugs, Food and Medical Devices (ANMAT). Over the last thirteen years, she has collaborated with institutional development policies and, since 2018, she has been involved in the International Relations field. She is a public relations specialist and holds a Master´s Degree in Organizational Communication Management. Her expertise in the international regulatory arena includes involvement and coordination on behalf of ANMAT in harmonization and convergence mechanisms such as MERCOSUR, Red EAMI, PAHO/WHO, ICH, PIC/S, ICMRA, and IMDRF. Also, she is actively involved in bilateral cooperation with regulatory agencies around the world.

Ana Aymes is a pharma executive with over 30 years of experience in Regulatory, Clinical Research and Development, Medical Writing and Pharmacovigilance. It is through her experiences that she has obtained the skill sets to see data as fields of information and thereby now is the Head of Safety Solutions, Information Management, responsible of the eco-system of tools for Pfizer Worldwide Safety. Since Covid, the need to use technology to accelerate Safety operations has quickly advanced. Ana has led many digital automations in pharmacovigilance with a focus on quality, accuracy and benefits for the patient. It is natural now to be on the edge of AI use in pharmacovigilance, changing the way pharmacovigilance is processed and assessed.

Former intern at the Carolina Foundation of Spain and the U.S. Department of State (IVLP). Curator, specialist in international cultural management, and General Director of Museums of the Ministry of Culture of the City of Buenos Aires until 2012. After receiving the diagnosis of her son with Stargardt (a degenerative retinal disease with no treatment), her professional focus shifted to promoting precision medicine and applied science in health in Latin America and the Caribbean, a leadership activity for which she is internationally recognized. Currently, she is: Director of Projects at ALAPA, the Argentine Alliance of Patients and Founding member of ULAPA, the Latin American Union of Patients with Rare Diseases.

Dr Magda Bujar is Associate Director, Regulatory Programme and Strategic Partnerships and has over 12 years’ experience working in Regulatory Policy and Science. She has co-authored a number of publications and has presented and chaired at major scientific meetings including those of the Drug Information Association (DIA) and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Prior to joining CIRS, Magda carried out research spanning scientific, engineering and policy issues regarding the development of medicines. She received her Master of Science in Biochemical Engineering from University College London (UCL) and a Doctor of Philosophy from the University of Hertfordshire.

Nina S. Cauchon, PhD, leads external engagement and advocacy for RA-CMC at Amgen Inc. She has experience leading both early phase & commercial programs, including small molecules and biologics. Her areas of interest are regulatory harmonization including collaboration, regulatory challenges for innovative modalities and emerging technologies, and science and risk-based approaches to regulations. Nina is active in several external organizations which provide a strong network and knowledge base, including being a speaker/committee member for ISPE (PQLI co-lead), CASSS WCBP (2026 co-chair), AAPS, IQ, and DIA. She is a member of the PhRMA Global Quality and Manufacturing group, and the ICH Q2(R2)/Q14 IWG.

Ana Paula is a pharmacist and a specialist in people management, with over 13 years of experience in Pharmacovigilance at Eli Lilly and AbbVie Brazil. Throughout her career, she has held positions of increasing responsibility and currently serves as Pharmacovigilance Manager and National Qualified Person for Pharmacovigilance at AbbVie Brazil.

Edgar holds a Master's in Pharmacoepidemiology and Pharmacovigilance (PV), specializes in Pharmacotherapy and Clinical Drug Management and Higher Education. He has over 18 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.

Pharmacist graduated in Faculdades Oswaldo Cruz, with a master's degree in Psychobiology from UNIFESP, specialist in Clinical Research from Harvard Medical School. More than ten years working in health consultancy focused on evidence generation, health economics and market access, with 90+ publications in national and international conferences and journals. Currently, working as RWD Partnerhips Senior Director .

Victoria Palmi, Senior International Affairs officer, has over 20 years of experience at the European Medicines Agency (EMA). She supports international collaboration programs and reliance as part of her role in the International Affairs office. Previously, Victoria worked as Product Lead in different therapeutic areas within the Evaluation of Medicines department. During this time, she led initiatives that accelerated assessment and early access to priority medications.

Maria Lineth Perez is a pharmaceutical professional with over 12 years of experience in labeling and pharmacovigilance. She currently serves as International Labeling Team Lead for LATAM at Pfizer, where she drives regulatory compliance, operational excellence, and cross-functional collaboration. She holds a master’s in digital health management, and a specialization in business analytics. With more than four years dedicated to ePI implementation across LATAM, she brings critical expertise in advancing digital labeling solutions that support regulatory agility and patient access to medicinal product information. She has also contributed as a speaker at regional conferences and educational sessions with Health Authorities focused on ePI.

Elkiane is a Health Regulation Expert and currently serves as the Associate Director of the Third Directorate at the Brazilian Health Regulatory Agency (ANVISA). With over 20 years of experience, she has held various roles at ANVISA, beginning as a reviewer and advisor in the Toxicology Office and later in the Biological Products Office. More recently, she has taken on advisory positions within the agency, including in the Directorate, the International Affairs Office, and the General Office of Cosmetics and Sanitizers. Elkiane holds a degree in Pharmacy and Biochemistry with a specialization in the Pharmaceutical Industry, a Master’s degree in Toxicology, and postgraduate certificates in both Toxicology and Health Regulation.

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 position: Head of Clinical Trials Department at Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT), Argentina. Joined ANMAT in 2012 to evaluate Clinical Pharmacology Trials of different pathologies. Since 2018, coordinates the Clinical Trials Department. Graduated as Medical Doctor from the University of Buenos Aires. Pediatrician with a Pediatric clinic residency held at Pedro de Elizalde Children's General Hospital in Buenos Aires. She has a Master in Clinical Pharmacological Research and a specialization in Clinical Pharmacology.

Graduate in Pharmacy and Master in Health Management. I began my work at the Ministry of Health in 2005 in the area of ??Pharmacovigilance. Coordinator of the National Center for Pharmacovigilance and Technovigilance. I have 21 years of professional experience. Since 2008 I was appointed as Coordinator of the National Center for Pharmacovigilance, the governing body in charge of dictating the guidelines for Pharmacovigilance at the national level and since 2014 I have coordinated the National Pharmacovigilance Commission, a technical advisory body for decision-making regarding the safety of medicines in the country. As of 2018 I was appointed coordinator of the National Center for Technovigilance.

Patrice is responsible for shaping and delivering on TransCelerate’ s Health Authority Engagement strategy enabling the overall mission of TransCelerate: to advance collaboration in driving efficient, effective, and high-quality delivery of new medicines through the convergence of clinical care and clinical research. Before joining TransCelerate, Patrice spent 13 years at Johnson and Johnson holding roles in Regulatory including Operations, Policy, and Affairs for both consumer and pharmaceutical products. Prior to J&J, Patrice held various scientific positions at the Nonprescription Drug Manufacturers Association in the US. Patrice has a PhD in pharmacology.

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.

Gabriela Beatriz Bravo is a Biologics Regulatory Reviewer at the Directorate for the Evaluation and Control of Biological and Radiopharmaceutical Products, National Institute of Medicines (INAME), ANMAT, Argentina. She is a member of ANMAT’s Advanced Therapies (ATMP) evaluation group and participates in the ICH Cell and Gene Therapy Discussion Group (CGT-DG), as well as biosimilar working groups. Her expertise covers both pre- and post-authorization quality assessment. She has been working at ANMAT since 2014 and is currently pursuing a master’s degree in Pharmacopolitics

Mrs. Hernández has 11 years of experience at the National Directorate of Medicines, with 7 years in the pharmaceutical product market authorization area and 3 years as the coordinator of the Clinical Research Committee, as well as overseeing the Institutional Journal of Regulatory Sciences, Consciencia Sanitaria. She currently serves as Head of the Clinical Trials Unit (Ad Honorem) and Head of the Operations Office for Registration and Marketing Authorization at the Sanitary Regulation Superintendency. She is responsible for providing technical support for decision-making by the Intendant of Registration and Marketing Authorization, as well as designing, coordinating, and executing plans to improve the efficiency of regulatory processes.

Dr. Carlos Felipe Escobar Roa is the Director of HUB iEX, the Health Innovation and Entrepreneurship Hub at Universidad El Bosque, and leads INNOS, the Health Foresight and Innovation Institute, a joint initiative by AFIDRO and El Bosque. A medical doctor specialized in Otolaryngology and Head and Neck Surgery, with a Master’s in University Management and executive training at Harvard Business School. He has held leadership roles including President and Vice President at El Bosque and has consulted for national ministries and international universities on health and higher education innovation.

Ana is the Head of Department: Quality, Patient Safety, and Accreditation for Hospital Alemán, Buenos Aires. She has a Phd in Biomedical Sciences, Austral University, an MBA from European Business School (EUDE), a Master's in Healthcare Management and Administration from Favaloro University and a Master's Degree in Clinical Pharmacy and Monitoring from University of the Peoples of Europe.

Experienced professional with 14 years of expertise in pharmacovigilance across Latin America, with a career spanning multinational pharmaceutical companies and service providers. Holds a postgraduate degree in Organizational Psychology and People Management, with a strong focus on leadership, team development, and empathetic communication. Skilled in ensuring compliance with both local and global procedures and legislation, overseeing pharmacovigilance and quality systems, and managing audits and inspections. Experienced in delivering training to local teams and across Latin America.

A Registered Pharmacist with deep expertise in global CMC requirements, Erika has a proven track record of developing registration strategies that successfully secure renewal approvals and implementation of post-approval changes for a diverse range of molecules worldwide. Now as a Senior Regulatory Group Director at Roche, Erika leads a team of professionals building and overseeing the end-to-end CMC regulatory strategy for products across more than 120 international markets. Based in Montevideo, Uruguay, she specializes in navigating the complex and often unpredictable regulatory landscapes of Asia, Africa, Eastern Europe, the Middle East, and Latin America.

William Cortez is Pharmacist specialist in Clinical Pharmacy. Graduated from the master's degree in Biotechnology and specialist in Health Regulation who has worked at DIGEMID since 2013. Brings over 10 years of experience in regulation of preclinical and clinical research of medicines. Since 2023, he is head of international affairs of the General Directorate of Medicines, Supplies and Drugs of Peru, and his experience in the international regulatory field includes participation and collaboration in regulatory projects of DIGEMID related to harmonization and regulatory convergence.

Patricia Zuluaga Arias is a Regional Specialist at the Uppsala Monitoring Centre. In her role, she supports the implementation of WHODrug in the region. With over 15 years of experience in pharmacovigilance, patient safety, and the safe use of medicines, she has led academic, regulatory, and clinical projects that have contributed to the development of the discipline in the region. In addition, she has held leadership positions within professional associations and has actively participated in international initiatives aimed at harmonizing standards and fostering collective learning.

Thalita Lima, Ms. Assessor of the Cabinet of the Director President at the Brazilian Bachelor’s degree in Nutrition from the University of Brasilia (UnB), postgraduated degrees in Food Quality and in Regulation and Health Surveillance from the Oswaldo Cruz Foundation (Fiocruz), and Master in Public Administration by Getúlio Vargas Foundation (FGV). Ms Lima has been a government employee at ANVISA for 20 years. During this time, she hold leadership positions such as General Manager at Food Office for 6 years, and Chief Advisor for Better Regulation, for the last 3 years. Recently, in June 2025, she was appointed as assessor of the cabinet of the Director President at the Brazilian Health Regulatory Agency, position she currently hol

Jason Cober is the Director - Regulatory Review, AI, and Digital Transformation at ProPharma Group. He previously led FDA/OPDP's eCTD implementation and has 17 years' experience with the Agency's eCTD specification and guidance development process.

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.

Ms. Andrea Ricchiuti is the at the Head of the Regulatory Inspction Service at the National Institute of Drugs (ANMAT, Argentina). She is a member of the technical Subcommittee of the Argentinean National Pharmacopeia for both active ingredients and final products. She also holds the position of Mercosur Inspector of medicines with a focus on GMP. Ms. Ricchiuti previously held the position of Chief of Service for Drugs Marketing Authorization within the Office of Risk Monitoring and Management. Prior to this role, she served as a Quality Control Analyst, Inspector and Evaluator in the registration and post-registration processes of medicines. Ms. Ricchiuti earned her Bachelor´s degree in Pharmacy from the University of Buenos Aires.

Gabriela Zenhäusern, a pharmacist with a PhD in biomedical research, joined the Stakeholder Engagement Division at Swissmedic, Switzerland in 2019. In her current position, she is leading a team responsible for the coordination of national and international collaboration including development cooperation, acts as Vice-Chair of the Assembly of the International Council of Harmonisation (ICH) and represents Swissmedic at the International Pharmaceutical Regulators Programme (IPRP) Management Committee and the Access Consortium. In addition, she is leading the patient organisation working party at Swissmedic. Gabriela Zenhäusern used to work in the sector authorization at Swissmedic from 2010 to 2015 before joining WHO from 2015 to 2019.

Mariel Peitiado is a pharmacist with 30+ years in the pharmaceutical industry, specializing in clinical trials. She began in regulatory affairs and quality control, later joining Quintiles in 2001 to lead Quality Assurance for Latin America. In 2011, she became Director of Clinical Operations for Argentina, and in 2020, Regional Head of Clinical FSP and GSM at IQVIA. Since 2023, she has served as President of CAOIC, Argentina’s CRO Association.