Marta Avellar, Medical Information Head for Latin America and Canada, at Takeda, brings 25 years of experience in the Pharmaceutical Industry. She has held leadership positions in Pharmacovigilance at Wyeth (now Pfizer), Janssen, and Shire (now Takeda) in Latin America. Marta spearheaded the implementation of Medical Information operations in the region and played a crucial role in integrating Medical Information after global mergers and acquisitions. Her passion lies in innovation, effective communication, and process excellence.

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.

Raphael has more than 17 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.

Flavia Firmino is Director in the Global CMC (Chemistry, Manufacturing & Controls) at Pfizer, with the role of Regulatory Advisor for Latin America and Africa/Middle East. She is based in Brazil and has over 20 years of experience in pharmaceutical industry in Quality and Regulatory areas and held leadership positions in Regulatory Conformance, Quality Operations and Regulatory Affairs. In her current role, she provides guidance and direction to project teams to mitigate regulatory risk and integrate CMC policy with product strategies, while developing and advocating policy positions on draft regulations in region and external engagement on CMC topics.

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.

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 has served as the Executive Director of CIRS (the Centre for Innovation in Regulatory Science, Ltd, forming part of Clarivate Analytics). He has been actively involved in promulgating best practices in the regulatory aspects of medicines development, 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 with applicability in the emerging markets. He is a volunteer with the nonprofit Erudee Foundation.

Mercedes is originally from Mexico and holds a bachelor’s degree in economics, a master’s degree in Inter-American studies and PhD work in Latin American Culture and Education and PhD work in Organizational Leadership studies. Mercedes has trained and presented compelling information to National Cancer Institute directors throughout Latin America and influenced their participation in clinical research. Now, as a Regional Operations Manager for Latin America, Mercedes is focused on the development of Clinical Research professionals in Latin America and is confident in her capacity to convocate and connect with people of different cultures and interests to continue growing the network of clinical research sites and CRCs.

Elkiane is a Health Regulation Expert of the Brazilian Health Regulatory Agency - ANVISA. With 19 years of experience, she has served as a reviewer and advisor at ANVISA, initially in the Toxicology Office, and subsequently in the Biological Products Office. Recently, she has assumed advisory roles within ANVISA, first within the Directorate and presently in the International Affairs Office. She has been a member of ICH Q12 Expert Working Group and currently o currently serves on ICH Q6 as a Rapporteur Supporter. She holds a Pharmacy and Biochemistry Degree with specialty in Pharmaceutical Industry, a Master’s degree in Toxicology, Postgraduate certificates in Toxicology, and in Health Regulation.

Over 15 years of experience in law, finance, and corporate compliance. Worked for numerous small and mid-sized law firms, renewable energy companies, before launching MGC Associates LLC, a fully integrated pharmaceutical and medical device consulting partnership. Current area of focus and specialty is regulatory and quality sciences pertaining to medical devices, in vitro diagnostics, and digital health technologies in Latin American and Caribbean regions. She is currently working towards her Doctorate in Regulatory Sciences (DRSc) at USC.

Pharmacist, She is currently Director of Technical Regulatory Affairs and Inovation at Sindusfarma. She has worked for 17 years in the pharmaceutical industry. 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.

Barbara is a PharmD and holds a B.S. in Marketing and Business Management, with 18+ years’ experience in the pharmaceutical industry supporting businesses with technical and medical expertise. Barbara has worked in several areas (Medical, Pharmacovigilance, Quality, Compliance, Customer Service and Marketing) in different industries such as Sanofi, Sanofi Pasteur, Biogen and Local Brazilian CRO. Barbara joined PPD in June 2017 and is currently a Director of Operations, working with different global clients, including Latin America, US, Europe and APAC.

Patricia Oliveira Pereira Tagliari holds a master’s degree in Public Health (Global Health and Health Diplomacy) from the National School of Public Health (2014), specializations in Health Regulation and Surveillance (2010) and Health Law (2007), both from Fiocruz, and a degree in International Affairs from the University of Brasilia (2004). She is currently a government employee, specialist in health regulation and surveillance, at the Brazilian Health Regulatory Agency - Anvisa. From April 2020 to the present date, Ms. Tagliari has served as Associate Director at Anvisa. Prior to that, she served as Advisor at Anvisa’s Office of Inspection and Health Surveillance and as the Head of Anvisa's International Affairs Office.

Professional in Pharmaceutical Sciences with 20 years of experience, 15 of them in the sector of health regulation of medicines; focused mainly on the management of international cooperation from National Regulatory Authorities, networking, project management, negotiation and implementation of agreements, construction and monitoring of action plans, intellectual property and its linkage with access to medicines and other health technologies and the preparation and publication of scientific publications.

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.

Duglas holds a Bachelor of Science degree in Biology with specialization in Molecular Biology, Biochemistry and experience in preclinical biochemical research. He adds to his career more than 13 years of experience in Regulatory Affairs in multinational companies such as P&G, J&J and Roche. With an extensive knowledge of the LATAM regulatory landscape for medical devices and pharmaceuticals, he works on strategic approaches to cooperate with regulators to strengthen the regulatory systems, playing actives roles at different regulatory/health working groups on industry associations like AdvaMed. Duglas currently holds the position of Global Head of LATAM Regulatory Policy part of the Global Regulatory Policy & Intelligence group at Roche.

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.

Specialist in Pharmaceutical Management and Pharmaceutical Market, with a master’s degree in Intellectual Property and International Trade and a bachelor’s degree in law. Experience as a University Teacher in the subjects of Pharmaceutical and Medical Ethics and International Trade. He has over 12 years of experience in technical Regulatory Affairs, Pharmacovigilance, and Regulatory Policy.

Leonardo Semprún is currently Senior Director, Global Regulatory Policy at MSD. In this role, Leonardo is responsible to define and execute a regional regulatory policy plan that addresses current and future needs, while also advocating for and anticipating regulatory change with LATAM-based regulators and multilateral organizations. He has worked with governments, regulators, trade bodies and other external stakeholders to shape regional regulatory policy. Leonardo' work in the industry spans over 20 years, across regulatory, quality, intellectual property and policy functions

With over 20 years of experience in the pharmaceutical industry, Ricardo brings a deep understanding of clinical research to his role as Head of Clinical Operations for Latin America at Fortrea. His career has spanned both large pharmaceutical companies and CROs, providing him with a comprehensive perspective on drug development. Ricardo has held leadership positions across diverse therapeutic areas, overseeing clinical teams in multiple countries. Passionate about driving operational excellence and delivering high-quality clinical trials, he is dedicated to advancing patient care through innovative research.

Patient Safety Manager at PGA Farma responsible for supporting activities related to patient safety, in clinical trials and post marketing activities, for different pharmaceutical companies with the objective to help them reach their internal process with high performance and quality according to requirements from different healthy authorities. Professional with over 20 years of experience in Patient Safety in national and international pharmaceutical industry, working on different kind of operations like Pharmacovigilance, Medical devices, Cosmetovigilance and Nutrivigilance with activities and management related to clinical development and post marketing.

Susan Zavala is a Pharmacist with more than 14 years of experience, mainly in regulatory affairs. She has studied a Master in Biotechnology, as well a Master in Pharmaceutical Legislation and Intellectual Property. Over her more than 10 years at DIGEMID, she has work as a CMC reviewer of biological products, also, she has participated in the elaboration of regulation and procedures related to the sanitary register. Susan has participate as a speaker for several national and international events organized by DIGEMID, MFDS, CASSS, DIA and PAHO. Currently, she is the coordinator of the reviewer CMC team of biological products.

Viviane brings over 26 years of Medical Information (MI) experience to her role as Regional Lead for Pfizer in Emerging Markets and China. As part of the Global MI Leadership team, she has been instrumental to evolving MI practices, from establishing global processes and regional contact centers to pioneering digital channels like chatbots and WhatsApp. Passionate for innovation, she has been involved with exploration of GenAI for MI use cases. At the core of her work is a dedication to patient-centric strategies, ensuring that the voice of the customer informs company decisions. Viviane holds a Bachelor’s in Pharmacy-Biochemistry, an MBA in Marketing, and a post-graduate certificate in Management. She is based out of São Paulo, Brazil.

Jorge Azar is currently Senior Area Regulatory Director for Latin America with 25 years’ experience on different roles at local, regional and global level in the Regulatory Affairs field, including product strategy, regulatory policy and intelligence. Jorge earned a degree in Pharmacy and a Master's degree from Universidad Central de Venezuela. 

Vivienne has a degree in Pharmacy and Biochemistry from Universidade Paulista, a specialization in Clinical Pharmacology from the Brazilian Institute of Development and Hospital Research (IPH), and a Certificate Course in Principles and Practice of Clinical Research from Harvard Medical School – USA/Brazil - 2009. She has over 27 years experience in the pharma industry, leading teams in clinical research for Schering do Brazil and Novartis. She is currently the Medical Science Manager at Libbs. She has nine years experience as a Study Coordinator at Dante Pazzanese Hospital of Cardiology. She has experience as a team manager in Clinical Research, Bioequivalence, Medical Science Liaison, Medical Communications and Medical Information.

Yoon Jeon (Jamey) Kim, the Director and North Cluster PV lead for Latin America at MSD, has 23 years of experience with the company. She provides strategic leadership for cluster countries (Colombia, Ecuador, Venezuela, Central America, and the Caribbean), with an extensive background in pharmacovigilance, regulatory affairs, and clinical trials. Additionally, she chairs the post-approval safety monitoring program review committee within the company. Previously, she held roles as Country PV lead and Regulatory Affairs manager at MSD Korea. She is a pharmacist with a master’s degree in pharmaceutical technology and a bachelor’s degree in pharmacy from Ewha Womans University in South Korea.

Juliana Leite-Schnell is a PharmD and regulatory affairs professional with 20 years of experience including drug development & established products across multiple geographies. Earlier in her career she held several regulatory affairs positions in her home country Brazil. In May 2005 she joined AbbVie as a member of the Brazilian regulatory team and in 2009 transitioned to the Latin America team located in the US. In 2016, Juliana became the US & Canada Immunology lead for the original NDA of RINVOQ®. In 2019 she became a global regulatory lead and worked in different therapeutic areas such as rheumatology, gastroenterology, and dermatology. In June 2023 she transitioned back to Latin America as the Area Head for regulatory affairs.

Patricia is a PharmD with 20 years’ experience in R&D within pharmaceutical industry. She is passionate about innovation applied to healthcare, with solid experience in medical information, project management, medical affairs, and regulatory affairs. Currently, she is responsible for medical information content-related activities across all therapy areas in Emerging Markets and China Medical Information at Pfizer.

I was born in Mexico City, and hold a BSc. in Biomedical Sciences, a MSc. in Biochemistry and further specialized in Pharmacoeconomics. With a background in Medical Information and Safety gained in CROs such PPD and ICON, I took on the role of Medical Information Lead at Shire, now Takeda, for Latin America in 2017. Ever since, I have played a pivotal role co-leading the transformation of medical information services in LATAM. I have contributed implementing custom responses, developing content tailored for the region, and actively participating in digital projects to keep streamlining medical information processes. I have also nurtured relationships with internal stakeholders across the region, fostering stronger collaborations.

Mr. Barra, President-Director of Anvisa, graduated in Medicine from Foundation Souza Marques in 1986 and had his residency in Vascular and Endovascular surgery done at Marcílio Dias Naval Hospital (HNMD) in Rio de Janeiro. MBA in Health Services Administration at Federal University of Rio de Janeiro, in 2012. In 1987 joined Brazilian Navy as a medical officer. In 2015 he was promoted to the rank of Rear Admiral, the second highest rank in the Medical Corps. Retired from the Navy in February of 2019, was approved by the Brazilian Senate to the position of Anvisa’s Director in July of the same year. He was later confirmed as President-Director in October 2020. In March 2023, was appointed as ICMRA's second vice-chair.

Gloria Bocardo is currently Director - Regulatory Affairs CMC at MSD, where she is part of the International CMC LATAM team. In this role, Gloria is responsible for developing CMC regional regulatory strategies for new marketing applications and post-approval changes for both small and large molecules, and for ensuring awareness of regional regulatory policy trends in the region, partnering with Regulatory Affairs and trade associations to pursue priority advocacy plans on CMC topics. She has over 23 years of experience in the pharma industry, in areas spanning Regulatory Affairs CMC, Technical Operations and Quality.

Physician graduated from UNICAMP, São Paulo, Brazil, with a master's degree in Gerontology. Clinical experience in palliative care and over 11 years of experience in the pharmaceutical industry, working in various areas including Medical Affairs, Clinical Research, Innovation, and Portfolio and Pipeline Management. Formerly worked at multinational and national companies including Abbott and NC Pharma. Currently responsible for MedInfo, Clinical Studies, and Medical Scientific Communication at Merz Aesthetics in a Latin America role.

Head of the Post-Marcket Surveillance Office at the Brazilian Health Regulatory Agency (ANVISA). Holds a permanent position at ANVISA as goverment employee, Health Regulatory Expert, since March 2005. Graduated in Pharmaceutical Sciences from the University of Brasília - UnB (2004), Specialist in Bioethics from the University of Brasília - UnB (2005), Specialist in Health Surveillance from the Oswaldo Cruz Foundation - FioCruz (2007) and Specialist in Data Science and Artificial Intelligence from Hospital Alemão Oswaldo Cruz - HAOC (2023).

Suely Inoue currently serves as the Clinical Development Executive Manager at Eurofarma Labs, a Brazilian company, and she is dedicated to establishing the clinical strategy and generate clinical development plans, clinical data and documentation to support new products marketing authorizations in all Latin American countries. With over 30 years of experience working for different pharma companies (B-MS, Abbott, Amgen and Eurofarma), she cumulated experience in Regulatory Affairs, HEOR and Clinical Operations/ Clinical Development in different therapeutic areas. She holds a BSc. in Pharmacy and Biochemistry from the University of Sao Paulo and MBA from the Fundaçao Instituto de Administraçao (FIA).

Michelle Limoli is the Senior International Health Science Advisor in FDA’s CBER. She is responsible for coordinating and collaborating on activities and strategic programs with various international organizations and governments, as well as within the CBER. During her career at FDA, she has coordinated activities in various harmonization and multilateral initiatives such as ICH, VICH, ICCR, GHTF, IMDRF, APEC RHSC, OECD, and WHO. Michelle joined CBER after having worked in the Center for Drug’s international programs, and the Office of the Commissioner, where Michelle served as the Director of FDA’s Europe Office. Michelle is a clinical pharmacist with both hospital and community pharmacy experience.

Mariângela is a dedicated pharmacist with nearly 10 years of experience in the pharmaceutical industry, having made significant contributions at companies like Roche and Eli Lilly. While she has worked in the Medical Affairs department, her career has been largely devoted to pharmacovigilance, with a focus on right to operate documents, regulatory requests tied to new drug applications and post marketing setting, and the signal management process. Ensuring patient safety is at the core of her professional and personal commitments.

Jeimmy is a bacteriologist and clinical scientist with a master's in Public Health with emphasis in Global Health. She has 5 years of experience in pharmacovigilance (PV) and 3 years in medical information. She worked on the PV and Medical Information team at Roche Colombia and is currently dedicated to PV and risk management. She has led processes including ICSRs management, health authority reports, PV agreements, medical information management, digital communication on safety information, signal management, healthcare professional training and risk management. Recently she has been involved in addressing safety needs from therapeutic areas by providing evidence-based solutions to address safety uncertainties in the healthcare ecosystem.

Ana Carolina Marino is Head of the International Affairs Office at ANVISA. Holds a permanent position at ANVISA as goverment employe, Health Regulatory Expert, since March 2007. Has experience in both technical and management roles: Advisor at the Fourth Directorate/ANVISA; Head for Inspectorate and Law enforcement department; Manager for the Medical Device Inspectorate and Law Enforcement Department; Manager for the Drugs Post Approval Changes Office. Pharmacist with a degree from the University of Brasília (2002), and postgraduate qualifications in Health Regulation and Surveillance (2009) from Fiocruz and Pharmaceutical Technology (2012) from the Federal University Fluminense. Represented Anvisa in ICH, PICs, IMDRF and MDSAP.

Flávia Neves Rocha Alves holds a degree in Pharmacy-Biochemistry from the University of São Paulo (1995), a master's degree in Public Health (Planning and Management of Health Services) from the National School of Public Health/Fiocruz (2004) and a specialization in Health Surveillance from Fiocruz (2008). She holds a permanent position at ANVISA as government employee, Health Regulatory Expert, since April 2005, having worked in different areas: medicines marketing authorization, pharmacopeia, toxicology, inspection, regulation. She currently holds the position of Head of Pharmacovigilance at the Brazilian Health Regulatory Agency (ANVISA).

BA in Advertising MA in ORGANIZATION COMMUNICATION MANAGEMENT Attended the PhD in PUBLIC AFFAIRS, POLICIES AND GOVERNMENT program. He is the current director of the Office of Institutional Relations of ANMAT. He has worked for ANMAT since 1994. Among other functions, he was the Head of the Observatory and the Coordinator of the Institutional Communication Program. From 2014 to 2019, he was a Member of the Subgroup of Communication on behalf of ANMAT at the Pharmaceutical Cooperation Scheme (PIC/S). He participated in several talks and congresses. He is a professor at the Master´s of Science in Regulatory Science of Buenos Aires University, a MSc program jointly developed by the School of Pharmacy and Biochemistry and ANMAT.

Leonardo Santos is a pharmacist, PhD in Immunology from University of Bahia, Brazil. He is a health regulation specialist from The Brazilian Health Regulatory Agency (ANVISA) since 2014. He worked with the evaluation of Chemistry, Manufacturing, and Controls (CMC) of pharmaceuticals for post-approval changes. After spending almost four years working with health control of pharmaceuticals, medical devices, food, and cosmetics importation in different positions, he is now an assistant in the general Office of Drug Products leading the process of eCTD implementation.

Dr. Daniela Varela Luquetti completed her medical and clinical genetics training in Brazil. She pursued additional experience in research through a PhD in Epidemiology and Public Health (Brazil) and the Certificate of Public Health Genetics at the University of Washington (UW, Seattle). She joined the faculty at the School of Medicine of the UW in 2013 becoming an Associate Professor in 2019. At the UW, she designed and conducted multi-center studies on the genetic and non-genetic causes of craniofacial congenital conditions. In 2021, she joined the FDA in the Division of Rare Diseases and Medical Genetics as a clinical reviewer providing her 20 years’ experience as a clinical scientist in rare diseases.

Ana Adame is Brazilian, hailing from Rio de Janeiro and currently residing in São Paulo. She is a pharmacist with a Master's degree in Research, Development, and Management in the Pharmaceutical Industry, as well as an MBA in Leadership and Innovation. Ana began her professional journey at GSK, specializing in Medical Information and Scientific Support. In 2017, she made the transition to Takeda, where she took on a crucial role overseeing Medical Information and Customer Service in Latin America. Currently, Ana leads the management of Medical Information content for Vaccines, Oncology, Neuroscience, and Immunology, in addition to various key activities related to Global Medical Information across Latin America & Canada.

Priya Bahri, RPh, PostGradDipEpi, PhD, at EMA since 1996, is now EMA's Lead Pharmacovigilance and Risk Management Guidance and Policy. In this role, she also instigates research and regulatory frameworks for risk communication, stakeholder engagement for pharmacovigilance and implementation of risk minimisation in healthcare. Pro bono, she is active in the learned societies ISoP and ISPE and as associated researcher at Utrecht University. She is the editor of the Springer textbook "Communicating about Risks and Safe Use of Medicines - Real Life and Applied Research", published in 2020.

Medical Affairs executive with 14 years of experience in pharma industry, from different leadership positions under Medical Affairs organization at Amgen and DS: MSL Mgr, Medical Excellence & Capabilities Mgr, Field Med. Value & Access Mgr, Medical Mgr and MSL Head. She has strategically developed and transformed Field Med. Teams local, regional and globally and led matrixed and dynamic teams, partnering cross-functionally as the bridge between R&D and commercial to enhance business impact and scientific knowledge. Pharmacist with master degree in Oncology, Carolina brings also 5 years of clinical experiency from Oncology Day Care Center, Hospital and Clinical Research Site as Study Coordinator.

Isabelle has joined Merck KGaA since 2005 where she has held growing managerial roles in RA and RA CMC as Head of Department. She currently is Head of International Global Regulatory & Scientific policy at Merck and as such actively engaged in international regulatory policy as member of IFPMA since 2014, representative at ICH TrSC, EFPIA and PhRMA ICH WG. Prior to joining Merck, she has worked for several Companies in areas of small and large molecules including in Clinical Development for Servier Laboratories, and assumed various manufacturing site managerial responsibilities within Sanofi GMP QA & RA. Isabelle holds a MSc and a Pharm. D from Lyon (France) coupled with an MBA from Paris (EAP) High Business School.

Quality Assurance Manager at Novo Nordisk Pharmaceuticals Brazil; Twelve years of experience in the pharmaceutical industry, working with Quality Management Systems and Pharmacovigilance, as well as their tools and requirements; Extensive experience in Quality and Safety processes within the business, team management, and supervision of third parties; Currently serving in the interim management of Pharmacovigilance, Customer Service (SAC), and Scientific Information Service (SIC) departments.

I hold a bachelor's degree in veterinary medicine and a master's and a doctoral degree in the same field from the University of São Paulo, Brazil. I have carried out research on various aspects of veterinary medicine, such as mechanical ventilation, critical care medicine and pain management. Since 2019, I have been working as a medical information coordinator at Libbs Famaceutica. In this position, I am in charge of providing precise and current information on the company's products and services to health professionals, customers, and regulatory agencies.

Juhaeri Juhaeri, Ph.D., is Vice President and Global Head of Epidemiology and Benefit-Risk at Sanofi. An epidemiologist and statistician, he has held global leadership roles in Medical and Pharmacovigilance functions for more than two decades in the pharmaceutical industry. A passionate leader, he has built and developed different new teams at Sanofi and led successful programs leading to products’ approval and maintenance. He has led different working groups in various public-private partnerships in benefit-risk evaluation, pharmacovigilance, real-world evidence, and patients. He holds adjunct faculty positions at the School of Public Health, University of North Carolina Chapel-Hill and at IPB University, Indonesia.

Juan is a Senior Research Analyst at the Center for Innovation in Regulatory Science. He holds a Bachelor's degree in Pharmaceutical-Biological Chemistry and has diverse experience in quality assurance, production, R&D, and regulatory affairs. Juan supports a wide range of regulatory science research projects to advance international regulatory policy development. Previously, he worked at IQVIA, where he supported pharmaceutical industry projects across Mexico and Central America on market access and regulatory landscape. Prior to that, he worked at the Federal Commission for the Protection of Health Risks (COFEPRIS, NRA of Mexico), where he supported projects to streamline scientific reviews and comply with regulatory timelines.

Master's degree in Science from the Centre for Research and Advanced Studies of the National Polytechnic Institute, and a Bachelor’s degree in Pharmaceutical Biochemistry, with a specialisation in toxicological sciences, Ms. Miriam Jackeline Loera Rosales is the current Commissioner for Evidence and Risk Management at the Federal Commission for the Protection against Sanitary Risks (COFEPRIS), where she addresses topics such as pharmacovigilance, environmental health, occupational health, and the management of sanitary risks in the Mexican population.

Gabriela is a PharmD with a specialization in Pharmaceutical Medicine from Sírio-Libanês and a Leadership certification from Harvard Business School. With over 10 years of experience in Medical Information, Medical Communication, and Medical Writing, she currently leads the Medical Information department at Aché Laboratórios Farmacêuticos, Brazil. Throughout her career, Gabriela has significantly contributed to the expansion and development of the Medical Information and Medical Communication roles within the company, enhancing their strategic contribution on the drug lifecycle—from feasibility to regulatory, marketing, and post-marketing stages.

Raquel is a highly experienced professional with over a decade of expertise in the regulatory field, specializing in the development and implementation of robust strategies for the successful launch of innovative medicines in Brazil. With a deep understanding of the patient's needs and the importance of access to innovative treatments, she have consistently focused her efforts on prioritizing patient well-being throughout the regulatory process. Throughout her career, she exhibited a genuine passion for leading and empowering teams, fostering a collaborative and driven environment that enables individuals to thrive. She is dedicated to navigating complex challenges ensuring regulatory compliance while propelling the advancement of treatmen

Christelna is the COO of South African Health Products Regulatory Authority (SAHPRA). She holds a Master of Business Administration (MBA) from Edinburgh Business School (Heriot Watt University) and a BPharm Degree from the University of the North West. Before joining SAHPRA, Christelna spent 13 years in the Pharma Logistics sector in Quality Assurance/Regulatory Compliance and Logistics Operations roles and developed an appreciation for the value Lean Six Sigma approaches, tools and process improvement can have for organisations. The first 8 years of her career in the Retail and Courier Pharmacy sector solidified the passion for prioritizing patient well-being and out-of-the box thinking.

More than 35 years of professional experience that spans from academia and government to industry. It includes clinical practice in anesthesia and pain management, clinical and basic research in behavioral pharmacology, and regulatory affairs during the last 20 years, first at Merck Research Laboratories in 2001 and subsequently at Covance/LabCorp/Fortrea since 2013. In clinical she developed the oral morphine program for cancer pain, and as a behavioral pharmacologist, worked in animal models of drug abuse. Became Head of Global Regulatory Affairs, Product Development and Market Access Consulting in 2018, and since 2024 is serving as Fortrea's Chief Regulatory Liaison Officer.

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.

Sarah Venti is a Regulatory Counsel at the U.S. Food and Drug Administration (FDA). Sarah has been with the FDA since 2013, first in the Center for Tobacco Products, then in the Office of Regulatory Affairs, and now with the Center for Drug Evaluation and Research (CDER). Sarah is in CDER’s Office of Compliance where she focuses on policy and compliance issues related to prescription drugs and the pharmaceutical supply chain, including the implementation of the Drug Supply Chain Security Act. Sarah graduated with her J.D. from American University’s Washington College of Law in 2010.

Patricia Wu is Senior Vice President at Access Partnership, a global public policy advisory firm, where she supports leading health and life sciences companies navigate the policy landscape throughout the Asia Pacific and Latin American regions. Additionally, Patricia serves as the Chair of the Health Working Group for the Americas Business Dialogue, which is the private sector voice before the Inter-American Development Bank on health issues. Previously, Patricia was Vice President and Managing Director at C&M International and has held positions at The Estée Lauder Companies and J.P. Morgan. She holds an MBA from Harvard Business School.

Mario Alanis has domestic and international, public sector experience in health regulation, economic analysis, social policy and international trade negotiations. Proven track record of successfully leading teams working on complex, sensitive issues with governments, multilateral organizations, non-governmental organizations and the pharmaceutical and medical device industry. Currently he collaborates as Senior Advisor to the Center for Innovation in Regulatory Science, (CIRS) participating in diverse strategic projects for the Latin American Region. He concluded a Ph.D. in Economics at the University of Pennsylvania and the Bachelor program at the TEC de Monterrey in Mexico.

Jaime is a dedicated healthcare professional from Ecuador, currently serving as the Director of Risk Profile Technical Direction for the National Agency for Regulation, Control, and Sanitary Surveillance. He holds multiple master's degrees in Public Health and Health Institution Management, alongside a medical degree. Over the years, He has held various leadership roles and is committed to ensuring equitable access to healthcare. He has participated in several training workshops and seminars focused on health management and quality assurance. He is passionate about improving community health outcomes.

Pharmacist, MBA, over 15 years of expertise in the medical area of rare diseases pharmaceutical industry. Solid experience as Medical Information and Customer Services head, leading both internal and third-party teams. Background in Pharmacovigilance, Medical Projects and field medical activities as MSL. Currently as Medical Information Associate Director for Americas at PTC Therapeutics.

Gustavo is a specialist in transactional, regulatory and intellectual property matters related to the life sciences, health, food, agribusiness, technology and biotechnology industries. He represents local and international clients on contractual matters, including on licensing, collaboration, development and contracts of similar nature. He also advises and represent clients before regulatory and government agencies, such as the Brazilian Health Regulatory Agency, the Brazilian Agency of Supplementary Health, and the Ministry of Agriculture, Livestock, and Food Supply. He works with healthcare compliance and legal matters involving privacy and personal data protection.

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.

Claudia is a speech therapist with a masters degree in Educational Psychology. At Roche, she leads a Patient Experience team working closely with Patient Communities. Prior to Roche, she has held roles in corporate settings and as a consultant, focusing on brand Patient Partnership, Patient Centricity, especially in Market Access, Patient Advocacy, Advocacy, Health Policy and Patient Support Programs including digital strategies. Claudia is recognized for her contributions to thought leadership, sharing insights through articles, speaking engagements, and mentorship programs. She believes a Patient Inclusive Mindset within her company is a relevant factor to the achievement of our vision focused on improving customer/patient experience.

Joerg has 20 years of extensive experience in the pharmaceutical industry within different functions in the quality field for development and commercial products. He serves as Global Quality Manager in Roche Pharma Global Technical Operations overseeing Roche’s global in-country testing activities. Joerg has been a contributing member in the industry via IFPMA/EFPIA. As global Policy Lead, he co-/authored several publications and industry positions on in-country testing and Advanced Therapy Medicinal Products (ATMPs) and functions as scientific reviewer for several journals. He is engaged as conference speaker and in numerous workshops/capability buildings with regulators from around the globe.

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 Evidence Generation Lead for Emerging Markets at Pfizer.

Marcelo has extensive experience in Public Health and Pharmacovigilance. Over his 15+ year career, he has actively contributed to public health initiatives, including his work with the pharmaceutical program at the Municipal Health Department of São Caetano do Sul. Since 2012, he has been dedicated to the Clinical Trials and Pharmacovigilance Center at Instituto Butantan. Through his work in Pharmacovigilance, he has become deeply involved in the clinical safety of vaccines, both for vaccines developed in-house and those arising from technology transfer process. Currently Pharmacovigilance Specialist, he has actively contributed to the implementation and strengthening of safety signal detection process at Instituto Butantan.

I am physician specialized in internal medicine, pharmacology, medical audit and forensic medicine. I am teacher for pharmacology at University of Buenos Aires Medical School. I have worked for 31 years at ANMAT - Argentinean Administration Food Drugs and Medical Technology - and currently I am Director of Clinical Research and Management of the Medicines Registry, leading the evaluation and commercialization approval of medicines.

Waleuska Spiess is a PharmD with more than 25 years´ experience in Clinical Research. She started at Pfizer as a CRA and increased her responsibilites in the area of Project Management and People Development which is really her passion. She has experience working in CRO environment where she had opportunity to learn and focus on Customer experience. She is currently Clinical Operations Portfolio Leader working locally and globally in Pharma Development Clinical Operations Group and Country Therapeutic Area Lead for Immunology, Opthalmology, Neuroscience and CardioMetabolism at Roche Brazil.

Gustavo holds a degree in Pharmacy-Biochemistry from the University of São Paulo (USP) and earned his PhD in Pharmacoepidemiology and Public Health from the State University of Campinas (UNICAMP). Gustavo brings over 10 years of experience in the pharmaceutical industry, having worked in Medical Affairs, Clinical Research, Medical Information, and Market Access in different companies, such as Roche, IQVIA, Teva Pharmaceuticals, and PPD/Thermo Fisher Scientific. Currently, he works as a Health Technology Assessment Partner (Value Strategy & HEOR Manager) at Roche, focused on the value proposition strategy for pricing and reimbursement of medicines in the Brazilian healthcare system.

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

Jared R. Auclair, Ph.D. is currently the Interim Dean College of Professional Studies, Vice Provost Research Economic Development and Director of Bioinnovation in the Office of the Provost at Northeastern University. As Vice Provost Research Economic Development, Dr. Auclair works to strengthen the bonds between our education and research missions. As Director of Bioinnovation, Dr. Auclair works to leverage important University activities around biotechnology, bringing together experts from a wide range of disciplines and backgrounds to advance the expansion of Northeastern life sciences programs.

Química Farmacéutica, egresada de la Universidad del Norte. Con más de 10 años de experiencia en el Ministerio de Salud Pública y Bienestar Social. Actualmente Jefa Interina del Departamento de Medicamentos Biológicos y Radiofármacos. Dirección Nacional de Vigilancia Sanitaria - DINAVISA 2016 - 2021 Jefa del Centro regional de Vacunas - Programa Ampliado de Inmunizaciones - MSP y BS. Con capacitación permanente local e internacional en biológicos.

Master and PhD student in Pharmaceutical Sciences with an emphasis on Health Technology Assessment / Patient Involvement at Federal University of Parana; MBA in Public Policies and Social Rights; Psychologist; Diplomatura Health Literacy y empoderamiento. Founder and CEO of United for Life Institute (NGO for Cystic Fibrosis, Rare and Respiratory Diseases); Consultant at Supera Consulting; Speaker. Member of the ISPOR; Brazilian Study Group on Cystic Fibrosis and Universidad del Paciente y la Familia. She was late diagnosed with Cystic Fibrosis at the age of 23, and, since then, has dedicated herself to studying and working on the subject, also focusing on public policies, HTA and Advocacy.

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.

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 Superintendency of Sanitary Regulation. 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.

Juliana Perlow is currently Executive Director at MSD, where she leads the International CMC - Latin America team. In this role, Juliana is responsible for leading the regional strategy and execution of regional CMC post-approval variations and initial registration submissions for both small molecules and large molecules, including biologics and vaccines. A pharmacist with specialization in clinical pharmacology and project management, she also has an MBA. Juliana has more than 25 years of experience in pharmaceutical industries working in regional regulatory CMC and regulatory affairs functions. Juliana co-chairs the ISPE Latin America Regulatory Quality Harmonization Committee.

Pharmaceutical Chemist graduated from the Faculty of Chemistry of the University of the Oriental Republic of Uruguay. Drug Evaluator Chemist of the Drug Department of the Ministry of Public Health from 2006 to 2019, specialized in the evaluation of Biotechnological Drugs (training carried out at the Spanish Agency for Drugs (AEMPS) among others). Head of the Evaluation Sector of the Drug Department of the Ministry of Public Health from 2019 to date. Technical Director of the Comisión para el Control de Clidad de Medicamentos, official drug quality control laboratory since January 2020 to date.