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.

Industrial Pharmaceutical Chemist with 17 years of experience in the pharmaceutical industry. Founder and Member of #PharmacovigilanceEnEspañol. Founder of "JBA Farmacovigilancia". Advisor of the Pharmacovigilance Institute. Member and Mexico´s ambassador of the International Society for Pharmacoepidemiology (ISPE). Member of the LinkedIn program #LinkedInCreators. Pharmacovigilance Professor for Latin America. Ambassador for LATAM of the Global Pharmacovigilance Society (GPS). Invited coordinator of the Pharmacovigilance academic program at UNIBE. He collaborated with companies such as Wyeth, GlaxoSmithKline, Merck Sharp & Dhome and Pfizer. Currently, he works as a Global Auditor of Pharmacovigilance for Novartis.

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

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

Raphael has more than 16 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 is the Regulatory Advisor for Latin America in Global CMC at Pfizer since 2017. She holds accountability for partnering with manufacturing organizations and Regulatory Affairs while providing regional regulatory expertise to CMC Product Strategists, addressing strategic issues, contributing to the development of policies and positions on draft regulations and external engagement on CMC topics. Based in Brazil, she has over 20 years of experience in Quality, Regulatory and CMC areas and held leadership positions in Regulatory Conformance, Quality Operations and Regulatory Affairs.

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, with special focus on Brazil.

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 12 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 consumer products, medical devices and pharmaceuticals, he recently has worked on strategic approaches to cooperate with regulators to strengthen the regulatory systems and has played leadership roles in industry associations like FEDEFARMA. Duglas currently holds the position of Head of LATAM Regulatory Policy part of the Global Regulatory Policy & Intelligence group at Roche Diagnostics.

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 differenece healthy authorities. Professional with over 20 years of experience in pharmacovigilance in national and international pharmaceutical industry, working on different kind of operations like Pharmacovigilance, Technovigilance, Cosmetovigilance and Nutrivigilance owith process related to clinical development and postmarketing.

Susan Zavala is a Pharmacist with more than 10 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 7 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 international events organized by 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.

Sonia has over 15 years of professional experience in the biopharmaceutical industry. As legal counsel specialized in commercial, business, and corporate law, she has provided extensive legal advice to pharmaceutical companies in the Latin America region, including pharmaceutical law, intellectual property, business transactions, regulatory matters and healthcare compliance. She joined Johnson & Johnson in 2016 as Latin America Lead for Global Regulatory Policy & Intelligence and later expanded her role to cover U.S. policy work on topics such as Cell & Gene Therapies. She holds a Master of Laws degree on International Trade Law from the University of South Africa and a Law degree from the University of Buenos Aires, Argentina.

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.

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.

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.

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.

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.

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.

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.

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.

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).

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.

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

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.

Joerg has 20 years of 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. Joerg received a PhD in biochemistry from the University of Hannover/Max-Planck-Institute of Biochemistry, Germany.