Pharmacist, with MBA and Masters in Public Health, with more than a decade focusing on regulatory strategies to strengthen health systems across the globe.

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.

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

Urimara Argotti is the LATAM Regional Regulatory Policy Manager, Product Development Regulatory Department at Roche based in Mexico, responsible for leading regional Regulatory Policy activities, developing and executing a regional policy roadmap and associated Roche positions to drive global regulatory convergence in LATAM. She is involved in regional and global initiatives for regulatory systems strengthening. She has over 19 years of experience in the Life Science Industry, mainly in the Regulatory Affairs, Regulatory Policy and Quality Assurance field. Active member of the Latin American Federation of the Pharmaceutical Industry (FIFARMA), Chair of the Regulatory and Biological Working Group, participates in EFPIA LATAM Network.

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.

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.

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.

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.

Country Safety Head for Sanofi Brazil. Industrial Pharmacist with over 16 years of experience in Pharmacovigilance, Cosmetovigilance and Materiovigilance operations in multinational pharmaceutical industries. As part of her career, also assumed responsibilities for Call center, Patient Support Program and Medical Governance areas. Active member of local and 119egional Pharma Associations, has been participating in important projects to strengthen Pharmacovigilance in Brazil.

Michelle Argüelles is currently the Executive Director of Clinical Reserach at MSD Mexico. She has more than 20 years of experience in different roles, with increasing levels of responsibility moving from Quality Asoociate to CRA, CPM, CRM, and in her latest Directive experience as Head of Project Management teams, for Primary Care Portfolio in US, Canada and LATAM , Head of the Regional Operations Center and finally as Regional Operations Head in LatinAmerica. Michelle has a Master in Business Administration, a Bachelor in Pharmacy & Biochemistry, she is expert leading and coaching high performing teams, Michelle is certified in six sigma yellow & green belt, holds a diplomate in Agile methodologies and in Patient Advocacy. 

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.

Lorena Larrosa is currently working as Manager, Regulatory Affairs for Latin America at Abbvie. in this role she develops and executes regulatory strategies in alignment with Global and Affiliate teams for several products and indications, simultaneously across countries in Latin America. She is pharmacist with 19 years of experience in pharmaceutical companies, both national and international (Merck, Novartis and AbbVie) having broad expertise in Regulatory Affairs, and Quality Assurance areas. She has also expertise on Regulatory Policy matters having worked as member of trade associations (CEFA and Fifarma).

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.

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.

Tamei Elliott, MS, serves as the Associate Director of Scientific Programs for the Americas region at DIA. In this pivotal role, she is responsible for identifying and prioritizing content areas and topics crucial to DIA constituents. Tamei assesses the implications of significant regulatory and health policy changes, seamlessly integrating relevant content into the development and advancement of DIA conferences and courses. Her responsibilities extend to overseeing content development and strategy within the Americas region.

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.

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.

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.

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.

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.

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.

Pharmacist specialized in marketing management with 30 years of professional experience in the goverment and industry sectors, as a consultant for medicines and health technologies and manager of regulatory affairs and quality assurance at the regional level. Has worked as an advisor on issues of pharmaceutical legislation, pharmacovigilance, post marketing surveillance, clinical studies, environment and intellectual property in the medical device, pharmaceutical, cosmetic and food sectors.

Pharmacist with a Master (MS) in Regulatory Affairs and Health Policy with more than 20 years of experience in regulatory affairs in a Global Organization. Currently, RA Head of New Product Strategy for Latin American countries at Novartis. In collaboration with the local, regional, and global cross-functional teams, accountable for developing innovative regulatory strategies for efficient approvals of projects under responsibility. Regulatory experience includes modalities such as in-vivo gene-therapy, biologics and small molecules in multiple therapeutic areas, mainly rare diseases, oncology, hematology, ophthalmology and cardiovascular.

Pharmacist, Master of Business Administration (MBA) in Business Administration. Solid knowledge of Pharmacovigilance and Medical Devices. Experience in Risk Management and Post-Marketing Vigilance of Medical Devices, with a focus on Patient Centricity and the development of Additional Activity Minimization Measures to provide support and health literacy to patients and healthcare professionals. Experience in project coordination and ability to work in cross and self-managed teams to achieve results and ensure that more solutions can be delivered to patients and society.

Graduated from the Faculty of Medicine of the Universidad La Salle; specialized in clinical neurology at the University of Paris VI Pierre et Marie Curie, Paris, France; awarded a Diploma in Electrophysiology at the same university. She has been classified as one of the one hundred most influential women in Mexico over the last ten years (2009-2019) and in 2019 was nominated as Leader of the Year in the Science category at the special 2019 edition of the 25 Executive Women Leaders. In 2020 she headed one of the Pfizer Mexico´s most important projects, the COVID-19 vaccine, achieving one third of the total sample in Latin America alone in record time. In 2021 she was appointed as Area Head for EUCALA (Europa, Canada and LATAM).

Lawyer and notary, graduated from the University of El Salvador, has a master's degree in Administrative Law and Public Policies, specializing in Health, Pharmaceutical, Labor and Labor Procedural Law; Sanctioning Administrative Law and Administrative Procedure. With experience in health regulation and surveillance, administrative management and public policies in public health. He has held executive and technical positions at the NRA as a Specialist Technician in Regulatory Litigation, Secretary for the Investigation of Sanctioning Procedures, Head of the Regulatory Litigation Unit, Acting Head of the Inspection, Oversight and Good Practices, Legal Coordinator of Regulatory Processes and currently as a National Director.

Mr. Hamel spent his last 23 years working with the Biologic and Radiopharmaceutical Drugs Directorate (BRDD) at Health Canada as Senior Evaluator and Division Manager. He is currently Associate Director with BRDD. Mr. Hamel was involved with reviewing the CMC information pertaining to CTAs, NDSs and Post-Marketing changes associated with Biotherapeutics and represented Health Canada on the WHO drafting group in charge of developing the WHO Guidelines on procedures and data requirements for changes to approved biotherapeutic products. Mr. Hamel is also a member of the ICH M4Q EWG and ICH Q12 IWG and leads its implementation in Canada. He is pleased to share his experience with the ICH Q12 pilot program in Canada.

Alan Hochberg is a Scientific Enablement Leader at Genentech, involved in bringing innovations into the pharmacovigilance system. He was formerly with ProSanos, where he developed and evaluated signal-detection algorithms. He has worked in bioinformatics and biomedical engineering for the past 38 years, at DuPont, Hologic, and J&J. Mr. Hochberg holds several patents on medical devices and data analysis methods. He received his B.S. degree in Engineering from Princeton University.

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.

Alex Kiazand is the Head of Global Patient Safety, Vaccine & Immune Therapies at AstraZeneca. He has a medical degree from Claude Bernard University School of Medicine, was a hospitalist in France and completed post-doctoral training in clinical research, and epidemiology at Stanford School of Medicine, CA. Alex joined the Industry in 2006 and has led teams of physicians and scientists in the US, Germany, Sweden, & UK. He holds a faculty position and teaches pharmacovigilance courses at the Claude Bernard School of Medicine in France. Alex served as the Chair of IQ-DILI consortium in 2020-22 and has published in several high impact journals. Alex currently heads the Global Patient Safety team in Vaccine & Immune Therapies at AstraZeneca.

Mr. Lemgruber is Regional Advisor on Health Technologies Management at PAHO/WHO, a position he holds since July 2011. He is responsible for providing technical support for the countries in Regulation of Medical Devices, Health Technology Assessment (HTA), and Biomedical Equipment Management. Prior, Mr. Lemgruber was the Head of the Office of Economic Evaluation of New Technologies at ANVISA. He was a member of the National Commission of Health Technologies Incorporation, a member of the MERCOSUR HTA Commission and a rapporteur of the Brazilian Policy of Health Technology Management. Mr. Lemgruber holds a degree in Chemical Engineering, a Masters degree in Public Policies and specialization degrees in Health Economics and Pharmacoeconomics.

Lesley R. Maloney, Pharm.D., is Global Regulatory Policy Lead for Digital Health at Genentech/Roche. She is responsible for shaping the external regulatory environment on integrated and digital solutions, including use of digital health technologies in drug development for digitally-derived endpoints, SaMD, and AI/ML. She was previously Head of US Regulatory Policy for Roche Diagnostics. Prior to joining Roche, Dr. Maloney worked for the U.S. Food and Drug Administration in the Office of the Commissioner, where she served in various roles, including Senior Policy Advisor and Deputy Chief of Staff. Dr. Maloney holds a doctor of pharmacy degree from the University of Oklahoma and did an Executive Residency at ASHP.

Cristina is currently Director at AbbVie where she coordinates regulatory policy and intelligence activities for the Emerging Markets. Cristina worked for Boehringer Ingelheim for 13 years in different roles including Quality, Validation and Regulatory Affairs. Cristina attended Universidad Nacional Autonoma de Mexico where she got her Pharmacy Degree and a Masters in Industrial Administration.

I am pharmacist graduated at University of Sao Paulo (FCF-USP), and I was awarded a MSc in pharmacoepidemiology at Bordeaux University. I am currently PhD candidate at UMC Utrecht (Netherlands) focusing on the research area of drug safety in pregnancy and breastfeeding through IMI-ConcePTION. Besides my academic life, I work simultaneously at Roche in UK as Clinical Safety Director in Oncology Area with more 12 years’ experience in pharmacovigilance in pre-and post-marketing programs.

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

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.

Doctor of Medicine (1993) and First Degree Specialist in Family Medicine (1997) at the "Salvador Allende" Faculty of the Superior Institute of Medical Sciences of Havana. Numerous responsibilities in the Cuban Health System: Municipal Director of Health of the Cerro Municipality in the Havana province; Head of the Independent Section of Optics of the Ministry of Public Health of Cuba; Head of the Department of Medical Technologies of the Ministry of Public Health of Cuba; Director of the National Electromedicine Center, Commercial Director of the Cuban Medical Supplies Company. Since 2019, he has been the Head of the Department of Medical Equipment and Devices of the Center for State Control of Medicines, Equipment and Medical Devices.

I am an Associate Professor of machine learning in healthcare at the Department of Epidemiology of the School of Public Health, University of São Paulo. I served as a visiting professor (2016 and 2020) and visiting researcher (2017 and 2019) at the Harvard School of Public Health. I am the director of the Laboratory of Big Data and Predictive Analysis in Health (Labdaps) at the University of São Paulo, which currently has a team of 25 researchers focused on developing artificial intelligence (machine learning) algorithms to improve healthcare decisions in Brazil, in areas such as improving disease diagnosis and prognosis, and improving the allocation of public health policies.

Dr. Cross is co-founder and Chief Strategy officer of Rymedi, a digital health company providing a digital workflow and data automation platform for testing, treating and monitoring patients across health service providers. Prior to Rymedi, he was a professor of health innovation law, policy, and business at Duke University, where he was founding Executive Director of the Innovation & Technology Policy Lab (ITPLab) and led research, consulting and venture incubation on health innovation. Dr. Cross is an advisor to several health innovation companies and research programs, as well Chair of the intellectual property subgroup of the IEEE Blockchain in Healthcare and Life Sciences Standards Development Working Group.

I began my work at Pfizer as Pharmacovigilance leader in 2011. In March 2017, was appointed as the leader of the Pharmacovigilance Unit for the Americas, which is a hub of the company -based in Costa Rica- dedicated to processing of adverse drug events. Later, in 2020, was appointed director of Pharmacovigilance for Canada and Latin America. I graduated as a pharmacist in 2006 from the Universidad de Iberoamérica and have a specialization in Management Skills and Leadership. Had the opportunity to entrepreneur having my own pharmacy, and, in addition, worked as a professor for Universidad de Iberoamérica. Currently I am in the process of finishing my Thesis for a Master's in Business Administration with an emphasis in Management.

Dr. Rian Marie Extavour is a pharmacist by training, and is the Programme Manager of the Caribbean Regulatory System (CRS), under the Caribbean Public Health Agency (CARPHA). Dr. Extavour holds a Master of Science degrees in Clinical Pharmacy, and in Pharmacovigilance and Pharmacoepidemiology, as well as a Doctor of Philosophy degree. She manages the technical work of the CARPHA-CRS, which supports CARICOM Member States in regulatory functions of market authorization, pharmacovigilance, and post-market surveillance. Her work experience includes pharmacy education, research, consulting in pharmaceutical systems and medicines utilization, and pharmacovigilance.

Pharmaceutical Chemist and Master in public policy, director(s) of the Institute of Public Health of Chile. In January 2020, he joined the ISP after being appointed Head of the National Medicines Agency (ANAMED), a position he assumed through the Senior Public Management System. In August of the same year, he was appointed director(s), a period in which he stands out for his management and leadership in controlling the pandemic through the evaluation and authorization of vaccines to combat COVID-19, in addition to reinforcing the institutional role to support the Ministry of Health in the strategy of testing, traceability and isolation of the SARS-CoV-2 virus through genetic sequencing.

Sandra has hold diverse management and directive positions at Regulatory Affairs, Sales, Marketing, Business Development and R&D for various countries in Latin America and Turkey. Her experience covers from Public institutions to Global Companies: Baxter, Danone and J&J MDs. She has held diverse mgmt. positions in Sales, Mktg, Business Dev. and RA. Sandra has participated as a Faculty Member and speaker for several international events organized by RAPS, ISPOR, COFEPRIS, INVIMA and PAHO. She holds a bachelor’s Degree in Nutrition & Food Sc and a Diploma on Product/Brand Mgmt, by U. Iberoamericana and a Diploma on Enterprise Top Mgmt. by IPADE. She currently leads the Inter-American Coalition for Regulatory Convergence, MedTech Sector.

Michelle is leading the International Pharmacovigilance organization at MSD. She has 25+ years of experience in the pharma industry and worked in clinical research and consulting prior to moving into pharmacovigilance (PV). Since joining MSD in 2002 she has performed various roles within PV including an EUQPPV support function, as well as prior regional operations roles in Asia Pacific and EMEA. Michelle has accountability for PV activities ex-US which consists of approx. 205 markets managed from 56 locations across the globe. Michelle is a part of the Global Clinical Safety and Pharmacovigilance Leadership Team, and works closely with HQ colleagues in the US. She is based in Europe.

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.

Dr Parellada, MD, PhD, Vaccine Outcomes Research Director for Latin America, works in the Center for Observational and Real-World Evidence of MSD. She is a healthcare professional with a demonstrated history of working in academic institutions and pharmaceutical industry. Her background includes active participation in planning and execution of pre-launching and life cycle management of products/ vaccines as part of cross-functional teams. Dr Parellada received her medical degree in 1993 and her “magna cum laude” PhD in Health Sciences in 2002 from São Paulo University (Brazil). She has authored more than 100 publications and support creation of F2F and e-learning courses, digital newsletters/ websites, and biomedical journal.

Vaishali Patadia, PhD, MPH, MBA is an Executive Director, Head of Signal Management and Risk Management Center of Excellence, Global Patient Safety in Amgen. She is also the lead for TransCelerate’s Rapid Signal Assessment using Real World Data workstream. Dr. Patadia has 22+ years of experience in pharmaceutical and biotech companies. She has a strong leadership track-record with broad experience across Patient Safety, including signal management, risk management, benefit-risk assessment and pharmacoepidemiology. She has extensive experience in leading change, building and growing global teams, mentoring, teaching, as well as in the design and implementation of innovative tools and processes in pharmacovigilance and pharmacoepidemiology.

Manager of Office for Quality Evaluation of Small Molecules (GQMED/GGMED) since october/2019. Previously manager of Office for Quality Evaluation for Registration of Small Molecules. Also acted as deputy General Manager of General Office for Small Molecules and Biologics in 2018 and assistant for Registration Directory at ANIVSA. Previus experience in analytical method development and validation, especially degradation products, and API manufacturers representation to brazillian pharmaceutical companies.

Tammy Steuerwald is the Head of Regulatory Policy for Foundational Principles and Supranational Organizations at Roche Diagnostics. In that role, she collaborates with the global regulatory community to identify modern and flexible solutions that drive improved access to innovative healthcare products. Her work includes efforts to support regulatory convergence, implementation of Good Regulatory Practices, and Regulatory Reliance policies and involves organizations such as the World Health Organization and IMDRF. Ms. Steuerwald holds a B.S. of Science from Indiana University, as well as a J.D. and Health Law Certificate from the Indiana University Robert H. McKinney School of Law.

Diana is a Medical Doctor with Master in Public Health from the University of Warwick in the UK and a Doctorate in Business Administration from the International School of Management in Paris (in course). Diana has held several regional leadership roles in Market Access across LatAm with various companies like Abbvie, Roche, Janssen and Baxter. She has experience in oncology, neuroscience and orphan diseases. In addition, she has in-depth experiences as Scientific Affairs Manager with Abbott, as Public Health Consultant with the Pan American Health Organization (PAHO) and served for 2 years as President for Latin American Consortium Health Technology with the International Society for Pharmacoeconomics and Outcomes Research (ISPOR).

I am a caregiver and former pharma R&D scientist, now building a start-up focused on helping EU Patient Organisations leverage data to increase their impact on healthcare change.

Pharmacist, Master in Clinical Epidemiology. Head of the Pharmacovigilance Subdepartment of the Public Health Institute (ISP). She has experience in the areas of pharmacovigilance, drug information, regulatory inspections, patient safety and evaluation of reference regulatory agencies.

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.

Dr. Kenneth J. Cavanaugh Jr. has been employed at the U.S. Food and Drug Administration Center for Devices and Radiological Health since 2003 and is currently a Deputy Director in FDA’s Office of Cardiovascular Devices. In this role, he is responsible for overseeing pre-market review, post-market surveillance, and compliance-related activities for all cardiovascular devices in the United States. Dr. Cavanaugh has also worked extensively in the areas of standards and guidance development and international harmonization, including co-leading several International Medical Device Regulators Forum (IMDRF) and ISO work items.

Juan Camilo Gonzalez is a Pharmacist with Master’s Degree in Science; he has extensive experience in pharmacovigilance country operations, policy, and systems management. He joined Moderna in April 2021 as Head of Pharmacovigilance operations Japan, APAC Countries, Africa and Latin America; now he is the Head of the Global Pharmacovigilance Operation at Moderna, he is located in Cambridge, Massachusetts, US.

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.

Pharmacist graduated in Federal University Of Minas Gerais (UFMG), Brazil, Specialist in Health Surveillance. Started in Anvisa (National Health Surveillance Agency) in 2005 on the marketing authorizations office. From 2011 to 2013 performed as advisor in the Anvisa's Board Of Directors. In 2015 was the manager of the Cells, Tissues, Blood, Organs Office then moved in 2016 to the Anvisa inspectorate. Since August 2022 is the Head of Biological Products and Advanced Therapy Medicinal Products Office.

Jan is a passionate and visionary leader in the field of pharmacovigilance, with over 20 years of experience in the industry. He is the CEO of iVigee, a company that provides innovative and sustainable solutions for drug safety and risk management. He is also a Fellow of the International Society of Pharmacovigilance (FISoP), a Global Fellow in Medicines Development (GFMD), and a Qualified Person for Pharmacovigilance (QPPV). Jan has a proven track record of establishing, growing, and selling successful organizations, both for-profit and non-profit, in the pharmacovigilance sector. He has received multiple awards and recognitions, including the DIA Excellence in Service Award in 2018 and HM Queen's Award for International Trade in 2019.

Bachelor in Biological Sciences (2001) and Master in Ecology from the University of Brasília (2005) and PhD in Tropical Medicine from the State University of Amazonas (2022). I worked at the Ministry of Health in the National Malaria Control Program between 2010 and 2018 and in the General Coordination of Arbovirus Surveillance in 2022. Between 2018 and 2022, I was a national consultant on malaria and I am currently a national officer on malaria and neglected infectious diseases at the Pan American Health Organization in Brazil

Erika Diago Rufino is a PhD candidate in Science with focus in E-labeling and Artificial Intelligence. Graduated in Pharmacy and Industrial Chemistry. Post graduated in Quality and Productivity, she also has an International MBA being a student in Cambridge and Bocconi. Black Belt certified in Lean Six Sigma. With extensive experience in the pharmaceutical, consumer goods and food industries, she has a 25-year career and has worked for companies such as Sanofi, Mars and J&J in the areas of Quality Control, Quality Assurance, Quality System and Operations. She is currently Director of Regulatory Affairs, in Janssen Pharmaceutical Brazil.

Meredith Smith, PhD, MPA, FISPE is Senior Director and Head, Implementation Science team within the Patient-Centered Research group at Evidera, Inc., PPD, a part of Thermo Fisher Scientific. She is a behavioral scientist and health services researcher by training with over 20 years of experience in health outcomes, drug safety and regulatory policy in the pharmaceutical industry. She has served on numerous FDA expert panels, on CIOMS Working Groups VIII, IX and XI, and IMI-PREFER and is an adjunct professor at the University of Southern California School of Pharmacy. She has been a pioneer in the application of Implementation Science methods within the context of drug development and has published widely in the peer-reviewed literature.

Pharmacist, MPH. Certified in Health Regulation and in Administrative Management at Public Organizations. Pharmacovigilance Manager at the Brazilian Health Regulatory Agency (Anvisa). She has expertise in the areas of drug information, health technology assessment, patient safety, economic regulation of medicines, and pharmacovigilance.

Omar is Acting Director of the Centre for Oncology, Radiopharmaceuticals and Research of the Biologic and Radiopharmaceutical Drugs Directorate (BRDD) at Health Canada. With over 18 years at Health Canada, Omar has experience as Manager of Cell, Gene Therapies and Radiopharmaceuticals Division and the Monoclonal Antibodies Division in BRDD. Prior to Health Canada, he served as a research scientist working on Alzheimer’s disease. Omar holds a Ph.D. in Pharmacology from the University of Paris VI, a Masters in Regulatory Affairs form the University of Montreal and a Master’s in Business Administration from University of Quebec. He completed a postdoctoral fellowship in the field of neurosciences at the Lady Davis Institute, McGill University.

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.

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.

Christine is a pillar of patient advocacy and allyship in the rare and chronic disease community. She is a champion for patient voices, diversity and inclusion in clinical research, and equitable patient-sponsor partnerships. As a patient, Christine has assisted in initiatives including MedicineX, the Stanford "Humanwide" Precision Medicine Program and the NIH All of Us Research Program; has served as board member and advisor for multiple non-profits and startup companies. She has been recognized as a 2019 100 Women of Influence by Silicon Valley Business Journal, 2020 Silicon Valley Community Hero, 2021 HIMSS Future50, and 2022 Medika Life 50 Most Influential Voices in healthcare.

Tim was one of the PhRMA expert working group (EWG) members on the ICHQ11 regulatory guidance document for drug substance, and the current Rapporteur for the ICHQ11 Starting Material IWG. He is also served on the ICHQ7 IWG Q&A team, ICHQ3C EWG, and supporting many other ICH efforts (such as Q12). Tim’s primary responsibility at Pfizer is to collaborate with Regulatory CMC team leaders, Co-Development teams (technical teams), and Pfizer Global Supply (PGS) teams from Small Molecule (API and DP), Biotherapeutics, Vaccines, etc. on a number of regulatory and technical issues.

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.

Experienced Medical Marketing Manager with a history of working in global, reginal and local teams in the healthcare industry in LATAM. A healthcare enthusiast, passionate patient advocate, I have recently specialized in helping patients by providing support in communication skills, resources, and guidance. With my knowledge of the industry, and personal experiences as a patient, I have helped patients get their voices heard in the industry. I have worked with organizations such as the FAST LATAM (Angelman Syndrome), Sickell Cell Disease, Rare Disease, among others. My latest work is a Voice of Patient Review, which is an FDA-led Patient-Focused Drug Development (PFDD) Report, where the FDA recognizes the value of gathering patient input.

Experiencia Académica. Medico y Cirujano, Master en Salud Publica, Gestion de Calidad, Gestión de Riesgos, Regulación Sanitaria de Productos Biológicos. Experiencia Laboral. Asesor, Fortalecimiento de Sistema Regulador de Medicamentos y otras Tecnologias Sanitarias. mayo 2018 a la fecha Director Nacional de Medicamentos, abril 2012 - abril 2018.

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.

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

Eva Maria Ruiz de Castilla Founder and director of LAPA (Latin America Patients Academy) has more than 20 years of experience providing strategic leadership, development and global health policy analysis and implementation. She is a global leader in patient-based organizational capacity building, patient involvement and alliance development covering several therapeutic areas, including cancer, NCDs and rare diseases. She is expert in health diplomacy, organizing forums and building coalitions of patient groups, physicians, public health specialists and government officials to generate dialogue and action plans to address a variety of public health issues.

As Pharmacist and Specialist in Health Surveillance and Regulation, I'm working at Anvisa since 2005. I had expertise in some medicine areas, like market authorization, traceability and authenticity, regulation of inserts and labels, etc. In 2016, I began work with Pharmacovigilance in activities related to the ICSRs management system, including the implantation of VigiFlow in Brazil with the partner of Uppsala Monitoring Centre (UMC), and the uses of PV databases. I'm representing Anvisa in the following Working Groups: ICH WG E2B (R3), ICH WG E2D(R1), and CIOMS WG XI on Artificial Intelligence in Pharmacovigilance.

Dr Samvel Azatyan is a Paediatrician with a PhD in clinical pharmacology and medical products regulation. Over his more than 24 years at WHO, he has had a wide range of leadership roles associated with the regulation of medical products, including supporting regulatory collaboration, convergence and harmonization, as well as regulatory capacity building and facilitation of products introduction in the countries. Dr Azatyan has also led various projects aiming at development of national regulatory systems, as well as the development and implementation of the concept of reliance in regulation of medical products. Dr Azatyan is currently leading the Regulatory Convergence and Networks Team at the WHO's Headquarters in Geneva, Switzerland.