Director of Evaluation and Control of Biologic and Radiopharmaceutical Products-ANMAT. She studied biochemistry at the Buenos Aires University where she was assistant professor and researcher of the Biochemistry and Pharmaceutical Industries career. She has technical background for more than 25 years in regulatory science with emphasis in research, control and evaluation of biologic and radiopharmaceutical products. She coordinates the Sub-Committee for Biologic Products, Argentine Pharmacopeia. She is member of the Interministerial Commission on Advanced Therapies and she has participated as member of severals programs of the Ministry of Science Technology and Productive Innovation.

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.

Maria has 30+ years of Pharmaceutical industry experience mainly in Quality.With Pfizer since 1991; she managed analytical laboratories, including the Quality Control Laboratories, and was the Brooklyn Site Quality Operations Director prior to assuming a Center position. Current, she is responsible for developing strategies to address emerging regulations and guidance documents in the areas of GMPs and pre- and post-approval filings (Chemistry Manufacturing and Control, CMC), and assisting in development of company positions and responses to proposed regulations and guidances. Her focus is mainly US and Latin America. She holds a degree in Pharmacy from the University of Buenos Aires and a PhD in Organic Chemistry from New York University.

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

Pharmacist with more than years working in Regulatory Affairs specialized in Medical Devices on multinational companies. Wide experience working in policies that enable patients have access to the best technologies.

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.

Carlos Pinoargote is the Chief Operating Officer at BRCR Global. BRCR is a Contract Research Organization for the Pharmaceutical Industry; he has been with the company since the early days of incorporated, 11 years ago. BRCR is actively working in the Latin American region, providing different solutions and Regulatory Approval services for different Sponsors. Carlos's role is to make sure BRCR's staff and operation comply with policies and processes, assigning resources and creating milestones to exceed Sponsor's expectation in the approval process of new treatments and medicines.

Ana has over 19 years of pharmaceutical industry experience starting in Analytical Development (2-year) and then Regulatory Affairs area by working for Medley (Brazil), Novartis (Brazil and Switzerland), Parexel (Brazil) and in the last 8+ years for Roche leading the CMC Regulatory Policy activities for Latin America (Brazil and Uruguay). Ana is currently working since January 2019 as Associate Director at Merck Serono in CMC Regulatory Intelligence team in Switzerland. Ana holds a Biochemistry and Pharmacy Bachelor’s Degree at Sao Paulo Public University (USP) and a Master Degree in Pharmacology with focus on bioequivalence studies at Campinas Public University (UNICAMP).

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

Renata is pharmacyst with more than ten years of experience in Regulation and Health Surveillance. Graduated from the University of Brasilia in Pharmaceutical Sciences, post graduated in Forensic Sciences and specialized in Principles and Practices of Clinical Research (PPCR) by Harvard University. Experience in multiple areas of regulation and health surveillance such as Economic Regulation of Medicines, Therapeutic Equivalence, Assessoring oF Anvisa Director’s Board and others. She is Health and Regulation Expert from ANVISA and works in the present as Safety and Efficacy Assessment Manager for synthetic medicines in the Agency.

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 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.

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.

Vice President, Pfizer Global Supply (PGS), New Modalities New Product Lead Pamela Siwik As the New Modalities New Product Lead, Pam is responsible for development and execution of Pfizer’s manufacturing and supply strategies for gene therapy, mRNA and other new modalities that Pfizer is exploring. Pam earned her Bachelor’s degree in Chemical Engineering from the University of Michigan in Ann Arbor, MI, as well as her Master of Business Administration (MBA) from the Stephen M. Ross School of Business, at the University of Michigan.

Aimad Torqui has been the Division Head at the Medicines Evaluation Board since September 2022. His role encompasses overseeing (national)policy and European affairs, regulatory science, representation in EU committees, promoting the better use of medicines and veterinary medicines.

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.

Márcia Gonçalves de Oliveira-Pharmacist, Specialist in public health, specialist in regulation and sanitary surveillance by FIOCRUZ, Master in sanitary surveillance by the Federal University of Bahia (UFBA), Master in Public Administration by Fundação Getúlio Vargas (FGV). ANVISA’s employee since 2005, currently is the coordinator of the area of Package Inserts, Labeling, Simplified Registration and Commercial Name of Medicines (CBRES/ANVISA).

Dr. McKee worked for over 10 years at the U.S. Food and Drug Administration most recently in the role of Deputy Center Director, Oncology Center of Excellence (OCE) and Supervisory Associate Director, OHOP, CDER. Dr. McKee was the signatory authority for products within Office of Hematology and Oncology Products (OHOP), Center for Drug Evaluation and Research (CDER). She was responsible for four Divisions performing the scientific review and evaluation of hematology and oncology therapeutic drugs and biologics subject to regulation by CDER. Dr. McKee has experience in managing, developing and implementing the multi-disciplinary reviews for marketing applications (NDAs & BLAs) within OHOP. She managed international regulatory program with

Dr Saint-Raymond is a French paediatrician. In 1995, she joined the French Medicines Agency, and in 2000 she joined the EMA where she was the Head of Special Areas (Paediatrics, Orphan Drugs, Scientific Advice, SME Office and Scientific Projects). She implemented the European Orphan Drug Regulation then the Paediatric Regulation. She has been an expert for the European Commission, the European Developing Countries Trial Partnership, the Canadian Council of Academies, and the US National Academies of Science, Engineering and Medicine, a member of the UN Commission on Life-Saving Commodities for women and Children and Associate Prof of Paediatrics at Tor Vergata University Rome.

John Scott is Director of the Division of Biostatistics in the FDA's Center for Biologics Evaluation and Research, where he has also served as a statistical reviewer for blood products and for cellular, tissue and gene therapies. He holds a Ph.D. in Biostatistics from the University of Pittsburgh, an M.A. in Mathematics from Washington University in St. Louis, and a B.A. in Liberal Arts from Sarah Lawrence College. He is a Fellow of the American Statistical Association and a past Editor of the journal Pharmaceutical Statistics.

Jennifer has 25+ years of experience in the pharmaceutical industry, and 20 years of experience in QA. Jennifer is the BioTherapeutics Quality Assurance Director at Pfizer and leads a team responsible for Quality oversight of assets in Phase 1 through commercialization. Most recently, Jennifer has also been the Quality lead for the COVID-19 Vaccine for Pfizer.In 2001, Jennifer joined the Pfizer Quality Assurance team supporting BioTherapeutics in the Pfizer pipeline. Jennifer began her career in pharmaceutical sciences working on non-clinical and clinical research in the field of ophthalmology, including allergy and immunology, glaucoma, and dry eye syndrome.

Anders Vinther, Ph.D, has established and grown companies, merged organizations, led Quality functions as Chief Quality Officer, chaired organizations and programs, and led culture change at large and small scale. Anders has more than 30 years work experience in the pharmaceutical industry and is currently co-leading the One-Voice-of-Quality for Post Approval Changes (1VQ on PAC) Initiative which is sponsored by the Chief Quality Officers of the 25 largest pharma companies. The initiative is focused on reducing drug shortages and enhance innovation and continual improvement globally.

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.

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.

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.

Rebecca is a Director in the Pfizer Global Regulatory Policy and Intelligence group. Focus areas include expedited and reliance approval pathways, regulatory system strengthening and evolving standards of evidence especially in International regions. Prior to joining Pfizer in 2017, she was Head of Science Policy at the UK Trade Association (ABPI) and has worked on numerous policy issues relevant to the biopharmaceutical industry during her 8 years there. She is a Co-Chair of the FIFARMA’s Regulatory and Biologics Working Group and a member of the Expedited Pathways group in EFPIA. She was a post-doctoral scientist prior to her career in policy, with a PhD from Fitzwilliam College, University of Cambridge (UK) in cell signalling.

Sylvie has been engaged in regulatory policy activities for 20 years, through positions in Brussels trade associations, including EFPIA. She joined MSD as Director Global Regulatory Policy in June 2015, where she is now Global CMC Policy Director. Sylvie’s expertise and knowledge of the European pharmaceutical environment serves to drive regulatory policy activities in the areas of CMC and Quality in the EU and globally. Sylvie also co-leads the IFPMA Manufacturing & Quality Group policy activities. Sylvie holds a Maîtrise in Biochemistry from the University of Bordeaux II and a Diploma from the University of Kent at Canterbury.

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.

Current position: Head of Clinical Trials Department at Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT), Argentina. Joined ANMAT in 2012 to evaluate Clinical Pharmacology Trials of different pathologies. Since 2018, coordinates the Clinical Trials Department and is member of ANMAT's Multidisciplinary Innovation Support Team.Graduated as Medical Doctor from the University of Buenos Aires. Pediatrician with a Pediatric clinic residency held at Pedro de Elizalde Children's General Hospital in Buenos Aires. Magister in Clinical Pharmacological Research, with a degree awarded by the Universidad Abierta Interamericana. Currently, finishing the specialty of Clinical Pharmacology at the University of Buenos Aires.

Dr. Wissink joined Regulatory Affairs Europe MSD in January 2014 to lead the company’s oncology efforts, including the registration of the PD-1 inhibitor, Keytruda® as well as its developmental activities. Prior to joining Regulatory Affairs Europe, Dr. Wissink was Director, Global Regulatory Affairs at MSD responsible for Alzheimer’s Disease development. Dr Wissink started her career in Industry in Regulatory Affairs in Organon in 1999, and held different positions of increasing responsibility within Organon, Schering-Plough and MSD. Dr. Wissink received her PhD in Molecular Biology from the University of Utrecht. Prior to joining industry, she held the position of Postdoctoral Fellow at the Hubrecht institute, Utrecht, the Netherlands.

Nicole Ennis is the Head of the Medicines Quality Control and Surveillance Department, the Jamaica campus of the Caribbean Public Health Agency. She has extensive experience in the implementation of laboratory quality and safety systems from her previous role as Quality/Safety Manager. She holds a BS Biology from Yale University and an Erasmus Mundus MS Quality Management of Laboratories from Gdansk University of Technology. Nicole is responsible for the management and maintenance of the Department’s ISO/IEC 17025 accredited testing services for medicines to verify their quality and efficacy. She also leads the Department in its collaborative work with regional partners to develop and strengthen policies for medicines regulation.

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.

General Manager of Medicines and Biological Products at ANVISA, Brazil. Responsible for the management of drug and biological product registration submission evaluation teams, authorization to conduct clinical trials in Brazil, and certification of bioequivalence centers. I have been working at ANVISA, Brazil since 2003 mostly with bioequivalence / biowaiver studies and clinical trial evaluations. I'm a pharmacist with specialization in public health, I also holds a Master of Toxicology.

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.

Joerg has about 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 and EFPIA. As global Policy Lead, he co-/authored several publications and industry positions on in-country testing and Advanced Therapy Medicinal Products (ATMPs). Joerg received a PhD in biochemistry from the University of Hannover/Max-Planck-Institute of Biochemistry, Germany.

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.

Telba is Senior Scientific Director in Quantitative Sciences at Janssen R&D. She comes from FDA where she pioneered the use of Bayesian statistics and wrote several guidance documents. She received the FDA Excellence in Analytical Science Achievement Award for spearheading innovative regulatory science studies culminating in the release of novel guidance documents, supporting complex policy decision making and changing the submission review paradigm. Recently at the Center for Biologics, her portfolio expanded to include the Science of Patient Input, Complex Innovative Designs, and trials for rare diseases. She received a PhD from Berkeley, is fellow of the American Statistical Association and member of International Statistical Institute.

Industrial Pharmacist, graduated from the Pedro Henríquez Ureña National University, Dominican Republic, Master in General Treaty of Biopharmacy and Pharmacokinetics of EUROINNOVA, I have several diplomas and courses in Regulatory Affairs for the Evaluation of Biological Products and Biotechnology, Auditor in ISO 9001, GMPx , negotiator of Central American Technical Regulation, among others. My professional experience has been developed for more than 20 years within the Pharmaceutical Industry in areas of production, quality management systems, as well as consulting for the construction and installation of pharmaceutical industries in Central America, in the last decade I have ventured into the Regulatory Affairs area by the government.