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.

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.

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

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 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.

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.

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

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.

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

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.

Pedro holds a degree in Pharmaceutical Science (PharmD), a Master in Organic Chemistry from the University of Lisbon in collaboration with Imperial College in London and a PhD in Orphan drugs and Rare diseases from the University of Sheffield. Currently, he is working as a Director for Global Regulatory & Scientific Policy at Merck, mainly focus on regulatory intelligence, strategy and policy. He is the liaison for the China and Latam region concerning regulatory and policy topics. Previously, he worked at EMA for 12 years in different departments (regulatory affairs, assessment, authorisation of medicines, veterinary, orphan drugs, paediatrics, peer review and quality). Beforehand, he was working at INFARMED as a pharmaceutical assessor.

Nathan A. Carrington (Nate) is the Head of Digital Health and Innovation for the Global Regulatory Policy and Intelligence team at Roche Diagnostics, located in Indianapolis, USA. In this role, Nate collaborates with internal and external stakeholders to develop and execute strategies related to a number of regulatory policy initiatives. His current areas of focus include Digital Health-related topics such as software qualification, SaMD classification, software clinical evidence requirements, requirements for AI-Based SaMD products, and Real World Evidence. Nate received his Ph.D. in Analytical Chemistry from the University of Tennessee and began work at Roche Diagnostics in 2007 as a Principal Scientist.

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.

After training at UCSF, Georgetown University and NIH and years of practice in Internal Medicine and Endocrinology, Dr. Irony joined FDA CBER in 2000 as a clinical reviewer. He also worked in the Endocrine Division in CDER as a reviewer and team leader. In 2011, he returned to CBER first as branch chief, and then became Deputy Director in the Division of Clinical Evaluation and Pharmacology / Toxicology in the Office of Tissues and Advanced Therapies. In 2018 he was detailed as director of the Office of Orphan Products Development, and in 2020 as Deputy Director of the Office of Cardiology, Hematology, Endocrinology and Nephrology. In 2021, he joined Janssen R&D as Senior Director, Global Regulatory Leader with a focus on gene therapies.

Connie Langer is a Senior Director at Pfizer who leads a team that monitors and advises on regulatory changes and impacts. She collaborates with experts to communicate Pfizer's feedback and position to health authorities on regulations and guidance documents. She also has experience implementing science- and risk-based approaches and recommending strategic regulatory options to achieve product approvals globally. She is a member of the ISPE PQLI® ICH Q12 Working Team and chair of the IQ ICH Q12 Working Group. She holds BS in Chemical Engineering and an MS in Chemical Oceanography both from the University of Connecticut, and a Drug Development Certificate from Temple University.

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.

+20 years’ of experience working in both the public & private sector of Regulatory Affairs (RA). Her career started at the MHRA - the UK RA & then moved into UK & EU regulatory strategy roles at both AZ & then Pfizer. In each of these roles she gained valuable experience across multidisciplinary aspects of RA ranging from Strategy, Labelling, CMC, Submissions, Artwork to Clinical Trials. In 2009, Ronnie moved into Labeling, managing diverse roles within Global & Regional functions at Pfizer. Ronnie’s responsibilities have included projects spanning labeling activities across EUCANZ, EME, AfME, Canada &LATAM. Currently a key focus for Ronnie is internally & externally leading on the topics of health literacy and ePI across LATAM, AFME, EU.

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.

Peter Stein, MD, is the Director of CDER’s Office of New Drugs (OND). OND is responsible for the regulatory oversight of investigational studies during drug development and decisions regarding marketing approval for new (innovator or non-generic) drugs, including decisions related to changes to already marketed products. OND provides guidance to regulated industry on a wide variety of clinical, scientific, and regulatory matters. A nationally-recognized leader in pharmaceutical research and development, Dr. Stein joined CDER in 2016 as the OND Deputy Director. Before coming to FDA, he served as Vice President for late stage development, diabetes, and endocrinology at Merck Research Laboratories.

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.

Regulatory Affairs Expert at Saudi_FDA with a demonstrated history of working in the pharmaceutical industry . Member of ISO Committees. Skilled in Pharmaceutics, Pharmacovigilance, Healthcare, Clinical Research, and Regulatory Affairs. Strong quality assurance professional with a Master's degree focused in Pharmaceutical Sciences from King Saud University.

Miriam Fuchs is a Global Therapeutic Area Lead in Regulatory Affairs at Novartis. Passionate about bringing innovation to patients, over the past years she has focused on CAR-T therapies, including the development registration of Kymriah. Miriam has worked in Project Management and Regulatory Affairs at Novartis as well as other Pharma/Biotech companies for 20 years. She holds a PhD in Biology from the Max-Planck Institute and engaged in cancer research as a post-doctoral fellow at the Dana-Farber Cancer Institute, Harvard Medical School, Boston, USA prior to joining industry.

Martin Harvey is Head of International Affairs at the European Medicines Agency (EMA), EU. He first joined the EMA legal team after serving as a European affairs consultant in Brussels. He headed the Office of the Executive Director, served as Head of Communication, and then moved to the Agency's International Affairs team. He took an 18-month career break with Unitaid, the WHO-hosted partnership dedicated to innovation in global health from 2019-2020. Martin has served on the DIA Advisory Council for EMEA; and as program advisor for DIA's EuroMeeting and Global Annual Meeting. He holds law degrees from the University of Dundee (UK) and the Vrije Universiteit Brussels (Belgium). He is a Fellow of DIA since 2018.

Rutendo is leading the Incidents and Substandard/Falsified (ISF) medical products team at the World Health Organization (WHO) since June 2021. The ISF team is part of the Regulation and Safety (REG) Unit of the Regulation and Prequalification (RPQ) department that is within the Access to Medicines and Health Products (MHP) division. He has been based at the WHO HQ in Geneva, Switzerland since January 2009. Since joining WHO he has held various roles including being responsible for the initiation, coordination and conduct of activities related to prequalification of medicines quality control laboratories in priority regions and countries. He was also involved in provision of technical assistance and capacity building for quality control.

Stephan works in Quality External Affairs at Amgen on Operations/CMC since 2013. He collaborates cross-functional internally and with external stakeholders by shaping regulatory guidelines, disseminating intelligence, and educate. He represents Amgen in EFPIA MQEG and represents EFPIA on GMPs/inspections, in ICH training and ICH-QDG and before on ICHQ9, ICH Q-IWG and ICHQ7-IWG. In PDA he was at the board and chaired RAQAB.

Dr St John rose in the ranks of Public Health in Barbados from 1994 to become the first Barbadian Chief Medical Officer of Barbados in 2005. She represented Barbados on the Executive Board of WHO, becoming the first Caribbean chairperson of the Executive Board in 2012-2013. In 2017 she became Assistant Director General at the WHO HQ in Switzerland. She held the Portfolio of Climate and Other Determinants of Health and completed the first phase of the Climate Change and Health SIDS Initiative. In July 2019 she became Executive Director of the Caribbean Public Health Agency. CARPHA led the CARICOM regional public health response to the COVID-19 pandemic. Her leadership has seen her engage about COVID-19 with sectors in and outside of CARICOM.

Dr.Witten holds an undergraduate degree in math from Princeton University and a Ph.D. from Stanford. She attended medical school at the University of Miami and completed her residency in Physical Medicine and Rehabilitation at the Hospital of the University of Pennsylvania. She practiced medicine at the National Rehabilitation Hospital in Washington DC and has held several positions at FDA, currently serving as the Office Director of OCTGT in CBER.

Bruno leads AbbVie's Latin America Regulatory Affairs team, with responsibility for managing regulatory applications across 23 markets. Prior roles have included leading the regulatory portfolio management team as well as integration activities for M&A transactions. Prior to AbbVie, Bruno worked for Deloitte Consulting, Capgemini, and Ernst & Young, where he provided consulting services for biopharma and healthcare organizations. His experience spans R&D and Commercial functions, including Regulatory Compliance, Development Operations, and Contract Management & Government Pricing. Originally from Paraguay, Bruno has lived in the US for 25+ years. He holds an MBA from the University of Oxford and an engineering degree from Purdue University.

Head of Anvisa's International Affairs Office since March 2020, is a career diplomat who served at diplomatic missions in Lima (Peru) and Montevideo (Uruguay). At the headquarters of the Ministry of Foreign Affairs, he held, among others, the position of deputy head of the MERCOSUR Economic Division, when his responsibilities included coordinating the efforts related to regulatory convergence within MERCOSUR.

Brandon D. Gallas provides mathematical, statistical, and modeling expertise to the evaluation of medical imaging devices at the FDA. His main areas of research are image quality, computer-aided diagnosis, imaging physics, and the design, execution, and statistical analysis of reader studies ([https://github.com/DIDSR/iMRMC/releases], https://cran.r-project.org/web/packages/iMRMC/index.html). Recently, he has been investigating pathologist performance and agreement using whole slide imaging devices and the microscope (https://ncihub.org/groups/eedapstudies). Dr. Gallas also participates in the Pathology Innovation Collaborative Community (https://digitalpathologyalliance.org/), a regulatory science initiative.

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.

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.

Pharmaceutical Chemist graduated from the Universidad Nacional Mayor de San Marcos in Lima-Peru, with 48 years of experience in the Pharmaceutical Industry in the areas of Quality Assurance, Quality Control and Production, Quality Audits and Technical Advice to Pharmaceutical Laboratories, and Training Staff on technical issues related to the pharmaceutical profession. To date I work as Executive Director of Pharmaceutical Products of DIGEMID (Ministry of Health of Peru). I have held positions such a Technical Director, Quality Assurance Manager, Quality Director, Industrial Sales Management, Implementation of GMP and ISO 9000, General Manager, Quality Coordinator and Assistant Professor in Peru, Colombia and Venezuela.

João Batista Silva Junior, MHS, has been working at ANVISA, Brazil since 2005 with regulation of blood, tissue, cells and organs for therapeutics uses. He is the manager of the Blood, Tissues, Cells, Organs Office (GSTCO) at the Anvisa/Brazil. GSTCO is responsible for assuring the safety, quality and efficacy of blood, cells, tissues and advanced therapies products and services. Hes is Ph.D student in pharmaceutical and biotechnological sciences, conducting on risk and benefit research in advanced therapy products.

Patrick Celis joined the European Medicines Agency (EMA) in 1997. He holds a degree in Pharmacy and a PhD in Pharmaceutical Sciences. P Celis is Lead Scientific officer in EMA’s ATMP Office and since December 2008, he is responsible for the Scientific Secretariat of the Committee for Advanced Therapies (CAT). P Celis held previous positions in EMA, including the coordination of EU authorisation procedures for biological/biotech products. He was responsible for the following scientific projects: Pandemic influenza vaccines, TSE, viral safety of recombinant products and cell-based medicinal products. He held the positions of Scientific Secretary of the Vaccine Working Party and the Cell-based Products.

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.

Regional advisor on pharmaceutical policies and innovation, PAHO/WHO. He has a degree in economics (National University of La Plata, Argentina) and a master's in health policy and management, Europe-Latin America (University of Bologna, Italy). Previously, he served as coordinator of the medicine and health technology unit at PAHO/WHO in Brazil, director of health economics at the Argentine Ministry of Health, coordinator of the Technical Group on Universal Access to Medicines of the Union of South American Nations, consultant at the Secretariat of Science and Technology of Argentina and researcher/postgraduate professor at ISALUD University (Buenos Aires).

BSc Pharmacy at the Complutense University of Madrid. Master of Development, registration and regulation of medicines in the European Union (Autonoma University of Barcelona) and Master of Pharmacoeconomics and Market Access (Carlos III University of Madrid). Working at the AEMPS since 2005 and up to now: firstly linked to the coordination of centralised procedures at national level, then in tasks related to market access (therapeutic positioning reports) and currently involved in duties related to the Regulatory Affairs Division.

Angelika Joos is a trained pharmacist. She is responsible for Regulatory Policy issues within MSD's Global Regulatory Affairs and Clinical Safety department. This role includes identifying regulatory policy priorities that align with MSD’s business priorities, leading cross-functional networks to define policy positions, and informing MSD’s regulatory strategy development. Angelika represents MSD in the IFPMA Regulatory Science Committee and is one of IFPMA's delegates to the ICH Management Committee. She is also involved in international policy activities though efpia as well as BIO and PhRMA international Committees. She served on the DIA Board of Directors from 2013-2020.

Sam leads several global regulatory teams in developing strategy for bringing mRNA-based respiratory vaccines to the market. He has 10 years of experience in regulatory affairs, including CMC, Ad/Promo, clinical, and HA interactions. Sam led the Sanofi Pasteur contributions to the WHO Guidance on mRNA vaccines and participated in the WHO informal consultation held by the ECBS in April 2021. Sam is a molecular biologist by training, with a Master of Science degree from Michigan State University.

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.

Celia Lourenco, PhD has been the Director General of the Biologic and Radiopharmaceutical Drugs Directorate (BRDD) of the Health Products and Food Branch of Health Canada since November 2018. She was previously the Senior Executive Director of the Therapeutic Products Directorate (TPD) and held other management positions within TPD over a period of about 10 years. In her various management roles, Celia has been responsible for the review and authorization of a variety of new drugs for human use, either for clinical trials or for market authorization in Canada. Celia has contributed to international initiatives such as ICH and IPRP, she co-chairs the ICMRA COVID-19 working group and participates on DIA's Council of Regulators.

Katherine (Katie) Serrano is the Director of the Latin America Office in FDA’s Office of Global Policy and Strategy (OGPS). Before assuming this role in 2017, Ms. Serrano served nine years in the Office of In Vitro Diagnostics and Radiological Health in FDA’s Center for Devices and Radiological Health’s Office of In Vitro Diagnostics and Radiological Health (CDRH). While at CDRH, Katie worked as a scientific reviewer, as the Diabetes Diagnostic Branch Chief and the Deputy Director of FDA's Division of Chemistry and Toxicology Devices. She also served as the technical and policy lead for the Agency’s efforts related to Laboratory Developed Tests.