Latin America Regulatory Conference
Patricia Aprea, MD
- Director, Evaluation and Control of Biológicals/Research
- ANMAT, Argentina
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.
Cammilla Horta Gomes, MA
- LATAM Regulatory Policy Lead
- Roche, Brazil
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 and industry, leading or contributing to bilateral and multilateral negotiations, harmonization and convergence initiatives. Specialized and policy activities include: working within WHO, PAHO, Mercosur, ICH, IPRP, IMDRF, ICMRA, UNODC, and industry associations; liaising with government agencies, industry and other stakeholders in the area of health regulation; organization of and institutional representation in information sharing events. Currently working in Roche as a Regulatory Policy Lead for Latin America.
Maria Guazzaroni Jacobs, PhD
- Director, Quality and Regulatory Policy (QRP), Global Supply
- Pfizer Inc, United States
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.
Fernanda Lessa, MBA, MPH
- Reg Affairs Specialist, Health Systems/Services and Medicines and Health Tech
- Pan American Health Organization (PAHO), United States
- LatAm Regulatory Affairs Policy Manager
- Novartis, United States
Roberta Mele Mazza, RPh, RAC
- Q&RA Manager, División Diagnóstica
- Productos Roche , Argentina
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.
Maria Cristina Mota Pina, MBA
- Director, Regulatory Policy and Intelligence -Japan, Emerging Markets, Australia
- AbbVie, Inc., United States
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.
- Chief Operating Officer
- BRCR, United States
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 Padua, MSc, RPh
- Associate Director GRA CMC Regulatory Intelligence Biopharam Global Regulatory
- EMD Serono, Switzerland
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 Semprun, RPh
- Director, Global Regulatory Policy - Latin America
- MSD, Panama
Leonardo Semprún is currently Director, Global Regulatory Policy for Latin America at MSD, based in Panama. 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. Prior to this role, Leonardo served as Regional Regulatory Affairs Liaison for Latin America. During this role he lead a team responsible for the development of the regulatory strategies for Vaccines, Anti-Infective, and Hospital Acute Care products. He has worked with governments, regulators, trade bodies and other external stakeholders to shape regional regulatory policy.
Renata De Lima Soares
- Regulation and Health Surveillance Specialist
- Anvisa, Brazil
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 Viejobueno, LLM
- Latin America Lead, Global Regulatory Policy and Intelligence
- The Janssen Pharmaceutical Companies of Johnson & Johnson, Argentina
Sonia has over 15 years of professional legal, health policy and regulatory policy experience in the Latin American biopharmaceutical industry. As legal counsel specialized in commercial, business and corporate law, she has provided extensive legal advice to pharmaceutical companies in the region, including pharmaceutical law, intellectual property, business transactions, regulatory matters and corporate healthcare compliance, among others. She joined Johnson & Johnson in 2016 as Latin America Lead for Global Regulatory Policy & Intelligence. 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.
- Coordinadora de Seguridad y Eficacia
- DIGEMID, Peru
- Dirección Nacional de Vigilancia Sanitaria, Paraguay
Ana Patricia Pineda, MSc
- International Regulatory Analyst, OIP, OGROP, OC
- US FDA, Mexico
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 new cooperation instrum
Pamela Siwik, MBA
- Vice President, Pfizer Global Supply Rare Diseases and New Modalities and New Pr
- Pfizer Inc., United States
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.
- Executive Director Global Regulatory Policy
- MSD`, Netherlands
Aimad Torqui is Director of Global Regulatory Policy at MSD. Previous employment. He has worked with governments, regulators, trade bodies and other external stakeholders to shape robust science-based regulatory policy.
Samvel Azatyan, MD, PhD
- Team Lead, Regulatory Convergence and Networks (RCN/REG)
- World Health Organization (WHO), Switzerland
Dr Samvel Azatyan is a Paediatrician with a PhD in clinical pharmacology and medical products regulation. Over his more than 20 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 De Oliveira
- Coordinator of Package Insert, Labeling, Simplified Registration and Trade Name
- Agência Nacional De Vigilância Sanitária, Brazil
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).
Amy McKee, MD
- Vice President, Regulatory & Access
- Parexel International, United States
Dr. McKee worked for over a decade the in 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
Agnès Saint-Raymond, DrMed
- Head of Division International Affairs
- European Medicines Agency, Netherlands
Agnes is an MD and qualified French Paediatrician. She worked as a paediatrician in a paediatric Hospital in Paris, France, then in pharmaceutical industry, and then moved to the French Medicines Agency. In 2000 she joined the European Medicines Agency (EMA) and was responsible for Orphan Medicines, Scientific Advice, the Small & Medium-sized Enterprises Office, and Paediatric Medicines Sector, implementing the EU Regulation on paediatric medicines. In 2013, she became Head of the Portfolio Board Division, providing oversight of projects for EMA. Since November 2016, she is also the EMA Head of the International Affairs Division.
John Scott, PhD, MA
- Director, Division of Biostatistics, OBE, CBER
- FDA, United States
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 Deputy Director and as a statistical reviewer for blood products and for cellular, tissue and gene therapies. He has authored or co-authored numerous articles in areas including Bayesian and adaptive clinical trial design and analysis, drug and vaccine safety, data and text mining, and benefit-risk assessment. 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, and is a Fellow of the American Statistical Association.
Jennifer E. Sloan, MS
- Director, PSQA BTx Portfolio, Pfizer Global Supply
- Pfizer Inc., United States
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, PhD, MSc
- QBA, United States
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 Katherin Zavala Coloma, RPh
- General Directorate of Medicines, Supplies and Drugs
- DIGEMID, Peru
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 6 years at DIGEMID, she has work as a quality 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 and PAHO. Currently, she is the coordinator of the reviewer team of biological products.
Rian Marie Extavour, PhD, MSc, RPh, RAC
- Technical Coordinator, Caribbean Regulatory System
- Caribbean Public Health Agency (CARPHA), Trinidad And Tobago
Dr. Rian Marie Extavour is a pharmacist by training, and is the Technical Coordinator of the Caribbean Regulatory System (CRS), under the Caribbean Public Health Agency (CARPHA). Dr. Extavour holds Master of Science degrees in Clinical Pharmacy, and in Pharmacovigilance and Pharmacoepidemiology, as well as a Doctor of Philosophy degree. She oversees the technical work of the CARPHA-CRS, which supports CARICOM Member States in regulatory functions of market authorization and pharmacovigilance. Her work experience includes pharmacy education, research, consulting in pharmaceutical systems and medicines utilization, and pharmacovigilance.
Lawrence Liberti, PhD, RPh, RAC
- Adjunct Assistant Professor
- Temple University School of Pharmacy, Reg. Affairs and QA Grad Program, United States
Dr Liberti has worked in pharmaceutical regulatory affairs, communications and clinical R&D for the past four decades. Since 2009 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 Lumsden, PhD
- Director, Regulatory Policy and Intelligence
- Pfizer Inc, United Kingdom
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 Advanced Therapies Working Group in IFPMA. 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 Meillerais, MSc
- Director Global CMC Policy
- MSD (Europe) Inc., Belgium
Sylvie has been engaged in regulatory policy activities for close to 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. She is an active member of the EFPIA Manufacturing and Quality Experts Group and of the Middle East network, where she leads the Life Cycle Management efforts. She is further engaged in IFPMA CMC & Quality policy activities. Sylvie holds a Maîtrise in Biochemistry from the University of Bordeaux II.
Erika Rufino, MBA
- Regulatory Affairs Senior Manager
- Janssen Pharmaceuticals, Brazil
Erika Diago Rufino is a Doctoral Student in Science with focus in E-labeling, has a degree 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 Senior Manager of Regulatory Affairs, in Janssen Pharmaceutical Brazil, and is also responsible for International GMP Inspections and the Analytical Development Laboratory for New Products.
Laura Giselle Traversi, MD
- Head of Clinical Trials Department
- ANMAT, Argentina
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.
Sacha Wissink, PhD
- Executive Director, Regulatory Affairs Europe
- MSD, Netherlands
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.
Carlos Junio Falconí Borja
- Director Técnico de Elaboración, Evaluación y Mejora Continua de Normativa
- Argencia Nacional de Regulacion, Control Y Vigilancia Sanitaria (ARCSA), Ecuador
Nicole Ennis, MSc
- Head Medicines Quality Control and Surveillance Department
- Caribbean Public Health Agency, Jamaica
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.
- Executive Secretary,Inter-American Coalition for Regulatory Convergence
- Advanced Medical Technology Association (AdvaMed), United States
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.
Gustavo Mendes Lima Santos, MPharm
- General Manager of Medicines and Biological Products
- ANVISA, Brazil
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.
Raphael Sanches Pereira
- Health and Regulation Expert / Office Manager
- ANVISA, Brazil
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.
- Vice President - Global Strategy and Analysis
- Advanced Medical Technology Association (AdvaMed), United States
Joerg Garbe, PhD, MSc
- Global Quality Manager & Policy Lead
- F. Hoffmann-La Roche Ltd, Switzerland
Joerg has 15+ years of experience in the pharmaceutical industry within different functions in the quality field. He serves as Global Quality Manager & Policy Lead in Roche Pharma Global Technical Operations overseeing Roche’s global in-country testing activities. He co-/authored several publications and positions on local re-testing. Joerg received a PhD in biochemistry from the University of Hannover/Max-Planck-Institute of Biochemistry.
- Instituto de Salud Pública de Chile, Chile
Telba Irony, PhD, MS, MSc
- Senior Scientific Director, Quantitative Sciences
- Janssen R&D, United States
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.
Olga Sofia Ponce Quiñonez
- Coordinadora General Técnico de Certificaciones, Control Sanitario
- Argencia Nacional de Regulacion, Control Y Vigilancia Sanitaria (ARCSA), Ecuador
Leonardo Sánchez, PharmD
- Agencia de Regulación Sanitaria (ARSA), Honduras
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.
- Agencia Estatal De Medicamentos Y Tecnología En Salud (AGEMED), Bolivia