Natalia Hristov, PharmD, is a pharmacovigilance professional with over 15 years of experience working with drug safety in pharma companies overseeing Latin America countries. Most recently, Natalia was nominated as ad interim Pharmacovigilance Head of Americas at Merck and added Canada and US to her scope. One of her drivers has been the implementation of breakthrough technologies to the efficient and valuable exchange and use of drug safety data.

Deirdre McCarthy is a Senior Director, Pharmacovigilance and Safety Operations at AlloVir, an ElevateBio company, and is based in Boston, USA. She previously held leadership roles in Quintiles/IQVIA in EU, US and Argentina. She is also a member of the Executive Committee of the International Society of Pharmacovigilance. She holds a Degree in Biochemistry from Trinity College Dublin and a Masters in Pharmacovigilance from University of Hertfordshire, UK. Prior to joining IQVIA, Deirdre held positions in pharmacovigilance in the Irish Medicines Board as well as in industry.

Michelle Souza is graduated in Pharmacy - Biochemistry with MBA degree in Strategic Innovation Management and has been working with Pharmacovigilance in the Pharma Industry since 2011. Currently she has a position as n-QPPV at AbbVie Pharmaceuticals in Brazil.

Patient Safety Manager at PGA Farma responsible for supporting activities related to patient safety, in clinical trials and post marketing activities, for different pharmaceutical companies with the objective to help them reach their internal process with high performance and quality according to requirements from differenece healthy authorities. Professional with over 20 years of experience in pharmacovigilance in national and international pharmaceutical industry, working on different kind of operations like Pharmacovigilance, Technovigilance, Cosmetovigilance and Nutrivigilance owith process related to clinical development and postmarketing.

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.

Raphael has more than 16 years of experience in Pharmacovigilance, beginning at Sanofi Brazil, where he acted in roles of increasing responsibility within local PV organization, responsibilities including oversight of case management, PSUR management and RMP management. Raphael also worked for Johnson & Johnson as associate manager, with responsibility for 18 countries within Latin America in processes like PSURs, PV Agreements, oversight of reporting to Health Authority and of contracts with vendors and business partners. Also worked at MSD Brazil as Associate Director with experience in PV and Quality & Compliance for PV and Regulatory for Americas. Since Aug.2022 Raphael is Head of PV Brazil at Roche.

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.

Guilherme Julian is Pharmacist with Master Degree in Psychobiology and currently leads Real World Insights for Latin America in IQVIA. He has over than 10 years of experience in research, of which more than 6 in Real World and RCT studies. Counting with more than 50 publications in scientific journals and international conferences, mainly focused in RWE.

Robin M. Weinick, PhD. brings 25 years of experience to her DIA role as Senior Vice President & Managing Director, Americas, and Global Program Officer.Robin joins DIA from RTI International, a large, nonprofit research institute dedicated to improving the human condition. She also has served as Associate Director for Health at the RAND Corporation, a premier U.S.-based think tank, and on the faculty of Harvard Medical School and Massachusetts General Hospital. She began her career in federal service with the U.S. Department of Health and Human Services. She holds a B.A. in Health and Society from the University of Rochester and a Ph.D. on Population Dynamics from Johns Hopkins University.

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.

Pharmacist with over ten years of experience in pharmacovigilance and cosmetovigilance regulations. Qualified person responsible for pharmacovigilance (QPPV) at Ache Laboratorios Farmaceuticos S.A in Brazil. Team management in general. Currently participating in WHO pilot project to improve pharmacovigilance regulations in Brazil. Participation in pharmacovigilance associations in Brazil.

She is pharmaceutical-biochemical graduate from the Faculty of Pharmaceutical Sciences of Araraquara. She has a specialization in Sanitary Surveillance from the School of Public Health at USP and in Sanitary Surveillance in Public Health from FIOCRUZ. In 2005, he completed a Master's in Pharmaceutical Sciences in the area of ??technological development and quality control of pharmaceutical products by the Federal University of Rio Grande do Sul. He is part of the professional staff of the National Health Surveillance Agency (ANVISA) since March 2000 in the field of medicines, where he worked for two and a half years as a Generic Medicines Manager. Currently works in the Pharmacovigilance area of ??ANVISA since 2008.

Dr. Straus’ team oversees global clinical safety for investigational products as well as post-licensure safety monitoring and assessment for the Merck portfolio in vaccines and infectious disease therapeutics. He is trained as an internist, gastroenterologist, and epidemiologist. He is actively involved in human research subject protection, and a member of US Health & Human Services Secretary's Advisory Committee on Human Research Proion (SACHRP), as well as in professional groups working in infectious disease and pharmacoepidemiology.

Pharmacist graduated from Universidade de São Paulo (USP) with 10 years of experience in Pharmacovigilance and Drug Safety in multinational Pharmaceutical Industry. Extensive experience in product safety surveillance, risk management and benefit/risk related activities. Implementation of innovative projects in risk communication.

I am a Physician who qualified and practiced intensive care medicine in the UK, before joining the Pharmaceutical industry. I occupied several positions in Clinical Research, including Country Medical Department and Clinical Research Operations management based in the UK, Belgium and the USA. I entered PV full time as the EUQPPV based in Belgium where I was involved with EFPIA during the implementation Phases of the EU PV modules and co-authored several papers: and subsequently moved back to the USA to lead a Clinical Safety Franchise, I am Currently Head of Global Pharmacovigilance. I was delighted to participate in the Transcelerate Value of Safety Information which has provided valuable data around the relative utility of ICSR sources.

Calvin has an MSc in Pharmacovigilance and has worked in PV for over 18 years. He started his career in large pharma in clinical safety and has held a variety of clinical and post-marketing roles in small and large pharma that included medical information and Deputy EEA QPPV responsibilities. He spent five years at the MHRA as a Senior PV inspector. He joined AbbVie in 2013 and is currently responsible for leading the International PV Operational Excellence team who oversee the performance of Affiliate pharmacovigilance functions across the globe and drive local safety excellence.

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.

Ms Agostini has Bachelor degree in Pharmacy by São Judas University and Post-Graduation in Pharmaceutical Medicine by UNIFESP, and Pharmacovigilance by ICTQ. Ms. Agostini has over more than 10 years of experience in Pharmaceutical Industries working specifically with Pharmacovigilance – dedicated to product safety monitoring about medicinal product, cosmetic and medical device. Also, was developed during this years a big knowledge regarding customer relationship and medical information which are a plus in her pharmaceutical career. Deep knowledge in the development and local implementation of the Risk Management Plan. Responsible for implementing innovative local digital actions regarding Risk Management Plan.

Melissa Truffa is the Director of Policy and Strategy Evaluation, Pharmacovigilance Excellence with Abbvie. She has extensive experience with safety surveillance and signal management for investigational and marketed products. Melissa’s prior experience includes 15 years of US FDA experience with various positions in the Office of Surveillance and Epidemiology, Division of Pharmacovigilance and the Office of New Drugs, Division of Antiviral Products. Melissa earned her BS in Pharmacy from the University of Pittsburgh, School of Pharmacy, and a certificate of pharmacoepidemiology from the University of Pennsylvania/FDA educational program and a certificate of Public Health from the Georgetown University/FDA educational program.