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.

I am a pharmaceutical-biochemistry with post-graduation in "Audits, Sanitary vigilance and quality Assurance", working with Pharmacovigilance since Feb-2011. Currently, I'm PV manager and National QPPV at AbbVie Brazil and I'm coursing a MBA in Pharmaceutical Industry.

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.

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.

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.

Louise Molloy acquired her Pharmacy degree at Trinity College Dublin in 2008 and has recently completed a master’s in Industrial Pharmaceutical Science with the Royal College of Surgeons Dublin. After graduation she spent some years in Clinical pharmacy, working with the hospital drugs & therapeutics’ committee to develop SOPs for rational use of medicine in the hospital setting. Since relocation to Argentina she managed Quality and training development for a team of over 60 in a large Contract Research Organization.

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.

Cardiologist and Clinical Trialist. Director of the Academic Research Organization (ARO) of the Hospital Israelita Albert Einstein

Sonam Desai is an International Business Manager within the Global Pharmacovigilance and Epidemiology department at Bristol Myers Squibb. She has 5 years of experience in the field of pharmacovigilance and is involved in safety database upgrades/releases to ensure alignment between business processes, regulations and system capabilities. Prior to her current role Sonam held the position of Senior Safety Scientist and has leveraged her background to lead and support projects aimed at streamlining and automating the repetitive tasks associated with individual case safety report (ICSR) processing.

Graduated in Medicine in 1992 and completed medical residence in gastroenterology in 1996 both at Rio de Janeiro State University-UERJ in Brazil. Worked at GSK Brazil from 2003 to 2008 as Medical Affairs & Safety Manager. In 2008 joined Genzyme Latin America as Regional PV Director. In 2012 started in Sanofi as International PV Coordinator for Latin America becoming Latin America Regional Safety Lead from 2006 to 2008, when named Regions Medical Safety Head, overseeing the safety governance for Sanofi local products worldwide. Completed PV post-graduation in 2012 and PV Masters Degree in 2014 both at the DSRU/University of Portsmouth, UK. Certified in PV & Clinical Safety by DIA, member of ISoP and ISPE.

Head of Pharmacovigilance ANMAT. Physician, graduate from Medical Faculty of the University of Buenos Aires (UBA). Specialist in Pediatric medicine Dermatology, with the Ministry of Health Argentina & UBA. Noted publications: Author of Latin America edition of ¨Manual Good pharmacovigilance practices". Participation in Argentinian edition of manual of GVP. Director of pharmacovigilance course ANMAT. Has led multiple pharmacovigilance meetings and symposia with ANMAT.

Maria Lúcia atended the School of Medicine (2003-2008) and completed her training in Internal Medicine at the University of São Paulo (2009-2011). At the Federal University of São Paulo, she completed her training in Nephrology (2012-2014) and has worked with Chronic Kidney Disease patient care focusing in the clinical management of the advanced disease and its consequences as well as in the process of chosing an adequate renal replacement therapy. Maria Lúcia has also experience in the care of patients who have undergone kidney transplantation and their peculiarities. Since 2018, her role is as a safety physician at Eli Lilly.

Phil is the Deputy Director of Patient Safety Monitoring within MHRA’s Safety & Surveillance function and has over twenty years of experience working in pharmacovigilance. Prior to his current role Phil spent fourteen years leading and developing the pharmacovigilance system, including technology, processes, and relevant aspects of Pharmacovigilance Legislation. He is now accountable for Patient Safety Monitoring across medicines, vaccines, devices, defects and blood products. Phil was responsible delivery of MHRA systems for COVID-19 vaccine surveillance and their integration into the healthcare system. For several years he has led international projects to develop and deliver tools for global pharmacovigilance.

Farmacêutica especialista em Vigilância Sanitária e Saúde Coletiva e mestre em Farmácia com ênfase em Saúde Pública e Análises Clínicas pela Universidade Federal de Santa Catarina. Mais de 10 anos de experiência em planejamento, gestão e execução orçamentária, com sólida carreira envolvendo logística de insumos estratégicos para saúde. Desde 2011 é responsável pelas gestão de 77 insumos para prevenção, diagnóstico, monitoramento e tratamento de HIV e outras Infecções Sexualmente Transmissíveis em âmbito nacional, e diretamente pela manutenção contínua do tratamento antirretroviral de mais de 600 mil pessoas no Brasil. Adicionando às responsabilidades a intensa atividade voltada à negociação de contratos na ordem de R$ 1,4 bilhão.

Bachelor - Biological Sciences, MSc - Immunology and Pharmacology, PhD - Psychiatry, Genomics, Big Data (in progress)

Christian brings more than 20 years of operational and commercial experience across multiple sectors to his role at Medidata, the market leader for SaaS, analytics and data science solutions for the life science industry. As managing director of EMEA (Europe, the Middle East and Africa), he plays an integral role in the development and execution of the Company’s overall growth strategy and success within the EMEA market. Christian joined Medidata from Salesforce.com, where he was the regional vice president for Central Europe. Prior to that, Christian spent seven years at Oracle Corporation.

Helaine Capucho is graduated in Pharmaceutical Sciences, PhD in Science, and specialist in Hospital and Clinical Pharmacy. She was responsible for implementing Patient Safety and pharmacovigilance programs in 40 brazilian federal teaching hospitals. Her publications are focused on hospital pharmacy, pharmacovigilance and patient safety. She is currently an assistant professor at University of Brasilia (UnB) for the Department of Pharmacy of the Health Sciences College, in Brazil, where her teaching and research on pharmacovigilance take place. Moreover, she is a member of the special interest group on medication errors of the ISoP.

Pedro is a PharmD/MBA who works as the Safety Officer for Brazil (supporting Regional PV Lead for LATAM) at Allergan. Pedro has more than 16 years’ industry and CRO experience in several Pharmacovigilance roles at Aventis Pasteur, Wyeth, MSD, Roche, Sanofi, Syneos Health and Allergan. His areas of expertise are the Brazil and LATAM PV systems, strengthening of PV systems in the region and teach about PV in postgraduate programs and scientist events. In his belief that everyone has a role to play in ensuring patient safety, he has been working for the harmonisation of the PV regulations as a member of PV groups in external association (Sindusfarma/ Brazil) as well as advocating for public PV education and effective safety communications.

As a nurse I worked in an intensive care unit (ICU) for 5 years. Then I joined CRO as drug safety for another 5 years followed by pharmaceutical industry experience for 9 years. I completed a postgraduate degree in intensive care and an MBA in project management from FGV in 2017.