ISoP Mid-Year Symposium

Dr. Patrice Verpillat is the Head of the Real World Evidence (RWE) Workstream at the European Medicines Agency (EMA). He is a medical doctor, specialist in epidemiology. Before joinging the EMA, he has worked during 20 years in the pharmaceutical industry where he had positions in several international companies, always dealing with real world data (RWD) and non-interventional studies (NIS) in order to bring RWE into research, access and life-cycle product management.

Dr. Verpillat has published over 70 articles in Medline referenced journals. He has been involved in many organisations such as ENCePP, ICH M14 working group, European pharma association (efpia) and ISPE.

Miriam Sturkenboom is professor in Real World Evidence, a pharmacoepidemiologist, and head of the department of Data Science and Biostatistics at the Julius Center of University Medical Center Utrecht in the Netherlands. Before that she was professor in Observational Data Analysis at the department of Medical Informatics at Erasmus MC. She is past president of the International Society for Pharmacoepidemiology. Her research interests focus on knowledge discovery from data collected in routine health care to improve evidence on drug and vaccine safety in particular in vulnerable populations (children, pregnancy and elderly). She is coordinator of the European commission funded ConcePTION project aiming to establish a tested system for the monitoring of benefits and risks of medicines in pregnancy, and is co-founder and president of the Vaccine Monitoring Collaboration for Europe (VAC4EU), she coordinated several EMA funded studies. In terms of quantitative research outputs: she supervised more than 50 PhD students, has more than 400 peer reviewed papers in the area of pharmacovigilance, pharmacoepidemiology and medical informatics and an h-index of 93.

Susana Perez-Gutthann, MD, PhD, MPH, FISPE, FRCP
Global Head of Epidemiology at the independent nonprofit Research Triangle Institute (RTI) Health Solutions division. Susana is past co-chair of the Steering Group of the EMA led European Network of Centers of Pharmacoepidemiology and Pharmacovigilance and past president of the International Society for Pharmacoepidemiology. She has over 30 years of experience driving strategy and research for pharmacovigilance, risk management, development, real world evidence, and regulatory activities applying public health and epidemiologic methods.

Edurne Lázaro has a Degree in Pharmacy, Master in Pharmacoepidemiology and Pharmacovigilance. In 2000 she joined the AEMPS, at the Division of Pharmacoepidemiology and Pharmacovigilance. In 2017 she was in charge of the Risk Identification Unit. In 2021, Edurne joined EMA as subject matter expert at the Data Analysis for 1 year. Since 2023 she is the head of the Division of pharmacoepidemiology and pharmacovigilance and director of BIFAP. Edurne Lázaro has been part of international groups such as the EudraVigilance Expert Working Group, Pharmacovigilance Business Team, and SMART (Signal detection methodology).

Judith Brand, PhD, is an epidemiologist who completed her education at Utrecht University (NL) before undertaking postdoctoral research in Sweden and the UK. Throughout her career, she has worked with various types of observational data and study designs to better understand causes and consequences of cancer, cardiometabolic diseases and pregnancy-related conditions. Transitioning into pharmacovigilance at the Uppsala Monitoring Centre (UMC), her current research focus lies in combining evidence from different data sources and methodologies to strengthen pharmacovigilance signal management.

Francesco Salvo is Full Professor of Pharmacology at the Medicine School of the University of Bordeaux, director of the Bordeaux Regional Pharmacovigilance Centre, and Deputy chief of the Public Health Department of the Bordeaux University Hospital.
It’s been around 20 years he’s working in drug safety, first at the Sicilian centre of Pharmacovigilance in Messina, Italy, then for Italian network of regional PV centres and for the signal detection group of the Italian Medicine Agency (AIFA).

In 2008 he moved to Bordeaux and was involved in pharmacoepidemiology research projects funded by European Commission.

From 2014 to 2020, he assessed safety of clinical trial sponsored by the Bordeaux University Hospital, and he was involved in real-life safety studies conducted by the French platform “Drugs-Safe”, supported by the French Medicine Agency (ANSM).

Since 2017, he is the coordinator of the European Programme of Pharmacovigilance and Pharmacoepidemiology (Eu2P).

Vijay Kara is a Director of Safety Innovation and Analytics group within GSK’s Global Safety organisation. He is an experienced pharmacovigilance expert with over 15 years of experience in the field.
Through his career, Vijay has held several positions in multiple pharmaceutical companies, where he has gained extensive knowledge and expertise in various aspects of pharmacovigilance including signal detection and management, risk management, supporting filings for new products/ indications, licence renewals and safety governance.
He has also co-authored multiple publication in pharmacovigilance helping to shine a light on current challenges.

Eric Smith, PharmD is currently SERM Head, Executive Director at GlaxoSmithKline (GSK) where he is responsible for overseeing benefit risk management of GSK products and manages a team of Patient Safety Physicians and Scientists who provide aggregate level safety surveillance, signal detection and evaluation of GSK investigational and marketed products and produce PV deliverables such as Risk Management Plans, Periodic Reports including PBRERs and DSURs across the Oncology therapy area.
Prior to this current position, he worked over 25 years in the pharmaceutical industry, primarily in Patient Safety with a particular focus on Signal Management, Safety Evaluation & Risk Management for GSK, AstraZeneca, Pfizer, and King Pharmaceuticals.
Eric earned his Bachelor of Science and Doctor of Pharmacy degrees from the University of North Carolina at Chapel Hill.

Linda Härmark, PhD, PharmD, epidemiologist, MBA, studied pharmacy at the University of Uppsala, Sweden before she relocated to the Netherlands and joined the Netherlands Pharmacovigilance Centre Lareb. She has 20 years of experience in the field of pharmacovigilance and currently holds the position of deputy director at Lareb. She is/has been the Lareb lead participant in international projects such as IMI WEB-RADR and IMI Conception project and the EDCTP PAVIA project. Her main research area is patient involvement in pharmacovigilance. She has (co)-authored more than 40 peer-reviewed papers in the field of pharmacovigilance.

Louis Létinier is the co-founder and medical director of Synapse Medicine. He is a doctor specializing in pharmacovigilance and pharmacoepidemiology. Louis remained close to the hospital-university world where he had the opportunity to work in the Pharmacology department of the Bordeaux University Hospital. He also completed a one-year mobility at the University of Tokyo. He is the author of several publications relating to the use of AI in pharmacovigilance.

Professor Sir Munir Pirmohamed (MB ChB, PhD, FRCPE, FRCP, FFPM. FRSB, FBPhS, FMedSci) is David Weatherall Chair in Medicine at the University of Liverpool, NHS Chair of Pharmacogenetics, and a Consultant Physician at the Royal Liverpool University Hospital. He is Director of the Centre for Drug Safety Sciences, and Director of the Wolfson Centre for Personalised Medicine. He is also Director of HDR North. He is an inaugural NIHR Senior Investigator, Fellow of the Academy of Medical Sciences in the UK, Commissioner on Human Medicines. He was President of British Pharmacological Society from January 2020-December 2021, and is currently President of the Association of Physicians. He was awarded a Knights Bachelor in the Queen’s Birthday Honours in 2015. His research focuses on personalised medicine, clinical pharmacology and drug safety in a variety of disease areas, including cardiovascular medicine.

Caridad Pontes, MD PhD. Specialist in Clinical Pharmacology.  
Associate Professor at the Department of Pharmacology, Therapeutics and Toxicology of the Autonomous University of Barcelona.  Consultant at the Clinical Pharmacology Service of Hospital de la Santa Creu i Sant Pau. European Expert appointed by the Spanish Medicines Agency for Scientific Advice procedures.
Previous experience as Senior Management position at the Catalan Health Service for 7.5 years covering HTA functions and Executive Manager of Medicines Area. Consultant Physician at Clinical Pharmacology Unit, Parc Taulí Hospital for 6 years. Previousl, 15 years experience in pharmaceutical industry, mainly in early phase clinical development, pharmacovigilance and pharmacoepidemiology.
Scientific production: 94 indexed publications, H index: 21. Investigator in 6 EU and 4 National competitive projects.  Director of 13 doctoral theses.
President of the Catalan Society of Pharmacology since 2019, member of the Executive Council of the European Association for Clinical Pharmacology from 2013 to 2017, and since September 2023 to present.

Dr Jessica Wright is Head of the Yellow Card Biobank, based in the Safety and Surveillance section of the UK Medicines and Healthcare products Regulatory Agency (MHRA). Prior to this she was a Senior Clinical Project Manager at Clinical Practice Research Datalink (CPRD), a real-world data service supporting recruitment to research studies. She has managed national clinical trials and the Oxford Radcliffe Biobank. Her PhD looked at the challenges for harmonising biobanking in the UK.

Family physician at the Catalan Institute of Health. 1998-2014.
Director of a Primary Health Care Center. Catalan Institute of Health. 2006-2017.
Assistant to the Primary Care Department of the Catalan Institute of Health. 2017-2019.
Head of the Corporate Patient Quality and Safety Area of the Catalan Institute of Health. 2014-2019.
Deputy Director General of Health and Pharmaceutical Management and Quality. Directorate General of Health Planning and Regulation. Health Department. Government of Catalonia. November 2019-2022.
CEO of the General Directorate of Health Organization and Regulation. Health Department. Government of Catalonia. November 2022-currently.

Graduated in Pharmacy from the University of Granada, PhD from the University of Murcia in biochemistry and since 2004 I have worked in the Pharmacovigilance Center of the Region of Murcia, adapting to the challenges that pharmacovigilance has evolved in recent years such as notification of the patient, electronic notification, the use of databases as a research tool, member of the monitoring committee and the BIFAP advisory committee since 2012. I have also participated in several working groups at the local level as coordinator of several groups of work of the Regional Commission of Pharmacy and Therapeutics, as well as other groups at the national level of the Technical Committee on Pharmacovigilance of the AEMPS.

Dr Ryan Walker is a pharmacist, project manager and methodology researcher at The Global Health Network, University of Oxford, a global organisation that supports researchers to do research in settings where research doesn’t happen. Having trained as a pharmacist at the University of Nottingham and University Hospitals of North midlands NHS Trust (UK), he undertook his PhD investigating how a community of practice-led methodology could strengthen pharmacovigilance capacity in low-resource settings at the University of Oxford (UK). As a project and research manager, he currently co-ordinates The Global Health Network’s pharmacovigilance and antimicrobial resistance-focused initiatives. In addition to his profession role, Dr Walker is a founder and the current secretary of the UK and Ireland ISoP Chapter, and is a member of the Global Antimicrobial Stewardship Partnership Hub Advisory Board.

Dr. Irina Caplanusi is currently Signal Management Lead in the Pharmacovigilance Department at the European Medicines Agency. She has over fifteen years of experience working in signal management (including leading on Signal Procedures at the Pharmacovigilance Risk Assessment Committee), incident management (including Emerging Safety Issues and the EU Incident Management Plan), safety communication and international regulators collaboration. In the recent years she worked extensively in the pharmacovigilance of COVID-19 vaccines, from safety monitoring to leading on high profile signal procedures.

Dr Clara Suñer is a post-doctoral research scientist at the STI and Skin NTD Unit of the Fight Infections Foundation – Hospital Universitari Germans Trias i Pujol (Barcelona, Spain). Dr Suñer holds a BA in Pharmacy from the University of Barcelona, an MSc in Biomedical Research from the Pompeu Fabra University and a PhD in molecular biology from the Institute for Research in Biomedicine (IRB Barcelona). Transitioning from fundamental to clinical research in 2020, Dr Suñer has conducted observational studies and clinical trials in several infectious diseases, including COVID-19, Mpox, and Yaws. Her research interests are mainly infectious disease transmission, diagnosis, and public health strategies, with a current focus on Mpox vaccine effectiveness and innovative tools for Tuberculosis diagnosis.

Antònia Agusti is a professor of Pharmacology and clinical Pharmacology of the Department of Pharmacology, Therapeutics and Toxicology at Universitat Autònoma de Barcelona and Head of the Clinical Pharmacology Service at Vall d’Hebron University Hospital in Barcelona. She was trained as a medical doctor specialised in clinical pharmacology at Vall d’Hebron University Hospital. Her main area of research has been meta-analyses in some cardiovascular areas such as treatments for heart failure and also, drug utilisation studies focused on the translation of results of clinical trials into clinical practice. She is the current president of the Spanish Society of Clinical Pharmacology and has been participating for more than ten years in the European Master in Pharmacovigilance and Pharmacoepidemiology (Eu2p) being the director of one of the master domains. She is co-(author) of around 120 published papers in peer reviewed medicine magazines.

Dr. Agnes Kant is epidemiologist and since 2013 director of the Netherlands Pharmacovigilance Centre Lareb. Lareb is the reporting and knowledge centre for adverse drug reactions (ADRs) and drug use during pregnancy and lactation in the Netherlands. The centre has experience in promoting reporting ADRs for both health care professionals as well as patients, causality assessment and signal detection, cohort event monitoring, innovation of Pharmacovigilance and communication. Lareb is an independent foundation, funded by the drug regulatory authority (MEB), and the Ministry of Health.

Marco Tuccori was born in Lucca (Italy) in 1976. In 2001, he graduated with Honors at the School of Pharmacy of the University of Pisa. From 2002 to 2005, he attended the Post Graduate School of Pharmacology at the University of Pisa. He achieved the PhD in Pharmacology and Medical Physiology at the University of Pisa in 2010 with a project of research on the risk of progressive multifocal leukoencephalopathy in non-Hodgkin lymphoma patients receiving rituximab. In August 2009 he started to work as Pharmacist Head at the Unit of Clinical Pharmacology at the University Hospital of Pisa. Since March 2012 he has been employed as Pharmacovigilance Manager at the Unit of Adverse Drug Reactions Monitoring of the University Hospital of Pisa. He is currently one of the coordinators of the Tuscan Regional Centre of Pharmacovigilance and collaborates with the Agenzia Italiana del Farmaco (AIFA) as member of the Working Group for Signal Detection Analysis on Drugs and Vaccines. He is free-of-charge professor of Pharmacovigilance and Evidence Based Medicine at the department of Pharmacy of the University of Pisa. He is currently in charge of several courses of Pharmacology, Pharmacovigilance and Pharmacoepidemiology at the post-graduate school (specialization) of Pharmacology, Gastroeneterology, Otolaryngology and Traumatology at the University of Pisa. He was a member of the advisory board of the International society of Pharmacovigilance (ISoP) from 2012 to 2019. In 2015 he attended a post-doc fellowship at the Centre for Clinical Epidemiology, Lady Davis Institute, Jewish General Hospital, McGill University (Montreal, Canada). Since 2022 he is co-chair of the Scientific Board of the ISoP. He is the author of about 100 articles in peer reviewed scientific journals and 4 chapters on books.

Marco Tuccori is coordinator of the Pharmacovigilance Regional Centre of Tuscany (Italy). He is currently co-chair of the Scientific Board of ISoP and Coordinator of the ISoP European Chapter.

Gianluca Trifirò is MD, with post-graduate degree in Clinical Pharmacology and PhD in Pharmacoepidemiology. He currently works as Full Professor of Pharmacology at the University of Verona.
He is scientific coordinator of the Postgraduation Degree in Clinical Pharmacology and Toxicology and of a Master program on “Use of Real-world data for evaluations in Pharmacovigilance, Pharmacoepidemiology and Pharmacoeconomics” at University of Verona. He is the scientific coordinator of the Italian Society of Pharmacology working group on pharmacoepidemiology and pharmacovigilance.
Since around 20 years he has been fully involved in ISOP, where he currently acts as Chair of the Big Data and RWE Special Interest Group. He is Fellow of both International Society of Pharmacovigilance and International Society of Pharmacoepidemiology. He is member of the steering group of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) of European Medicine Agency. He is Editor in Chief of the journal Frontiers in Drug Safety and Regulation. Authors of more than 250 publications PV- and clinical pharmacology-related on international scientific peer-reviewed journal.

Felipe Villalobos is a medical doctor graduated from the Universidad Autonoma Metropolitana in Mexico. He has a Master’s degree and a PhD from the Universitat Rovira I Virgili in Spain. He is currently a researcher in primary care at the IDIAP Jordi Gol primary care research institute in Barcelona, Spain, with a line of research in health promotion and preventive activities. He is a lecturer in the Faculty of Health Sciences at the Universitat Oberta de Catalunya, member of the European Health Parliament in the well-being for healthcare professionals committee, and coordinator of the ISoP European Chapter.

Martín Solórzano is a Mexican Medical Doctor. He has led many teams and health programs in his country and Spain, especially projects focused on vulnerable population. In 2013, he was selected as Mexican Youth Delegate to the UN in New York City. Since then, he has been collaborating with several international Governmental and Gon-Governmental Institutions in the making of decisions on Public Health, and Social Development. Martín Solórzano holds a master’s degree on Public Health and Health Management by the University of Valencia in Spain, and he is a Ph.D. candidate on Epidemiology. Currently, he is a project manager for the IDIAPJordi Gol in Barcelona leading projects on Health Evaluation and Research.

Marco Tuccori was born in Lucca (Italy) in 1976. In 2001, he graduated with Honors at the School of Pharmacy of the University of Pisa. From 2002 to 2005, he attended the Post Graduate School of Pharmacology at the University of Pisa. He achieved the PhD in Pharmacology and Medical Physiology at the University of Pisa in 2010 with a project of research on the risk of progressive multifocal leukoencephalopathy in non-Hodgkin lymphoma patients receiving rituximab. In August 2009 he started to work as Pharmacist Head at the Unit of Clinical Pharmacology at the University Hospital of Pisa. Since March 2012 he has been employed as Pharmacovigilance Manager at the Unit of Adverse Drug Reactions Monitoring of the University Hospital of Pisa. He is currently one of the coordinators of the Tuscan Regional Centre of Pharmacovigilance and collaborates with the Agenzia Italiana del Farmaco (AIFA) as member of the Working Group for Signal Detection Analysis on Drugs and Vaccines. He is free-of-charge professor of Pharmacovigilance and Evidence Based Medicine at the department of Pharmacy of the University of Pisa. He is currently in charge of several courses of Pharmacology, Pharmacovigilance and Pharmacoepidemiology at the post-graduate school (specialization) of Pharmacology, Gastroeneterology, Otolaryngology and Traumatology at the University of Pisa. He was a member of the advisory board of the International society of Pharmacovigilance (ISoP) from 2012 to 2019. In 2015 he attended a post-doc fellowship at the Centre for Clinical Epidemiology, Lady Davis Institute, Jewish General Hospital, McGill University (Montreal, Canada). Since 2022 he is co-chair of the Scientific Board of the ISoP. He is the author of about 100 articles in peer reviewed scientific journals and 4 chapters on books.

Marco Tuccori is coordinator of the Pharmacovigilance Regional Centre of Tuscany (Italy). He is currently co-chair of the Scientific Board of ISoP and Coordinator of the ISoP European Chapter.

Linda Härmark, PhD, PharmD, epidemiologist, MBA, studied pharmacy at the University of Uppsala, Sweden before she relocated to the Netherlands and joined the Netherlands Pharmacovigilance Centre Lareb. She has 20 years of experience in the field of pharmacovigilance and currently holds the position of deputy director at Lareb. She is/has been the Lareb lead participant in international projects such as IMI WEB-RADR and IMI Conception project and the EDCTP PAVIA project. Her main research area is patient involvement in pharmacovigilance. She has (co)-authored more than 40 peer-reviewed papers in the field of pharmacovigilance.

Ghita is a pharmacist who started her career in a private pharmacy in Rabat, Morocco for 5 years before joining the Moroccan Poison and Pharmacovigilance Centre, in 2001. She has taken part in several pharmacovigilance training, research and development projects, in collaboration with the World Health Organization, the World Alliance for Patient Safety, the UMC and the Moroccan Pharmacovigilance Center, to promote pharmacovigilance, vaccine pharmacovigilance and develop new analysis tools for French-speaking African and Eastern Mediterranean countries. She participated in the drafting of a WHO guide on the role of pharmacovigilance centers in the detection of medication errors. Since 2017, she has been teaching clinical pharmacology at the Faculty of Dentistry at Rabat International University. Ghita is a member of the ISoP advisory board, the SIG ISoP medication errors and international networks for patient safety, medication errors and vaccines.

Gianmarco Di Mauro serves as the Head of Partnerships at Teamit, overseeing the unit dedicated to the scientific management of pharmacoepidemiology, safety, and efficacy studies related to medications, medical devices, and vaccines using real-world evidence. Additionally, he holds the position of Projects and Business Development Manager at VAC4EU, where he is responsible for identifying and implementing new research opportunities in the field of vaccines’ safety and effectiveness. With a background in molecular biology and a Ph.D. in biomedicine from the Universitat Pompeu Fabra in Barcelona, Gianmarco brings extensive expertise from various research areas, including molecular medicine, neuropharmacology, and epigenetics.

Global leader in medication safety, currently president of the International Society of Pharmacovigilance (ISoP), an institution with presence in 100 countries, whose mission is to improve the medication safety worldly. Pharmacist, Epidemiologist, Ms Pharmaceutical Care, MSc Education. With more than 20 years of experience, she is an international consultant and lecturer in pharmacovigilance, safe use of medications and medical devices, patient safety, patient education, leadership and communication. Member of Research Ethics Committees, she was president of the Colombian Pharmacovigilance Association for 5 years, founding member and Co-chair of the ISoP Special Interest Group (SIG) “Medication errors”. ISoP SIG Risk Communication and SIG Patient Engagement member. Founding member of Latin American Network of Human Factors and Ergonomics in Healthcare Systems (RELAESA). Currently Pharmacy Career Director in Pontificia Universidad Javeriana.