ISoP Mid-Year Symposium
In pharmacovigilance, various scientific disciplines such as epidemiology, (clinical) pharmacology, and medical science are necessary to monitor the safe use of drugs.
where science meets clinical practice
In collaboration with Lareb
1-2 June 2023
National Museum Boerhaave, Leiden Netherlands
This event has now passed.
Handouts are available for attendees here
The faculty for this course consists of international and national experts in pharmacovigilance, clinical pharmacology and pharmacoepidemiology, representing government, academia, and industry.
Chairpersons and Speakers
Rebecca is a physician, educated and trained in internal medicine and infectious diseases in the USA. She discovered pharmacovigilance when she accepted a job at the Swedish Medical Products Agency in 2008 as a clinical safety assessor, reviewing both pre- and post-marketing safety data for a number of different types of medicinal products, including vaccines. Her passion for vaccine safety emerged with the narcolepsy/Pandemrix signal during the H1N1 influenza pandemic.
She subsequently moved to the Uppsala Monitoring Centre where she was engaged in the development of new methods using spontaneous reports and building pharmacovigilance capacity throughout the world. As the vaccine expert for the UMC, she participated in many global vaccine safety groups, such as the CIOMS Working Group for Vaccine Safety and meetings of the Global Vaccine Safety Initiative.
She currently works for the Coalition for Epidemic Preparedness Innovations (CEPI) as Clinical Development Vaccine Safety Lead. In that role she is project leader for the partnership between CEPI and the Brighton Collaboration of the Task Force for Global Health, SPEAC or Safety Platform for Emergency vaccines. She is eager to increase awareness and uptake of Brighton AESI definitions and tools within pharmacovigilance.
Toine Egberts (1965) obtained his PharmD in 1990 at the University of Groningen, the Netherlands. Thereafter he was trained as a clinical pharmacist during four years in the hospitals of Tilburg and Delft. In 1994, he started his PhD project at the department of Pharmacoepidemiology & Clinical Pharmacology of Utrecht University in collaboration with the Netherlands Pharmacovigilance Foundation ‘Lareb’. This resulted in 1997 in a thesis entitled ‘Pharmacoepidemiologic approaches to the evaluation of antidepressant drugs’. During his PhD-project he obtained the Master of Science degree in clinical epidemiology at the Netherlands Institute of Health Sciences.
He was appointed in 2001 as professor of clinical pharmacoepidemiology at the department of Pharmacoepidemiology & Clinical Pharmacology. Since 2006 he is also a professor of clinical pharmacy at the medical faculty of Utrecht University. In these positions he tries to bridge the drug environment and the patient environment.
From 2006 – 2017 he was the chief pharmacist of the department of clinical pharmacy of the University Medical Center Utrecht. In addition, he was during 5 years member of the board of directors of the division of laboratories and pharmacy of the University Medical Center Utrecht.
Since november 2018 he is director of doctor education of the Graduate School of Life Sciences of the Utrecht University. The coaching of PhD students gives him energy as it nicely balances performing research into medical/pharmaceutical puzzles with the personal development of young academic professionals. He had the opportunity to guide over 65 PhD students towards the ‘hora est’. He has always been deeply involved in education, especially the training of hospital pharmacists, for which he received in 2016 the ‘Senior Jan Glerum Award’.
He is (co)author of around 500 international peer reviewed scientific publications and acts as a reviewer for several scientific journals and international research funding organisations. For his research related to clinical pharmacy he received the ‘Huizinga penning’.
He is a member of the editorial board of the journal Drug Safety. He is member of several committees such as the CCMO, the Netherlands Expertcenter for Pharmacotherapy for older people (EPHOR), and the advisory board of the Dutch Association of Hospital Pharmacists.
His research activities focus on a) the clinical pharmacology / clinical pharmacoepidemiology of drugs used in daily clinical practice, and b) on innovations in clinical pharmacy systems. In addition, he tries to promote sustainability in pharmacy (‘green pharmacy’).
Jean-Luc Faillie is a French physician specialized in public health and clinical pharmacology. He completed a university thesis in pharmaco-epidemiology at the University of Toulouse in 2014. He is a professor of medical pharmacology at the Faculty of Medicine of Montpellier, and, since 2018, he coordinates the Department of Medical Pharmacology and Toxicology at the University Hospital of Montpellier. He is the head of the Regional Pharmacovigilance Center of the Occitanie-Est region. His research interests include pharmacovigilance and pharmaco-epidemiology, particularly in the area of diabetes drugs.
Dr Helga Gardarsdottir is an associate professor at the Division of Pharmacoepidemiology & Clinical Pharmacology (Utrecht University, NL) and one of the principal investigators at the Division. Her primary research interests include the application and development of innovative approaches to generate and analyse real world data on safety and effectiveness of medicines to inform regulatory and clinical decision making. Special research interest includes assessing impact of drug regulation on safe and effective use of medicines in populations. Dr Gardarsdottir was trained as a pharmacist at Uppsala University in Sweden and worked for two years at the International Pharmaceutical Federation (FIP) in The Hague following her graduation.
She obtained her PhD in pharmacoepidemiology from Utrecht University in 2009 and worked until 2017 as a researcher at the department of Clinical Pharmacy at the University Medical Center Utrecht. She has led and participated in several international multi-country research projects including the IMI-PROTECT project and the IMI Trials@home project. She is an elected member of the ENCePP (European Network of Centres for Pharmacoepidemiology and Pharmacovigilance) steering group, co-led the Real-World Evidence Task Force of the International Society of Pharmacoepidemiology (2019-2022) and is an associate editor of the journal ‘Pharmacoepidemiology & Drug Safety’. She is a (co-)author of over 90 scientific publications in peer reviewed journals.
Tobias Gerhard is the Founding Director of the Rutgers Center for Pharmacoepidemiology and Treatment Science and currently serves as Interim Director of the Rutgers Institute for Health, Health Care Policy and Aging Research. He received his pharmacy degree from the University of Freiburg, Germany (2002), and his PhD in pharmacoepidemiology from the University of Florida (2007). Dr. Gerhard’s work focuses on the development and evaluation of modern pharmacoepidemiologic methods with applications in mental health and geriatric pharmacotherapy. He has extensive experience working with large claims and electronic health record datasets and has published widely on use, safety, and outcomes of therapeutics, particularly of psychotropic medications in vulnerable populations.
His work has been funded by NIA, NIMH, AHRQ, PCORI, and by multiple foundations. Currently, he serves as Principal Investigator of two R01 awards from the National Institute on Aging (NIA). His work has been recognized with a Young Investigator Award from the Brain and Behavior Research Foundation, a New Investigator Award from the American Society of Clinical Psychopharmacology, and the 2020 Sternfels Prize for Drug Safety Discoveries. Dr. Gerhard is a Fellow of the International Society for Pharmacoepidemiology (ISPE) and its current President, and an elected member of the American Epidemiological Society.
He has served on committees for FDA and the National Academies of Sciences, Engineering, and Medicine (NASEM).
Henk-Jan Guchelaar PharmD PhD studied Pharmacy at the Rijksuniversiteit Groningen (RuG) and specialized as a hospital pharmacist and clinical pharmacologist. Since 2003, he is employed as a clinical pharmacist and clinical pharmacologist and professor of clinical pharmacy and chair of the department of Clinical Pharmacy & Toxicology at Leiden University Medical Center.
Since October 2008, he is also appointed professor of Clinical Pharmacy at the Faculty of Science, Leiden Academic Center for Drug Research, University Leiden and chair of the Leiden University focus area ‘Translational Drug Discovery and Development’.
Pharmaceutical patientcare in oncology is his main area of clinical interest. He is program leader of the research program ‘Personalised Therapeutics’ investigating interindividual variability of drug response with an emphasis on pharmacogenomics. He is (co-)author of more than 600 (Web of Science indexed) articles (Pubmed: 420) in international peer reviewed scientific journals.
Guchelaar is coordinator of the EU funded Horizon 2020 project Ubiquitous Pharmacogenomics (www.upgx.eu) aimed at implementing pre-emptive pharmacogenomic testing in the EU.
From 2010-2016 he was a member of the national Central Committee on Research Involving Human Subjects, from 2003-2017, he was vice-chair of the Dutch Society for Clinical Pharmacology and Biopharmacy, and since 2016 he is member of the Dutch Medicines Evaluation Board. Since 2017, he is member of Council for Medical Sciences of the Royal Dutch Academy of Science and since 2020 member of the Academia Europea. Henk-Jan is founder of the new Master of Pharmacy, Leiden University Medical Center, University of Leiden.
Linda Härmark, PhD, PharmD, epidemiologist, MBA, has more than 15 years experience in the field of pharmacovigilance and currently holds the position of deputy director of the Netherlands Pharmacovigilance Centre Lareb. She is/has been the Lareb lead participant in international projects such as IMI WEB-RADR and Conception project and the EDCTP PAVIA project. Her main research area is patient involvement in pharmacovigilance and the use of web-based intensive monitoring to gather information about ADRs. She has published more than 40 peer-reviewed papers in the field of pharmacovigilance.
Sara is a data scientist with a MSc degree from Uppsala University. She has worked with pharmacovigilance data for the past eight years at Uppsala Monitoring Centre. She has been involved in international projects such as IMI WEB-RADR and the ongoing IMI EHDEN, where she contributes to the Evidence Workflow Development work package and the work on RWD utilisation in PV.
Kaisa Immonen joined the Stakeholders and Public engagement team of the European Medicines Agency (EMA) in 2023. She supports the Agency’s interactions with patients, consumers and healthcare professionals and their organisations.
She has extensive experience of EU health policy and patient involvement. From 2010 until 2023 she was Director of Policy at the European Patients’ Forum and in that capacity co-chaired the EMA Patients and Consumers Working Party in 2016-2022. She also contributed to the OECD’s work on quality and safety of healthcare, the OECD PaRIS patient surveys, work of the WHO European regional office on people-centred health systems, as well as numerous European-level projects, working groups and networks on health policy.
Kaisa holds a Master’s in Health Policy, Management and Innovation from Maastricht University and a Master’s in International Relations from the University of Canterbury.
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.
Dr. Agnes Kant studied Health Sciences at the Radboud University in Nijmegen. She graduated as an epidemiologist in 1989. At the Radboud University she worked as a scientific researcher for 5 years.
In 1997 she became a PhD on a thesis about the organization of screening on cervical cancer. From 1998 until 2010 she was a Member of Parliament of the Socialist Party. In the period 1998-2008 mainly as spokeswoman on Health care. From 2008 until 2010 she was the leader of the Socialist Party.
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.
His most recent co-authored publication entitled “Individual Case Safety Report Replication: An Analysis of Case Reporting Transmission Networks” published in Jan 2023, is the first-ever quantification of replication, helping to shine a light on current challenges in pharmacovigilance.
Maarten Keulemans (Rotterdam, 1968) is science editor for De Volkskrant, leading newspaper in the Netherlands. Before, het worked, among others, for New Scientist (Dutch version), Scientific American and the public broadcasting companies NOS and VPRO.
In 2022, he was awarded the title ‘Journalist of the Year’ by the Dutch Journalist’s Association (NVJ) for his coverage of the Covid crisis. His article series ‘Keulemans in Quarantine’ was shortlisted for several awards and prizes, among other two ‘Tegel’ awards.
Keulemans lives in Leiden with his family.
Department of Clinical and Medical Pharmacology and Regional Pharmacovigilance Centre Faculty of Medicine and Toulouse University Hospital, France
François Montastruc is a medical doctor and clinical pharmacologist who has been working at the Toulouse Regional Pharmacovigilance Centre since 2014. He got his medical degree in Public Health with complementary specialization in Clinical Pharmacology. In 2017, he obtained a PhD degree in Pharmacovigilance/pharmacoepidemiology at the University of Bordeaux, France. During one year (2018), he did a post-doctoral fellowship in the department of Clinical Epidemiology (pharmacoepidemiology), at McGill University, Montreal, Canada. Since September 2021, he is an Associate Professor at the department of Clinical and Medical Pharmacology of the Toulouse University.
Its medical activity is organized around pharmacovigilance and clinical pharmacology. In 2015, he created a medical consultation dedicated to drug-induced diseases and pharmacovigilance. He also does clinical psychopharmacology consultations with the psychiatrists of his hospital.
Dr. Montastruc’s research is in the area of pharmacovigilance and pharmacoepidemiology which involves the signal detection and studying the risks of medications in the population at large and in the real world setting of clinical practice. Research topics focus in particular on the use and risks of psychotropic drugs. He teaches medical pharmacology and drug-related harm at the University of Toulouse.
He works as an expert member of pharmacovigilance for the French drug agency (ANSM). Since March 2020, he has been a member of the COVID-19 drug monitoring committee for the French Drug Agency (ANSM).
Dr Daniel Morales, is a senior clinical epidemiologist within the Data Analytics and Methods Taskforce at the European Medicines Agency (EMA). Until recently he was a European Commission appointed Independent Scientific Expert to the Pharmacovigilance Risk Assessment Committee and member of the EMA Pandemic Emergency Task Force. Dr Morales has a background in clinical general practice and academia at the University of Dundee.
Lembit Rägo (MD, PhD) was Professor of Pharmacology and Clinical Pharmacology at Tartu University from 1983-1999. He was the first Director-General of the Estonian regulator, State Agency of Medicines, during 1991-1999. In December 1999 he joined the WHO Headquarters in Geneva as Coordinator of the Quality Assurance and Safety of Medicines (QSM) team.
In September 2013 he was appointed as Head of the newly formed WHO unit for Regulation of Medicines and Other Health Technologies, which combined all regulatory activities for medicines, vaccines and diagnostics. During 2000-2016 he served as a WHO observer to ICH Steering Committee and as a Board Member of the Uppsala Monitoring Centre (UMC). Since 2016 he is the Secretary-General of the Council for International Organizations of Medical Sciences (CIOMS). In 2018-2019 he was a member of U.S. National Academies of Sciences, Engineering, and Medicine Committee on Mutual Recognition Agreements in the Regulation of Medicines.
Christophe Richez, MD, PhD, works in the Rheumatology Department at Hôpital Pellegrin and is affiliated with the Immuno ConcEpT Lab CNRS UMR 5164 at the University of Bordeaux, Bordeaux, France. He is Head of the National Reference Center RESO for rare autoimmune systemic diseases, and the Club Rhumatismes et Inflammation.
Professor Richez gained his medical degree, specialising in rheumatology, at Bordeaux University. After a research scholarship at Boston University, USA, he returned to Bordeaux where he became a Fellow in Rheumatology at Pellegrin Hospital and then received a PhD, a Specialisation in Clinical Immunology, and an HDR, France’s highest university diploma. His main research interests are translational research on the role of different actors, such as selectins, Tfh, Tph and others, in the pathogenesis of systemic lupus erythematosus. His clinical research focuses on treatment strategy in rheumatoid arthritis (RA), notably with 2 ongoing clinical trials on combination of metformine and methotrexate in early RA, and combination of baricitinib and adalimumab in refractory RA.
Professor Richez is a member of the scientific committee of major French rheumatology societies including the Société Française de Rhumatologie, FAI2R, GR2, and Fondation Arthritis. He was a member of the editorial teams for Annals of Rheumatic Diseases, Joint Bone Spine, and Rheumatology Advances in Practice, and is a manuscript reviewer for several journals. He was also one of the organiser of the EULAR Immunology course.
In addition, he is occasional expert for the ANSM, and was involved in the recommendations of the PRAC dedicated to the safety of JAK inhibitors.
Gerard Rongen is internist, Clinical Pharmacologist and specialist in Vascular Medicine since 2000 at Radboudumc, Nijmegen, the Netherlands. His research themes included purine pharmacology, ischemia-reperfusion injury, hypertension and hyperuricemia. He is professor in Translational Cardiovascular Research. In addition, he has been active in the Medical Ethics Review Board of Arnhem/Nijmegen, has been member of the Central Ethics Committee in the Netherlands as Clinical Pharmacologist and currently chairs the Medical Ethical Review Board-East Netherlands. He is currently president-elect of the European Association of Clinical Pharmacology and Therapeutics (EACPT) and will chair EACPT from July 1 2023-2025.
Elena works as Associate Professor in Pharmacy at the Faculty of Health Sciences, at Oslo Metropolitan University. Her research specialises in issues at the interface between scientific evidence, practice, policy and philosophy. She has a multi-disciplinary background that includes Pharmacy (MSc), Molecular Medicine (PhD) and Philosophy/Ethics of Science (post-doctoral experience and collaborative research). She is particularly interested in responsible science-based decision-making with focus on risk and safety of medicines, both from a practical, methodological and philosophical perspective. As part of this she works on expert disagreement, and the influence of philosophical basic assumptions in evidence production and evaluation. She is also interested in educating young practitioners and researchers to interdisciplinarity and to introduce patient-centeredness in pharmacy education.
I have been the PI of the project ‘Causation, Probability and Complexity in Pharmacovigilance‘ (2018-2021,CauseHealth Risk and Safety), financed by the WHO-collaborating centre Uppsala Monitoring Centre for global drug safety (Pharmacovigilance).
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).
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.
In 2015 he attended a post-doc fellowship at the Centre for Clinical Epidemiology, Lady Davis Institute, Jewish General Hospital, McGill University (Montreal, Canada). 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. Since 2022 he is co-chair of the Scientific Board of the ISoP. He is the author of about 110 articles in peer reviewed scientific journals.
Eugène van Puijenbroek is a medical doctor and clinical pharmacologist who has been working at the Netherlands Pharmacovigilance Centre Lareb since 1994. In 2001 he obtained a PhD degree at the Department of Pharmacotherapy and Pharmacoepidemiology at the Utrecht Institute for Pharmaceutical Sciences, University of Utrecht, the Netherlands. Since April 2014 he is professor of pharmacovigilance at the Faculty of Science and Engineering, Department of PharmacoTherapy, -Epidemiology and -Economics of the University of Groningen, the Netherlands. He obtained a vast experience analysing signals in the spontaneous reporting system of the Netherlands and published in national as well as international journals. Next to his work in pharmacovigilance he has been working as a general practitioner from 1991 till 2006.
His current field of attention is the development of signal detection methodologies, especially the integration of the statistical approach combined with the use of clinical information. He was a member of the Executive Board of the International Society of Pharmacovigilance from 2006 till 2012 and is currently member of the ISoP Scientific Board. He was co-opted member of the Pharmacovigilance Working Party of the European Medicines Agency from 2010 till 2012. He is a member of the editorial board of Drug Safety since 2001 and Chair of the Signal Management Review Technical Working Group Methods Work stream of the European Medicines Agency.
Eugène van Puijenbroek has been coordinating national and international studies focussing on the safety of drugs. He coordinated postgraduate training courses on pharmacovigilance and supervises several PhD students working in the field of Drug Safety.
Researcher Post-Doc at the Netherlands Comprehensive Cancer Organisation (IKNL)
Van den Hurk dedicated her career to adverse events of cancer treatments and supportive care to manage toxicities. At IKNL, she is currently conducting randomized trials and observational studies on monitoring patient-reported symptoms, using real world data collection in a sustainable infrastructure.
Van den Hurk is board member of the Prospective Renal Cell Cancer (PRO-RCC) Cohort with the TWIC design in which clinical data are collected in the Netherlands Cancer Registry and patient-reported outcomes in PROFILES registry. She is as well project member of the European Health Outcomes Observatories (EU H2O) lung cancer group in which core outcomes sets on clinical and patient-reported data are developed and implemented internationally.
Van den Hurk is co-chair of the Multinational Association of Supportive Cancer in Cancer (MASCC) OncoDermatology Study Group for which she supervises several international research projects on management of adverse events. At MASCC she is as well member of the membership committee and representative at the European Cancer Organisation. Besides, she is founder of the Dutch Association of Supportive Cancer in Cancer (DASCC) and member of the Dutch Epidemiology Society (NvE), and the Dutch Society for Psycho-social Oncology (NVPO).
Dr. Teun van Gelder is an internist-nephrologist / clinical pharmacologist. He was trained in internal medicine and nephrology at the Erasmus Medical Center, and completed his thesis in 1996 on the use of anti-interleukin-2 receptor monoclonal antibodies in solid organ transplantation. As a post-doctoral scientist, he worked in the Transplantation Immunology Laboratory of Dr. Randall E. Morris at Stanford University (1998-2000).
Between 2000 and 2019 he worked in the Departments of Hospital Pharmacy and Internal Medicine at the Erasmus Medical Center in Rotterdam, the Netherlands. In 2010, at Erasmus Medical Center he was appointed Professor in Clinical Pharmacology. His research at the Erasmus Medical Center was focused on clinical pharmacology and therapeutic drug monitoring, both within the solid organ transplant field, but also beyond (oncology, psychiatry, dermatology).
In December 2019 Teun van Gelder accepted a new position in Leiden University Medical Center (LUMC). He was appointed Professor in Drug Discovery & Development. LUMC, Leiden Institute of Chemistry, Leiden Academic Centre for Drug Research (LACDR), Centre for Human Drug Research (CHDR) and Leiden Bio Science Park (LBSP) together have the expertise and facilities for the design, development and testing of new innovative drugs. This environment is unique in the Netherlands, and provides an excellent basis for drug discovery and drug development.
Rob van Marum is working as geriatrician in a large teaching hospital and holds a chair as professor of geriatric pharmacotherapy at Amsterdam UMC. Next to this, he is a member of the Dutch Medicines Evaluation Board.
In his research his focus is on medication safety for older persons.
Sarah has worked in pharmacovigilance at the UK’s Medicines and Healthcare products Regulatory Agency for the past 15 years. Her current role is the Head of Vigilance Operations, accountable for adverse incident management & signal management processes. Sarah is currently leading on the development and transformation of the Agency’s vigilance systems for all medicinal product types, engaging with strategic stakeholders in the UK healthcare system for adverse incident data collection and signal management processes.