ISoP Mid-Year Symposium

Ulla Wändel Liminga is a pharmacist and has a Doctoral thesis in Medical Sciences from Uppsala University in Sweden. In 1994, she started at the Swedish Medical Products Agency, as a non-clinical assessor. She has since then worked with non-clinical as well as clinical efficacy and safety assessments. In 2007, she became Scientific Director of Pharmacology and Toxicology at the Swedish Agency. From March 2020, her position has changed to Scientific Director Pharmacovigilance. From July 2012, she has also been one of the Swedish members of the Pharmacovigilance Risk Assessment Committee (PRAC) at the European Medicines Agency (EMA).
In July 2024, she was elected chair person for the PRAC, and started her mandate in the beginning of September 2024.

Dr. Sara Riggare is a patient researcher at Uppsala University, specializing in participatory eHealth and patient-led research in chronic disease management. Diagnosed with Parkinson’s disease in early adulthood, she applies personal science to optimize pharmaceutical treatment and selfcare. Her research has implications for the integration of patient-generated health data into pharmacovigilance and healthcare decision-making. Dr. Riggare earned her PhD from Radboud University with a dissertation on patient-led research in Parkinson’s disease. A recognized advocate for patient engagement in medicine, she serves on the British Medical Journal’s Patient Panel and has been honored for her contributions to healthcare innovation.

Mikael Hoffmann, MD PhD MPH
Physician, specialist in clinical pharmacology and infectious diseases.
Member of the executive committee of the Swedish Society of Medicine and chairman of the committee for pharmaceutical policy.
Member of the Scientific Advisory Board for Human Medicine at the Swedish Medical Products Agency 2008–2025
CEO of the NEPI foundation initiated by the Swedish Parliament to support and promote pharmacoepidemiology, 2007–2025
Director of pharmaceutical policies at the County Council of Östergötland, including Chief Medical Information Officer responsible for the electronic patient record 2000–2011
Mikael Hoffmann is a physician specialized in infectious diseases and clinical pharmacology and responsible for the pharmaceutical policies for the Swedish Society of Medicine. He has been a member of the scientific advisory board of the Swedish Medical Products Agency since 2008 and CEO of the NEPI foundation initiated by the Swedish Parliament to support and promote pharmacoepidemiology since 2007. Previously he held a position as head of department at Linköping University Hospital and was responsible for the implementation and management of the county-wide electronic patient record as a chief medical information officer.
Linkedin https://www.linkedin.com/in/mhoffmann1/

Dr Henry Zakumumpa is based at Makerere University in Uganda. Henry’s PhD focused on HIV treatment delivery in Uganda, a resource-constrained setting. Henry is interested in pharmacovigilance research relating to new HIV therapies. Between 2020 and 2022, he undertook a study to understand the safety of the newly introduced dolutegravir (DTG)-based HIV treatment in Ugandan populations with funding from Uppsala Monitoring Centre. From 2022 to 2023, Henry was part of the investigator team evaluating a novel peer support intervention for enhancing the involvement of recipients of HIV care in reporting of ADRs in Uganda.This was a WHO-funded study. In 2024, Henry together with co-investigators from the National Pharmacovigilance Centre of Uganda investigated drivers of data quality in the reporting of adverse drug reactions in Ugandan HIV clinics in a study funded by Uppsala Monitoring Centre.

Omar Aimer is a seasoned safety professional and global pharmacovigilance leader based in Montreal, Canada. He serves as an Executive Committee member and Treasurer of the International Society of Pharmacovigilance (ISoP), Leader of the Medical Device Safety Special Interest Group (SIG), and President of the North American Chapter of ISoP (NASoP).
With leadership experience in regulatory and academic environments, as well as in pharmaceutical companies across Europe and Canada, he brings a comprehensive perspective to drug safety. Omar holds a degree in Pharmacy, a PhD in Pharmacology, and a Master’s in Pharmacovigilance and Drug Safety.
A frequent presenter at scientific forums, he is committed to advancing pharmacovigilance through the adoption of innovative technologies and the enhancement of global drug safety practices.

Houda Sefiani, MD, PhD
Medical doctor specializing in pharmaco-toxicology, with a PhD in Health Vigilances.
Currently serving as the Director of the Moroccan Poison Control and Pharmacovigilance Centre (CAPM).
Member, WHO International Working Group for Drug Statistics Methodology.
Vice president of the Rabat Collaborating centre
Vice president of the Moroccan society of pharmacovigilance and patient safety (SMPS)
Scientific Committee Member, ISoP Middle East Chapter.

Michele Fusaroli, MD, PhD, serves as a Senior Pharmacovigilance Scientist at the Uppsala Monitoring Centre’s Research Department. He steered the READUS_PV group, which focused on establishing reporting guidelines for disproportionality analysis. Fusaroli Michele has implemented innovative pharmacovigilance methods, such as using network analysis to study reactions as syndromes. He is also an advocate for open-source practices, having developed R packages like DiAna for cleaning and analyzing FAERS data, and PV-dagger for examining biases in disproportionality analysis. Currently, he is dedicated to advancing the appropriate and qualified use of adverse event reports.

Prof. dr. Agnes Kant is professor in innovation of Pharmacovigilance, 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 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. Michael Forstner has 25 years industry experience in various roles in R&D and drug safety in different pharmaceutical companies and as a consultant and has contributed to several successful marketing authorizations of innovative medicines by developing workable, efficient benefit-risk management measures, mostly in the oncology and CNS therapeutic areas. He is currently driving the utilization of RWE in pharmacovigilance processes, as well as methodologies to develop and maintain favourable benefit-risk frameworks informed by patient preferences., and graphical representations of risks associated with ADRs to enable improved patient decision making.

Dr Peter Arlett is Head of the Data Analytics and Methods Taskforce at the European Medicines Agency. In this role he leads on operations and transformation on clinical evidence at the EMA including clinical trials, real world evidence, safety reporting and data science including AI. He is Chair of the EMA Data Board, Co-Chair of the HMA-EMA Network Data Steering Group, Co-chair of the EMA AI Coordination Group, Co-chair of the Vaccine Monitoring Platform Steering Group, and Member of the ACT EU Steering Group. Prior to taking up this role in 2020, he held leadership roles within the EMA in the areas of pharmacovigilance, epidemiology, and risk management.

Prior to starting at EMA in 2008, Peter worked on new legislation and international collaboration for the European Commission, was the UK delegate to the European Committee for Human Medicinal Products, and was an assessor and manager at the UK’s MHRA. He has a medical degree from University College London, and began his career as a hospital physician in Oxford and London.

In addition to his role at EMA, Peter is Honorary Professor at the London School of Hygiene and Tropical Medicine. He is also a Fellow of the Royal College of Physicians of Edinburgh and of the Faculty of Pharmaceutical Medicines of London.

Björn Wettermark, M.Sc.Pharm, PhD is professor of pharmacoepidemiology at Uppsala university, Sweden and visiting professor at Vilnius university, Lithuania. His research focus on drug utilization as a tool in health policy including prescribing quality indicators, international comparisons of drug utilization, evaluation of prescribing doctors´ adherence to guidelines, evidence generation for new medicines and patient adherence to treatment. He has previously had various managerial positions in the health region of Stockholm as well as other commitments including membership in national and regional strategic groups on medicine management, scientific advisor to the Swedish Medical Products Agency and chair of the European Drug Utilization Research group (EuroDURG), the European chapter of the International Society for Pharmacoepidemiology.

Sabine Koch is the Strategic Professor of Health Informatics at Karolinska Institutet in Stockholm, Sweden, Head of the Department of Learning, Informatics, Management and Ethics (LIME) and Head of the Health Informatics Centre. Dr. Koch received both a M.Sc. and a Ph.D. degree in Medical Informatics from Ruprecht-Karls University Heidelberg, Germany. Her early research was in dental informatics, especially dental imaging and IT supported integrated care concepts for dental offices. Her fields of interest include models for collaborative care, especially homecare, human factors/ usability and evaluation of information systems. Current research concerns a socio-technical perspective on integrating health, social and selfcare but also guideline-based clinical decision support and information visualization for enhanced decision making. Dr. Koch is the Past President of the International Medical Informatics Association (IMIA) and Editor-in-Chief of Methods of Information in Medicine. She is a frequent member of the Scientific Program Committees for different international conferences in the field, associate editor of Applied Clinical Informatics and member of the editorial board of the International Journal of Medical Informatics. She also acted as external expert for EC DG SANTE – Assessing the impact of digital transformation of health services.

Niklas Norén is Chief Science Officer at the Uppsala Monitoring Centre, the WHO Collaborating Centre for International Drug Monitoring, and a member of its executive management team since 2009. He has published extensively on statistical pattern discovery in observational medical data, primarily adverse event reports and electronic medical records. His research has resulted in scientific papers on duplicate detection and subgroup discovery that have been internationally awarded. He is a member of the editorial board for Drug Safety, and he has led several international collaborative projects in pharmacovigilance including the signal detection work-package in IMI PROTECT; the work-packages on detecting substandard medicines and drug dependence in Monitoring Medicines; and the social media analytics work-package in IMI WEB-RADR. He is a member of the CIOMS XIV working group on Artificial Intelligence in Pharmacovigilance. Niklas holds a PhD in Mathematical Statistics from Stockholm University in 2007 and a MSc in Engineering Physics from Chalmers University of Technology in 2002.

Andrew Bate PhD
VP & Head, Safety Innovation & Analytics, GSK
Andrew is Vice President & Head of Safety Innovation & Analytics at GSK and leading the development of next generation Safety capability and a member of the Global Safety Leadership team. Previously Andrew was in the Global Epidemiology Leadership team at Pfizer for a decade and prior to that at the WHO Collaborating Centre for International drug Monitoring (the Uppsala Monitoring Centre) for more than 12 years, where he led the Research function.

He was previously a member of the Executive Committee of ISoP and was chair of the Education and Training Programme. Currently, Andrew sits on the Transcelerate BioPharma Pharmacovigilance Steering Committee and Integrated Leadership Team for GSK and was their Executive Sponsor of the Intelligent Automation initiative and the existing co-sponsor of the Modernizing Pharmacovigilance workstream. Andrew is a member of CIOMS XIV on Artificial Intelligence in Pharmacovigilance. Andrew has over the last 25 years over 100 peer reviewed scientific publications many related to AI, and has held or holds several academic positions.

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).

Daniele is a senior pharmacovigilance scientist at Uppsala Monitoring Centre and a candidate for a DPhil in Evidence-Based Health Care at the University of Oxford. He has over 10 years of experience in pharmacovigilance, focusing on signal detection, regulatory decision-making, and international harmonization of reporting practices. He has co-authored papers on statistical methods for signal detection, systematic literature reviews, and Delphi studies. Recently, he has been researching how product information guides healthcare professionals in preventing or mitigating adverse drug reactions.

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.

Peter Hjelmström is the Director/CEO of Uppsala Monitoring Centre (UMC), the World Health Organisation (WHO) Collaboration Centre for the Programme for International Drug Monitoring. Peter is physician and scientist, with MD and PhD degrees from Karolinska Institutet, and he did his postdoctoral fellowship at Yale University. He was an associate professor and trained as an orthopedic surgeon at Karolinska University Hospital before working in the pharmaceutical industry for 17 years. His most recent role before joining UMC in 2023 was as Chief Medical Officer at a Swedish pharmaceutical company. He has published over 45 manuscripts in peer-reviewed scientific journals mainly within immunology, as well as pharmacoepidemiology of opioid dependence.

Dr Edwards trained as a medical doctor at Guy’s Hospital, London and spent 14 years in hospital medicine and clinical research before joining the UK regulatory agency which used to be called the Medicines Control Agency. After 5 years there, he joined a global CRO, Parexel, for six years followed by 18 months at Johnson & Johnson as a deputy qualified person for pharmacovigilance.
For 13 years up until 2021, he was Principal Consultant in Pharmacovigilance at NDA Regulatory Science based in the UK.
In addition, he co-chairs the ISOP Medication Error Special Interest Group) and Chair of the UK Pharmaceutical Human Factors group.
Previously, he chaired the panel overseeing the ‘Drug Safety Surveillance’ module as part of Higher Medical Training for pharmaceutical medicine in the UK between January 2006 and 2012. He was awarded a Fellowship with the International Society of Pharmacovigilance.
Currently he is Managing Director of his own consultancy Husoteria Ltd and has been co-leader of the DIA/ASA Benefit Risk Assessment Planning working group since 2020. He was elected back to the Executive Committee of ISOP in 2022 and is Vice-President of ISOP and Director of ISOP Secretariat Ltd.
In May 2023 he was awarded a Global Fellowship in Medicines Development.
He is the Co-Chair of the Scientific Committee for ISoP 2025 Cairo.

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. From August 2009 to October 2024 he worked as Pharmacovigilance Manager at the Unit of Adverse Drug Reactions Monitoring of the University Hospital of Pisa. In this period, he was one of the coordinators of the Tuscan Regional Centre of Pharmacovigilance. He was also free-of-charge professor for several courses (e.g. Pharmacovigilance, Evidence based medicine and communication about drugs and vaccines) at the department of Pharmacy of the University of Pisa, and courses in post-graduate schools at the department of Clinical and Experimental Medicine of the University of Pisa. In November 2024 he started a new position of Associate Professor of Pharmacology at the Department of Diagnostic and Public Health of the University of Verona. He collaborates with the Agenzia Italiana del Farmaco (AIFA) as member of the Working Group for Signal Detection Analysis on Drugs and Vaccines. He is also co-chair of the scientific board of the International Society of Pharmacovigilance (ISoP) and coordinator of the ISoP European Chapter. 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). He is the author of about 130 articles, mainly on topics of Pharmacovigilance and Pharmacoepidemiology in peer reviewed scientific journals and several chapters on books.

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.

Qun-Ying Yue is a Medical Doctor and specialist in Clinical Pharmacology. She holds a PhD and Associate professorship from Karolinska Institute, Sweden. She is a Senior Pharmacovigilance Expert at the Uppsala Monitoring Centre (UMC), Sweden. Prior to joining the UMC, she worked as Senior expert in Pharmacovigilance at the Swedish Medical Products Agency, where among other responsibilities she served as a member of the Pharmacovigilance Risk Assessment Committee (PRAC) at the European Medicines Agency (EMA)) for a number of years. She has a special interest in pharmacogenetics which has been the focus of her research work. She was a member of the Pharmacogenomic Working Party at EMA for 10 years in the past and currently is the chairperson of the Pharmacogenomics (PGx) Special Interest Group (SIG) of International Society of Pharmacovigilance (ISOP). She has been awarded a Fellowship with ISoP.

Mónica is a clinical pharmacologist trained in pharmacovigilance. She achieved her medical degree in her home country -Ecuador- and holds a PhD. degree in Clinical Pharmacology from the Autonomous University of Barcelona. Mónica has worked in multidisciplinary groups to identify post-marketing drug safety signals at national and international level.
Since returning to Ecuador, she has worked as a lecturer of Basic and Clinical Pharmacology in some Ecuadorian universities. Monica has also served on several national committees, including the external expert panel of the Ecuadorian Regulatory agency (ARCSA) and the National Commission of Medicines in Ecuador (CONAMEI). Internationally, she has worked as a consultant for the Pan-American Health Organization and is part of the external expert panel of the Brazilian Health Regulatory Agency (ANVISA). She was part of the previous term of the ISoP Advisory Board (2019-2022).
Currently, she works as a consultant -based in Ecuador- for the Uppsala Monitoring Centre (Education and training section/Signal management team).

Linda Härmark, PharmD, PhD, epidemiologist, MBA
Dr. Linda Härmark is a pharmacist and epidemiologist by training, and has more than 20 years experience in pharmacovigilance. The past four years she was the deputy director of the Netherlands Pharmacovigilance Centre Lareb. As of April this year she joined the Drug Safety Research as its new director. She has (co)-authored more than 40 peer-reviewed papers in the field of pharmacovigilance.

Fredrik Brounéus is a communications officer at Uppsala Monitoring Centre. Over the past 25 years, he has worked with public engagement, citizen science, communication, and research in the public, academic, private and non-governmental sector in Sweden and New Zealand. He is a pharmacist with a master’s degree in journalism from Uppsala University. At Uppsala Monitoring Centre, he is part of the teams behind the annual #MedSafetyWeek campaign and the Drug Safety Matters podcast.