معرفی
Helga Gardarsdottir is a Professor in Pharmacoepidemiology at Utrecht University (Netherlands), serving as Scientific Director of the Center for Pharmacoepidemiology. She also holds an adjunct professorship at the University of Iceland and serves as a Seconded National Expert at the European Medicines Agency (EMA). Her work focuses on real-world data for regulatory decision-making, drug safety, and clinical guideline implementation. She leads international projects like IMI Trials@Home and EMA IMPACT, addressing decentralized clinical trials, risk minimization, and pharmacovigilance impact. Her roles include co-chairing the ENCePP steering group and editing Pharmacoepidemiology & Drug Safety. Beyond research, she chairs the Faculty of Science’s EDI committee, promoting inclusive academic practices.
Education: Pharmacist training in Sweden; Pharmacoepidemiology specialization in the Netherlands.
Research Interests: Innovations in real-world evidence generation, regulatory science, drug safety surveillance, and clinical trial modernization. Key areas include RWE’s role in HTA/regulatory decisions, unintended impacts of drug policies, and digital health integration.
Publications: Recent work emphasizes methodological advancements in decentralized trials, pharmacovigilance outcomes (e.g., fluoroquinolone prescribing shifts), and harmonized approaches to external control trials. Her studies bridge regulatory practices with clinical practice guideline adherence.
Achievements: Overseeing multi-country initiatives like the IMI Trials@Home consortium (decentralized trials framework) and EMA IMPACT (guideline-RMM integration). Recognized for leadership in ENCePP’s methodological standards and ISPE’s Real-World Evidence Task Force.
Grants & Teams: Principal investigator on EMA-funded projects and IMI grants. Leads Utrecht’s Applied Data Science initiative and collaborates with the EU PEV Research Network. Active in training next-generation researchers through teaching and mentoring.
Labs/Teams: Utrecht Center for Pharmaceutical Policy & Regulation; Trials@Home consortium; ENCePP working groups.
