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KIDS-APECPharmacovigilance CoE Training

Speakers

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Hyun-Joo Jung

Dr. Hyun-Joo Jung is a skilled pharmacologist from Seoul, Korea. She completed her Bachelor`s, Master`s, and PhD degrees in Pharmacy and Pharmacology at Sookmyung Women`s University. After working briefly as a researcher at Stanford University`s School of Medicine, she returned to Korea to be a postdoctoral research fellow at Yonsei University`s College of Medicine. Since 2012, Dr. Jung has been contributing her expertise to the Korea Institute of Drug Safety & Risk Management. 

 

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Eva-Lisa Meldau

Eva-Lisa Meldau is Science & Innovation Lead at the Uppsala Monitoring Centre (UMC) in Uppsala, Sweden. Previously, Eva-Lisa worked for five years as Data Scientist in UMC`s Research department where her work focused on machine learning and natural language processing. She has experience from a broad range of projects including cluster analysis of adverse event reports, evaluation of the automated coding service WHODrug Koda and AI-supported case narrative search. Eva-Lisa holds a master`s degree in computer science from the Royal Institute of Technology in Stockholm. She is passionate about the application of machine learning and artificial intelligence to problems in the field of pharmacovigilance. 

 

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Natasha Chihying Pratt

Natasha is a Master Epidemiologist at Division of Epidemiology II, Office of Pharmacovigilance and Epidemiology, Office of Surveillance and Epidemiology at Center for Drug Evaluation and Research, U.S. Food and Drug Administration (FDA). She has extensive experience in evaluating the quality of Real-World Evidence on drug safety or effectiveness to inform regulatory decision. I have led regulatory research, taught and developed guidance, and taught pre-conference courses at the International Society for Pharmacoepidemiology. Natasha is a trained pharmacist with a PhD in pharmacoepidemiology. She joined the FDA after a Post-Doctoral Fellowship in the Pharmacoepidemiology group at Brigham and Women’s Hospital/ Harvard Medical School. Her training equipped me with keen understanding of Real-World Data through hands-on experience with claims, EHR, and registries studies. 

 

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Nils Peder Tomas Bergvall

Tomas started his career at the UMC in 2009 working within the UMC research team as a Data Scientist. During the 10 years within research, he was involved externally in big collaborative projects like OMOP, PROTECT, SALUS and EHDEN. The last 5 years he has worked as a product manager for the UMC PV products portfolio to develop the support for the pharmacovigilance process worldwide.

 

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Susy Yeshika Olave Quispe

She is originally from Spain and has earned a doctorate in Pharmacy from the University of Seville, a master's degree in Bioethics and Law from the University of Barcelona, and a master's degree in Pharmacoepidemiology from the Autonomous University of Barcelona. Currently, she has 8 years of experience as a Good Clinical Practice (GCP) and Pharmacovigilance (PhV) inspector, having performed 41 PhV inspections and 23 GCP inspections on behalf of the Spanish Agency of Medicines and Medical Devices (AEMPS) and the European Medicines Agency (EMA). She has conducted PhV inspections of the pharmacovigilance systems of marketing authorization holders for both human and veterinary medicines, serving as a Lead Inspector, Inspector, and Reporting Inspector. Previously, she worked for 6 years in the Executive Support Unit / International Affairs at AEMPS, where she was responsible for coordinating cooperation activities between AEMPS and the Ibero-American Medicines Authorities Network (EAMI). Before that, she spent 5 years at the Peruvian Health Authorities, performing pharmacovigilance and clinical trial activities.

 

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Daniele Sartori

Daniele has worked for Uppsala Monitoring Centre for 10 years and is undertaking a part-time DPhil in Evidence-Based Health Care at the University of Oxford, UK. He has experience in signal management and his thesis centres around the evidence-base of signals of adverse drug reactions. His research interest are in systematic research concerning signals and their public health outcomes. He has also explored the utility of social media data and longitudinal observational healthcare data in signal detection, validation and prioritization, and evaluated methods for signal detection of drug-drug interactions.

 

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Jean-Christophe Delumeau

After graduating in medicine and neuropharmacology, then practicing in hospitals and research laboratories, Jean-Christophe Delumeau joined the pharmaceutical industry working 10 years in clinical research based in France and Switzerland, then 20 years in pharmacovigilance based successively in Japan, China and Singapore, leading regional organizations operating a broad scope of pharmacovigilance activities. In 2022, he re-oriented to not-for profit activities joining the Institute of Pharmacovigilance and serving as WHO consultant supporting Asian and African regulatory authorities strengthening their pharmacovigilance system. Jean-Christophe Delumeau joined ISoP in 2012 serving as Executive Committee member from 2016 until 2022. He is coordinating the SiG on Risk Minimisation methods.

 

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Gerald Joseph Dal Pan

Dr. Gerald Dal Pan is the Director of the Office of Surveillance and Epidemiology in the Center for Drug Evaluation and Research at the US Food and Drug Administration, where since 2005 he has been responsible for the Center’s program in pharmacovigilance, pharmacoepidemiology, medication error prevention, and risk management. In this capacity, he has been involved in multiple initiatives to advance the field of postmarket drug safety at both national and international levels. He is a member of the World Health Organization Advisory Committee on the Safety of Medicinal Products. As a medical doctor, he is trained in internal medicine, neurology, and epidemiology. 

 

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Bonggi Kim

From 2019 to the present, He is served as the Director at the Office of Pharmacoepidemiology and Big Data at KIDS. Prior to this role, He was the Manager at the Office of Pharmacoepidemiology at KIDS from 2015 to 2018. Additionally, He worked as a Researcher in the Office of Pharmacoepidemiology at KIDS from 2012 to 2014. 

 

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Priya Bahri

Priya Bahri is Senior Lead for Pharmacovigilance and Risk Management Guidance and Policy at the Priya Bahri is Senior Lead for Pharmacovigilance and Risk Management Guidance and Policy at the Pharmacovigilance Office of the European Medicines Agency (EMA). She has a degree and license in Pharmacy (University of Heidelberg), a post-graduate diploma in Epidemiology & Biostatistics (McGill University), and a PhD (Humboldt University Berlin) on quality management for patient safety. Before joining EMA in 1996, she worked in hospital and community pharmacies as well as in projects for associations of public insurance physicians and projects for the German international development agency. As pro bono activities, she affiliated researcher at the Utrecht Centre for Pharmaceutical Policy and Regulation and is active in the International Society of Pharmacovigilance (ISoP) and the International Society of Pharmacoepidemiology (ISPE). She is the editor of the book “Communicating about Risks and Safe Use of Medicines: Real Life and Applied Research”.

 

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