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KIDS-APECPharmacovigilance CoE Training

Our speakers

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Sun Mi Shin, PhD

Sun Mi Shin, RPh, PhD

Director, Office of Drug Safety Information
Department of Drug Safety Information
Korea Institute of Drug Safety and Risk Management (KIDS)
Republic of Korea

Sun Mi joined KIDS in 2012. Ever since she worked in various positions mainly for the development of drug utilization review criteria and signal detection. Now she manages the collection and management of adverse event reports, signal detection and evaluation, and operation of Regional Pharmacovigilance Centers as the director of the office of drug safety information. She earned a PhD in Social Pharmacy from Sungkyunkwan University, Master’s and Bachelor degrees in Pharmacy from the Seoul National University.
Lucie Gattepaille, PhD

Lucie Gattepaille, PhD

Head of Data Science
Uppsala Monitoring Centre (UMC)
Sweden

Now heading the Data Science section at UMC, Lucie first started as a data scientist in 2016. As a data scientist, she has been focusing on extracting meaningful information about drug safety from different data sources, including social media. Before joining the UMC on its journey to advance the science of pharmacovigilance and improve patient safety worldwide, she did a PhD in population genetics at Uppsala University, where she developed and applied mathematical models to study human evolution using genetic data.
Selected publications Gattepaille, L. M., Vidlin, S. H., Bergvall, T., Pierce, C. E., & Ellenius, J. (2020). Prospective Evaluation of Adverse Event Recognition Systems in Twitter: Results from the Web-RADR Project. Drug Safety, 14.

Caster, O., Aoki, Y., Gattepaille, L. M., & Grundmark, B. (2020). Disproportionality analysis for pharmacovigilance signal detection in small databases or subsets: recommendations for limiting false-positive associations. Drug Safety, 43(5), 479-487.

Dietrich, J., Gattepaille, L. M., Grum, B. A., Jiri, L., Lerch, M., Sartori, D., & Wisniewski, A. (2020). Adverse Events in Twitter-Development of a Benchmark Reference Dataset: Results from IMI WEB-RADR. Drug safety, 1-12.

Gattepaille, L. M. (2019, June). Using the WHO database of spontaneous reports to build joint vector representations of drugs and adverse drug reactions, a promising avenue for pharmacovigilance. In 2019 IEEE International Conference on Healthcare Informatics (ICHI) (pp. 1-6). IEEE.

Gattepaille, L., Günther, T., & Jakobsson, M. (2016). Inferring past effective population size from distributions of coalescent times. Genetics, 204(3), 1191-1206.
Gerald Dal Pan, MD, MHS

Gerald Dal Pan, MD, MHS

Director, Office of Surveillance and Epidemiology
Center for Drug Evaluation and Research (CDER)
U.S. Food & Drug Administration (U.S. FDA)
United States of America

Gerald currently serves as the Director of the Office of Surveillance and Epidemiology in FDA’s Center for Drug Evaluation and Research, where since 2005 he has been responsible for the Center’s programs in adverse event surveillance and analysis, pharmacoepidemiology, risk management, and medication error prevention. In this capacity, he is involved in both the premarket and postmarket regulation of drugs and therapeutic biologics, and in the implementation of the drug safety provisions of the Food and Drug Administration Amendments Act and other initiatives. He is a member of the World Health Organization Advisory Committee on the Safety of Medicinal Products, and has served on working groups of the Council of International Organization of Medical Sciences (CIOMS) and the International Council on Harmonisation (ICH). He received his MD from Columbia University College of Physicians and Surgeons and his Master of Health Science in Clinical Epidemiology from the Johns Hopkins University School of Hygiene and Public Health. He completed residency training in Internal Medicine at the Hospital of the University of Pennsylvania and in Neurology at the Johns Hopkins Hospital. He is board certified in both Internal Medicine and Neurology. He joined FDA in 2000 as a medical reviewer in the Center’s Office of New Drugs. Before working at FDA, he was a faculty member in the Department of Neurology at Johns Hopkins and worked in the pharmaceutical industry. Selected publications Schneeweiss S, Rassen JA, Brown JS, Rothman KJ, Happe L, Arlett P, Dal Pan G, Goettsch W, Murk W, Wang SV. Graphical Depiction of Longitudinal Study Designs in Health Care Databases. Ann Intern Med. 2019 Mar 19;170(6):398-406. doi: 10.7326/M18-3079. Epub 2019 Mar 12.

Harinstein L, Kalra D, Kortepeter CM, Muñoz MA, Wu E, Dal Pan GJ. Evaluation of Postmarketing Reports from Industry-Sponsored Programs in Drug Safety Surveillance. Drug Saf. 2019 May;42(5):649-655. doi: 10.1007/s40264-018-0759-7.

Kesselheim AS, Sinha MS, Rausch P, Lu Z, Tessema FA, Lappin BM, Zhou EH, Dal Pan GJ, Zwanziger L, Ramanadham A, Loughlin A, Enger C, Avorn J, Campbell EG. Patients' Knowledge of Key Messaging in Drug Safety Communications for Zolpidem and Eszopiclone: A National Survey. J Law Med Ethics. 2019 Sep;47(3):430-441. doi: 10.1177/1073110519876176.

Mohamoud M, Patanavanich S, Crew P, McCulley L, Munoz M, Kortepeter C, Jones SC, Woronow D, Dal Pan G. Discontinuation of Direct Oral Anticoagulants in Response to Attorney Advertisements: Data From the FDA Adverse Event Reporting System. Ann Pharmacother. 2019 Sep;53(9):962-963. doi: 10.1177/1060028019849664. Epub 2019 May 5.

Muñoz MA, Dal Pan GJ. The Impact of Litigation-Associated Reports on Signal Identification in the US FDA's Adverse Event Reporting System. Drug Saf. 2019 Oct;42(10):1199-1201. doi: 10.1007/s40264-019-00834-1.

Muñoz MA, Delcher C, Dal Pan GJ, Kortepeter CM, Wu E, Wei YJ, Xiao H, Winterstein AG. Pharmacotherapy. 2019 Nov;39(11):1042-1052. doi: 10.1002/phar.2325. Epub 2019 Oct 11. Impact of a New Consumer Form on the Quantity and Quality of Adverse Event Reports Submitted to the United States Food and Drug Administration.

Kesselheim AS, Sinha MS, Campbell EG, Schneeweiss S, Rausch P, Lappin BM, Zhou EH, Avorn J, Dal Pan GJ. Multimodal Analysis of FDA Drug Safety Communications: Lessons from Zolpidem. Drug Saf. 2019 Nov;42(11):1287-1295. doi: 10.1007/s40264-019-00849-8.

Muñoz MA, Dal Pan GJ, Wei, Y-JJ, Delcher C, Xiao H, Kortepeter CM, Winterstein AG. Towards Automating Adverse Event Review: A Prediction Model for Case Report Utility. Drug Saf. 2020 Apr;43(4):329-338. doi: 10.1007/s40264-019-00897-0. PMID: 31912439.

Marwitz K, Jones SC, Kortepeter CM, Dal Pan GJ, Muñoz MA. An Evaluation of Postmarketing Reports with an Outcome of Death in the US FDA Adverse Event Reporting System. Drug Saf. 2020 May;43(5):457-465. doi: 10.1007/s40264-020-00908-5. PMID: 31981082.

Geller AI, Zhou EH, Budnitiz DS, Lovegrove MC, Dal Pan GJ. Changes in emergency department visits for zolpidem-attributed adverse drug reactions after FDA Drug Safety Communications. Pharmacoepidemiol Drug Saf. 2020 Mar;29(3):352-356. doi: 10.1002/pds.4952. Epub 2020 Jan 9. PMID: 32483401.

Bulatao I, Pinnow E, Day B, Cherkaoui S, Kalaria M, Brajovic S. Dal Pan G. Postmarketing safety-related regulatory actions for new therapeutic biologics approved in the U.S. 2002 - 2014: Similarities and differences with new molecular entities. 2020 Jun 17. doi: 10.1002/cpt.1948. Online ahead of print. PMID: 32557564.
Yun Hui Do, RPh, MPH

Yun Hui Do, RPh, MPH

Clinical Associate
Medical Team/Customer Operation
MedDRA MSSO
Republic of Korea

Yun Hui works as a Clinical Associate for the MedDRA MSSO with responsibility for conducting MedDRA training and providing help desk services and other support in the Republic of Korea. She was a Researcher/Assistant Manager at Korea Institute of Drug Safety & Risk Management (KIDS) from 2015 to 2018. She was mainly involved in methodological research in pharmacovigilance and signal detection and assessment in the Office of Drug Safety Information. In 2018, She was dispatched to the affiliate governmental organization, the Korean Ministry of Food and Drug Safety, to engage in a project to develop a new integrated drug information management system. Prior to pursuing the Master of Public Health, she worked as a clinical pharmacist in Changwon Fatima Hospital as well.
Jan Petracek, MD, MSc, DIC, FISoP

Jan Petracek, MD, MSc, DIC, FISoP

Director, Institute of Pharmacovigilance
Advisory Board, International Society of Pharmacovigilance
Czech Republic

Jan qualified as a physician from Charles University in Prague and holds a Master of Science with Distinction in Quality and Safety in Healthcare from Imperial College London. Jan has over 20 years of experience in all areas of pharmacovigilance, being former Head of Risk Management Section at European Medicines Agency, Head of Pharmacovigilance in the Czech Republic, Head of Strategy and Development of the Czech National Authority, and member of CHMP Pharmacovigilance Working Party.

He was trained as the inspector within the Benchmarking of the European Medicines Authorities, assessing performance of regulatory authorities in the EU and helping to set benchmarks for regulatory approaches and performance. He participated in development of several national, European, ICH and CIOMS guidelines. He was the lead author of the EMA Guideline on Safety and Efficacy Follow-up - Risk Management of Advanced Therapy Medicinal Product, and member of the ICH E2F Expert Working group on Development Safety Update Reports. He contributed to development of new regulatory pathways as a member of the EMA Innovation Taskforce, including biosimilars, nano medicines, and challenging combination products.

Jan is a very active trainer at international courses, and is an elected member of the Advisory Board - International Society of Pharmacovigilance (ISoP). He also worked as EU QPPV for major innovative companies, performed complex audits, strategic consultancy, and led fast growing organisations as entrepreneur and CEO for the last 10 years.
Ruth Savage, MD, MSc

Ruth Savage, MD, MSc

Consultant/Medical Advisor
Research and Education
Uppsala Monitoring Centre (UMC)
Sweden

Ruth is a graduate of the University of Newcastle upon Tyne, United Kingdom. She has been a Consultant and Medical Advisor for the Uppsala Monitoring Centre, WHO Collaborating Centre for International Drug Monitoring, over the last 20 years primarily in signal detection and associated research and in international pharmacovigilance training. As part of the UMC Signal Editorial Team she has recently been involved with COVID-19 vaccine monitoring. Ruth is also a Senior Medical Assessor in the New Zealand Pharmacovigilance Centre and Senior Lecturer in General Practice in the University of Otago, Christchurch, New Zealand. Her clinical career has been predominantly in rural general practice with some experience in internal medicine and rheumatology. Selected publications Savage RL, Hill GR, Barnes J et al. Suspected hepatotoxicity with a supercritical carbon dioxide extract of Artemisia annua in grapeseed oil used in New Zealand. Frontiers in Pharmacology. 2019; 10: doi: 10.3389/fphar.2019.01448.

Hegerius A, Caduff-Janosa P, Savage R, Ellenius J. E-learning in pharmacovigilance: an evaluation of microlearning-based modules developed by Uppsala Monitoring Centre. Drug Safety. 2020; 11: 1171-1180.
Steven Anderson, PhD, MPP

Steven Anderson, PhD, MPP

Director, Office of Biostatistics and Epidemiology
Center for Biologics Evaluation and Research (CBER)
U.S. Food & Drug Administration (U.S. FDA)
United States of America

Steven is currently the Director of the Office of Biostatistics and Epidemiology (OBE) at the FDA Center for Biologics Evaluation and Research (CBER). He provides leadership for all CBER statistical, epidemiological and surveillance programs and has led numerous important surveillance and epidemiological studies and quantitative benefit-risk assessments of vaccines, tissues, and blood products using systems such as VAERS (Vaccine Adverse Event Reporting System), the Biologics Effectiveness and Safety (BEST) initiative - CBER’s new surveillance system, the FDA Sentinel and CMS data. Steven earned a Master’s Degree in Public Policy (MPP) at Georgetown University and a PhD from the University of Cincinnati where he worked in the areas of biochemistry, drug resistance and ion pumps, pathogenicity and genomics of infectious pathogens. He has published a number of articles in biologic product safety, surveillance, quantitative risk assessment, epidemiology, infectious diseases, biologics safety, and genomics. Selected publications Whitaker BI, Belov A, Anderson SA. Progress in US hemovigilance: can we still learn from others? Transfusion. 2019 Feb;59(2):433-436.

Forshee RA, Hu M, Arya D, Perez-Vilar S, Anderson SA, Lo AC, Swarr M, Wernecke M, MaCurdy T, Chu S, Kelman J. A simulation study of the statistical power and signaling characteristics of an early season sequential test for influenza vaccine safety. Pharmacoepidemiol Drug Saf. 2019 Aug;28(8):1077-1085.

Huang Y, Anderson SA, Forshee RA, Yang H.Huang Y, et al. A modified dose-response model that describes the relationship between haemagglutination inhibition titre and protection against influenza infection. J Appl Microbiol. 2018 Jan;124(1):294-301.

Sherman RE, Anderson SA, Dal Pan GJ, Gray GW, Gross T, Hunter NL, LaVange L, Marinac-Dabic D, Marks PW, Robb MA, Shuren J, Temple R, Woodcock J, Yue LQ, Califf RM. Real-World Evidence - What Is It and What Can It Tell Us? N Engl J Med. 2016 Dec 8;375(23):2293-2297.

Custer B, Stramer SL, Glynn S, Williams AE, Anderson SA. Transfusion-transmissible infection monitoring system: a tool to monitor changes in blood safety. Transfusion. 2016 Jun;56(6 Pt 2):1499-502.

Ball R, Robb M, Anderson SA, Dal Pan G. The FDA's sentinel initiative--A comprehensive approach to medical product surveillance. Clin Pharmacol Ther. 2016 Mar;99(3):265-8.

Menis M, Forshee RA, Kumar S, McKean S, Warnock R, Izurieta HS, Gondalia R, Johnson C, Mintz PD, Walderhaug MO, Worrall CM, Kelman JA, Anderson SA. Babesiosis Occurrence among the Elderly in the United States, as Recorded in Large Medicare Databases during 2006-2013. PLoS One. 2015 Oct 15;10(10):e0140332.
Peter Twomey, MPharm, LLB

Peter Twomey, MPharm, LLB

GCP/PV Inspections Manager
Health Products Regulatory Authority (HPRA)
Ireland

Peter holds the position of GCP/PV inspection manager with the Irish health products regulator, the Health Products Regulatory Authority (HPRA). He is the Irish representative at both the GCP and PV EMA co-ordinated inspector working groups, a member of the GCP IWG CMDh working party (which focuses on bioequivalence inspections), and is a member of two expert groups tasked with proposing text for implementing acts of the new EU Veterinary Regulation. Prior to joining the HPRA, he held various positions including the position of pharmacovigilance inspector with the MHRA (the UK health products regulator), qualified person for pharmacovigilance (QPPV) and pharmacovigilance manager in industry. He holds Master of Pharmacy and Bachelor of Laws degrees (both honours).
Jean-Christophe Delumeau, MD, PhD

Jean-Christophe Delumeau, MD, PhD

Head of Pharmacovigilance Policy Strategy (Global)
Bayer South-East Asia
Singapore

Based in Asia for 20 years, Jean-Christophe graduated in Medicine and neuropharmacology from universities of Rennes (MD) and Paris-Sorbonne (PhD). After medical residency and research experience at INSEM in Paris, he moved to clinical research, based in Basel, Paris and Tokyo conducting multinational trials in neurodegenerative and cerebrovascular disorders. From 2002, he took over the pharmacovigilance department of Bayer in Japan until his appointment as head of Pharmacovigilance for Asia-Pacific and China (2009), based in Beijing until 2014, then in Singapore. In 2017, he was appointed head of Pharmacovigilance Policy Strategy. Since 2016, he is serving as Board and Executive Committee Member of the International Society of Pharmacovigilance also involved in the European Federation of Pharmaceutical Industries and Associations.

2020 KIDS-APEC PV CoE Training