Coordinator Signal Detection. MEpi Epidemiologist PhD level. Eijkhagen College (Netherlands) Scientific publications (Pubmed Indexed):

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1 Curriculum vitae PERSONAL INFORMATION Florence van Hunsel WORK EXPERIENCE September 2005 Present Coordinator Signal Detection Netherlands Pharmacovigilance Centre Lareb (Netherlands) Head of the signal detection process within the Netherlands Pharmacovigilance Centre Lareb including the (statistical) detection of signals, signal management, signal discussion meetings with the Dutch Medicines Evaluation Board and coordinating the publication process within Lareb. November 2011 Present External guest researcher at the Division of Pharmacotherapy and Pharmaceutical Care of the Department of Pharmacy of the Rijksuniversiteit Groningen (RUG) Rijksuniversiteit Groningen (Netherlands) Continuation research on patient reporting of adverse drug reactions in pharmacovigilance. Superviser of PhD project The impact of direct patient reporting in pharmacovigilance of L. Rolfes at the Division of Pharmacotherapy and Pharmaceutical Care of the Department of Pharmacy of the Rijksuniversiteit Groningen (RUG). Guest lecturer on pharmacovigilance topic. EDUCATION AND TRAINING March 2008 November 2011 External PhD student Rijksuniversiteit Groningen (Netherlands) PhD topic: The contribution of direct patient reporting to pharmacovigilance Promotores: Prof. Dr. A.C. van Grootheest, Division of Pharmacotherapy and Pharmaceutical Care (RUG), The Netherlands & Prof. Dr. L.T.W. de Jong-van den Berg, Division of Pharmacoepidemiology and Pharmacoeconomics (RUG), The Netherlands January 2009 May 2015 MEpi Epidemiologist PhD level Vrije Universiteit (VU) (Netherlands) Broad epidemiology education at the EMGO Institute of the Vrije Universiteit, Amsterdam September 1999 August 2005 PharmD Universiteit Utrecht (Netherlands) Pharmaceutical Sciences - Registered as a pharmacist Internships during M.Sc. education: Division of Psychopharmacology, Department of Psychonomics, University of Utrecht, the Netherlands. Research: Acute effects of nicotine on attention and response inhibition. September 1993 August 1999 Senior High School Eijkhagen College (Netherlands) ADDITIONAL INFORMATION Expertise (statistical) signal detection, patient reporting in pharmacovigilance and pharmacovigilance of herbal medicines Publications Scientific publications (Pubmed Indexed): 18/12/15 European Union, Page1 / 5

2 van Hunsel F, van de Koppel S, van Puijenbroek,E. Post-Menopausal Vaginal Hemorrhage Related to the Use of a Hop-Containing Phytotherapeutic Product. Drug Saf Case Reports 2015;2:14 Matos C, van Hunsel F, Joaquim J. Are consumers ready to take part in the Pharmacovigilance System?-a Portuguese preliminary study concerning ADR reporting. Eur J Clin Pharmacol. 2015;71(7): Rolfes L, van Hunsel F, van Grootheest K, van Puijenbroek E. Feedback for patients reporting adverse drug reactions; satisfaction and expectations. Expert Opin Drug Saf. 2015;14(5): Härmark L, van Hunsel F, Grundmark B. ADR Reporting by the General Public: Lessons Learnt from the Dutch and Swedish Systems. Drug Saf. 2015;38(4): Rolfes L, van Hunsel F, Wilkes S, van Grootheest K, van Puijenbroek E. Adverse drug reaction reports of patients and healthcare professionals-differences in reported information. Pharmacoepidemiol Drug Saf. 2015;24(2): Rolfes L, de Swart-Ruijter I, van Hunsel F. Labetalol for hypertension during pregnancy and nipple pain. Eur J Obstet Gynecol Reprod Biol. 2014;182(11): de Vries L, van Hunsel F, Cuppers-Maarschalkerweerd B, van Puijenbroek E, van Grootheest K. Adjuvanted A/H1N1 (2009) influenza vaccination during pregnancy: Description of a prospective cohort and spontaneously reported pregnancy-related adverse reactions in the Netherlands. Birth Defects Res A Clin Mol Teratol. 2014;100(10):731-8 Kant A, van Puijenbroek E, van Hunsel F. Reflections after the Diane affair. J Thromb Haemost. 2014;12(9): van Hunsel FP, Kant AC, van Puijenbroek EP. Thrombosis and embolism during Diane-35 use: analysis of reports made to the Netherlands Pharmacovigilance Centre Lareb. Ned Tijdschr Geneeskd. 2014;158:A6651. Rolfes L, Wilkes S, van Hunsel F, van Puijenbroek E, van Grootheest K. Important information regarding reporting of adverse drug reactions: a qualitative study. Int J Pharm Pract Jun;22(3): van Hunsel FPAM, van Grootheest AC. Bijwerkingen van kruidenpreparaten. Ned Tijdschr Geneeskd. 2013;157:A6615. van Hunsel FPAM, Kampschoër PHNM. Postmenopauzaal bloedverlies en voedingssupplementen. Ned Tijdschr Geneeskd. 2012;156:A5095. Oosterhuis I, van Hunsel FP, van Puijenbroek EP. Expectations for Feedback in Adverse Drug Reporting by Healthcare Professionals in the Netherlands. Drug Saf. 2012;35 (3): van Hunsel F, Härmark L, Pal S, Olsson S, van Grootheest K. Experiences with adverse drug reaction reporting by patients: an 11-country survey. Drug Saf. 2012;35(1): van Hunsel F, van Grootheest K. Adverse drug reactions of a slimming product contaminated with sibutramine. Ned Tijdschr Geneeskd. 2011;155(42):A3695. Härmark L, van Hunsel F, Hak E, van Grootheest K. Monitoring the safety of influenza A (H1N1) vaccine using web-based intensive monitoring. Vaccine 2011;29(10): van Hunsel F, Talsma A, van Puijenbroek E, de Jong-van den Berg L, van Grootheest K. The proportion of patient reports of suspected ADRs to signal detection in the Netherlands: case-control study. Pharmacoepidemiol Drug Saf 2011;20(3): van Hunsel F, van der Welle C, Passier A, van Puijenbroek E, van Grootheest K. Motives for reporting adverse drug reactions by patient-reporters in the Netherlands. Eur J Clin Pharmacol 2010;66: van Hunsel FP, ten Berge EA, Borgsteede SD, van Grootheest K. What Motivates Patients to Report an Adverse Drug Reaction? Ann Pharmacother 2010;44(5): van Hunsel F, van Puijenbroek E, de Jong- van den Berg L, van Grootheest K. Media attention and the influence on the reporting odds ratio in disproportionality analysis: an example of patient reporting of statins. Pharmacoepidemiol Drug Saf 2010; 19(1): van Hunsel F, Passier A, van Grootheest AC. Comparing patients' and healthcare professionals' ADR reports after media attention: the broadcast of a Dutch television programme about the benefits and risks of statins as an example. Br J Clin Pharmacol 2009; 67(5): Van de Meerendonk HWPC, van Hunsel FPAM, van der Wiel HE. Autoimmune hepatitis induced by Actaea racemosa. Side effects of an herb extract. Ned Tijdschr Geneeskd 2009;53(6): de Langen J, van Hunsel F, Passier A, de Jong-van den Berg L, van Grootheest K. Adverse Drug Reaction Reporting by Patients in the Netherlands Three Years of Experience. Drug Saf 18/12/15 European Union, Page2 / 5

3 2008;31(6): Bekker EM, Böcker KB, Van Hunsel F, van den Berg MC, Kenemans JL. Acute effects of nicotine on attention and response inhibition. Pharmacol Biochem Behav 2005;82(3): Bekker EM, van Hunsel F, Kenemans JL. Acute effects of nicotine on attention and response inhibition. Chapter in Thesis Inhibitory Control and Adults with ADHD (Department of Psychopharmacology, Department of Psychonomics, Utrecht University, The Netherlands). Professional publications: de Jong L, van Hunsel F. Terbinafine oraal kan smaak en reuk verstoren. Pharm Weekbld 2015;150(25): Rolfes L, van Hunsel F. Check regelmatig metabole waarden bij antipsychotica. Pharm Weekbld 2015;150(17): Smeets T, van Hunsel F. Huidverkleuring: nieuwe bijwerking doxycycline. Pharm Weekbld 2015;150(14): Zweers P, van Hunsel F. Ook bij lage dosis nsaid s ernstige reacties mogelijk. Pharm Weekbld 2014;149(42): van Hunsel F. Methylfenidaat en trismus. Geneesmiddelenbulletin 2014;48(8):91. Zweers P, van Hunsel F. Alertheid moet gebitsschade door geneesmiddel voorkomen. Pharm Weekbld 2014;149(30/31): van Hunsel F, van de Koppel S, Kant A. Alertheid vereist bij hoog gedoseerde vitaminepillen. Pharm Weekbld 2014;149(10): van Hunsel F, Zweers P. Gelijktijdig gebruik van tranylcypromine en trazodon kan leiden tot het serotoninesyndroom. Pharm Weekbld - Wetenschappelijk Platform 2013;7(7/8): Jessurun NT, van Hunsel, F. Bijwerkingen bij kinderen. Praktische Pediatrie 2013(7);2: van Hunsel F, Härmark L. Onder stroom door duloxetine. Pharm Weekbld 2013;148(23): Jessurun N, van Hunsel F. Leverschade niet te onderschatten bijeffect. Pharm Weekbld 2013;148(5): Rolfes L, van der Horst P, van Hunsel F. Veel klachten van patiënten na substitutie. Pharm Weekbld 2012;147(41): van Hunsel F, van der Welle C, Passier A, van Puijenbroek E, van Grootheest K. Motieven voor het melden van bijwerkingen door patiënten in Nederland. Pharm Weekbld - Wetenschappelijk Platform 2012;6(10): van Hunsel F, Dijkers FW. Benauwdheid als bijwerking van geneesmiddelengebruik. Bijblijven 2012;28(5): van den Tweel AMA, van Hunsel FPAM, Derijks HJ, Hermens WAJJ, van Puijenbroek EP, van Grootheest AC. Onderzoek naar het effect van een digitale meldmodule op het aantal gemelde bijwerkingen in een algemeen ziekenhuis. Pharm Weekbld - Wetenschappelijk Platform 2012;6(3):a1213. van Hunsel F. Altruïsme drijft patiënt bij meldingen Lareb. Pharm Weekbld 2012;147(10): van Hunsel F, van den Koppel S. Populaire afslankmiddelen soms best link. Pharm Weekbld 2012;147(9): van Hunsel F. Lithium en downbeat -nystagmus. Geneesmiddelenbulletin 2011;45(6): van Grootheest K, van Hunsel F. Meldingen helpen bijwerkingen ontrafelen. Pharm Weekbld 2010;145(9): Passier JLM, van Hunsel FPAM, van Puijenbroek EP. (Des)loratadine en convulsies. Tijdschr Neurol Neurochir 2009;110: van Hunsel F. Opeens een bos krullen; Bijwerking van valproïnezuur soms welkom. Pharm Weekbld 2009;144(36): van Hunsel FPAM, de Smet PAGM, van Klei N, van Grootheest AC. Indonesische kruidenthee bevat ongewenste Westerse geneesmiddelen. Pharm Weekbld - Wetenschappelijk Platform 2008;2(7): van Hunsel F, van Grootheest K. Keerzijde van kruiden. Pharm Weekbld 2007;142(49): van Hunsel F, van Puijenbroek E. Domperidon en Extrapiramidale stoornissen; Risico bij Kinderen. Pharm Weekbld 2007;142(39): van Hunsel F, Bijl A. De gevaarlijke cocktail van UV en pil; Kans op zowel fototoxische als 18/12/15 European Union, Page3 / 5

4 fotoallergische reactie. Pharm Weekbld 2007;142(27): van Hunsel F. Farmacovigilantie bij fytotherapeutica. Nederlands Tijdschrift voor Fytotherapie 2007;20(2): van Hunsel FPAM, van Grootheest AC. ACE-remmers en hallucinaties. Geneesmiddelenbulletin 2006;40(12): van Hunsel F, van Grootheest K. Hypertensie als bijwerking van geneesmiddelen. Pharm Weekbld 2005;140(48): Abstracts: Rolfes L, van Hunsel F, van Puijenbroek E. A Dutch study on the impact of ADRs after packaging changes of the drug Thyrax on patient s quality of life. Accepted for ISoP 2015 Scholl J, van Hunsel F, Harmark L. Case-by-case assessment of ICSRs from Marketing Authorization Holders: a pilot study. Accepted for ISoP 2015 van Hunsel F, Ekhart C. Experiences With a Computer-Assisted Database Screening Tool at the Netherlands Pharmacovigilance Centre Lareb. Accepted for ICPE Jessurun N, van Hunsel F, van Puijenbroek E. Metabolic acidosis with a high anion: a drug-drug interaction between paracetamol and flucloxacillin. Clinical Therapeutics 2015;37(8):e47. Matos C, van Hunsel FPAM, Joaquim JJ. Are patients ready to take part in the pharmacovigilance system? A Portuguese preliminary study concerning ADR reporting. Clinical Therapeutics 2015;37(8):e5. Matos C, van Hunsel F, Joaquim J. Are Patients ready to Take Part in the Pharmacovigilance System?; A Portuguese Preliminary Study concerning Drug Reaction Reporting. Pharmacoepidem Drug Saf 2014; 23(S1):293 van Hunsel F, van Puijenbroek E. Spontaneous Reports of Thromboembolic Events Associated with Cyproterone/ Ethinylestradiol after media attention. Pharmacoepidem Drug Saf 2014; 23(S1): Rolfes L, Kolfschoten J, van Hunsel F, van Puijenbroek E, van Grootheest K. Validation of Signal Impact Assessment Tool in order to explore pharmacovigilance signals follow-up actions. Pharmacoepidem Drug Saf 2014; 23(S1): van Hunsel F, van Puijenbroek E. Analysis of Spontaneous Reports of Thromboembolic Adverse Drug Reactions Associated with Cyproterone/Ethinylestradiol. Drug Saf 2013;36(9):817 Rolfes L, van Hunsel, F, van Puijenbroek E, van Grootheest K. Adverse drug reaction reports of patients and healthcare professionals; how different are they? Pharmacoepidem Drug Saf 2013;22:S1 S632 Morelli FM, Posthuma EFM, van Hunsel FPAM. Hypercapnic coma after ingestion of an antitussive agent in a 69-year-old man affected by chronic obstructive pulmonary disease. Internistendagen abstractbook 2013;(25):135. Härmark L, van Hunsel F, Hak E, van Grootheest AC. Monitoring the Safety of the Influenza A H1N1 Vaccine: An Observational Cohort Study. Drug Saf 2010;33(10) van Hunsel F, van Puijenbroek E, van Grootheest K. The Contribution of Patient Reporting To Signal Detection in the Netherlands. Pharmacoepidem Drug Saf 2010;19:S1 S347. van der Meerdendonk HWPC, van Hunsel FPAM, van der Wiel HE. Black Cohosh (cimicifuga racemosa) induced autoimmune hepatitis. Internistendagen abstractbook 2008;(20):40. van Hunsel F, van Grootheest AC. The use of complementary medicines and the reporting of their ADRs in the Netherlands. FIP (International Pharmaceutical Federation) abstract book, 2007 Projects Researcher and lecturer for the Monitoring Medicines project, key partners in the project: World Health Organization (WHO) and the Uppsala Monitoring Centre of the WHO ( Research activities for WEB-RADR project on contribution to signal detection of reports received through the WEB-RADR app (project started in 2014) Supervisor PhD project Patient reporting in pharmacovigilance of Cristiano Matos at University of Seville, Spain, 2014-current. Memberships Practice Committee of the Dutch Medicines Evaluation Board (MEB) Member editorial board Drug Safety-Case Reports 18/12/15 European Union, Page4 / 5

5 Other Relevant Information Key Presentations: Examples of the role of patient reports in safety signals, Lareb conference on patient reporting current perspectives and future possibilities, April Leiden, the Netherlands Consumer Reporting: The Dutch and International Experiences, Pharmacy Master Symposium 2014, Coimbra Health School, Portugal, June 2014 Consumer Reporting: The Dutch and International Experiences, International Training Course in Pharmacovigilance, Uppsala, Sweden, May 2014 and 2015 Consumer Reporting: The Dutch and international Experiences, 7. Deutscher Pharmacovigilanz- Tag, Bonn, Germany, November 2012 Empowering patients in pharmacovigilance: first results from an interregional consortium, Technical briefing at the 65th World Health Assembly in Geneva, Switzerland, May "The Contribution of Patient Reporting To Signal Detection in the Netherlands, ICPE conference, Brighton, UK, Augustus Results from an international survey on consumer reporting of ADRs, Survey Review Panel meeting organized by Monitoring Medicines FP7 Project, Uppsala Monitoring Centre, Uppsala, Sweden, December Courses: SQL Basis, Learnit Trainingen, 2014 Using R in Data Analysis, Boerhaave, 2012 Herbal drugs in Pharmacy and as Food supplements, PAO Farmacie, 2012 Qualitative Research Methods in Health Care, CaRe (Netherlands School of Primary Care Research), University of Nijmegen, 2008 Summercourse Pharmaceutical Policy Analysis, University of Utrecht, 2008 SPSS for PhD students, University of Groningen, 2008 Summercourse Epidemiology & Drug Safety, University of Utrecht, /12/15 European Union, Page5 / 5