Sabine Straus
European Medicines Agency
Risk analysis (engineering)PsychiatryImplementation theoryRisk management planRisk assessmentAgency (sociology)Product (category theory)BusinessHealth careContent analysisIntensive care medicinePediatricsProcess managementAsset (economics)StakeholderYoung adultBalance (accounting)EpilepsyMigraineDiseasePregnancyPatient safetyMEDLINEToxic epidermal necrolysisDrug UtilizationSafety CommunicationsEpidermal necrosisMigraine prophylaxisEuropean unionPatient care teamPublic awarenessPatient careDrug approval2019-20 coronavirus outbreakSevere acute respiratory syndrome coronavirus 2 (SARS-CoV-2)Coronavirus disease 2019 (COVID-19)Active participationChildbearing ageTarget populationFemale patientPrevention controlHealth professionalsPharmacology toxicologyPublic administrationRisk managementPublic relationsGlobal healthPharmacovigilanceMedicineMinimisation (clinical trials)
6Publications
3H-index
21Citations
Publications 7
Newest
#1Priya Bahri (European Medicines Agency)H-Index: 12
#2Daniel R. Morales (European Medicines Agency)H-Index: 21
Last. Sabine Straus (European Medicines Agency)H-Index: 3
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#1Dianne Butler (European Medicines Agency)
#2Katarina Vucic (European Medicines Agency)H-Index: 1
Last. John-Joseph Borg (European Medicines Agency)H-Index: 3
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Introduction: Risk Management Plans (RMPs) aim to optimize a medicinal product's benefit/risk balance both for the individual patient and the target population. Despite differences in regulatory RMP requirements between jurisdictions worldwide, their ultimate aim is to protect public health.Areas Covered: The review presents findings of the different RMP requirements by different regulatory authorities and additional risk minimisation measures (issued between January 2010 and December 2018) indi...
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#1Priya Bahri (European Medicines Agency)H-Index: 12
#2Daniel R. Morales (Dund.: University of Dundee)H-Index: 21
Last. Sabine Straus (European Medicines Agency)H-Index: 3
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Understanding the impact of regulatory actions for medicines and enablers/barriers for positive health outcomes is fundamental to effective risk minimisation measures (RMM). Therefore, the Impact Strategy of the European Union (EU) Pharmacovigilance Risk Assessment Committee (PRAC) includes engagement with patient communities and healthcare professional (HCP) bodies regarding RMM. However, there is uncertainty on how best to obtain stakeholder input. The objectives of this study were to (1) anal...
3 CitationsSource
#1Marco Cavaleri (European Medicines Agency)H-Index: 15
#2Harald Enzmann (Federal Institute for Drugs and Medical Devices)H-Index: 12
Last. Emer Cooke (European Medicines Agency)H-Index: 1
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24 CitationsSource
#1Wan-Chun Chang (UBC: University of British Columbia)H-Index: 10
Abstract Stevens-Johnson syndrome and toxic epidermal necrolysis (SJS/TEN) are potentially life-threatening, immune-mediated adverse reactions characterized by widespread erythema, epidermal necrosis, and detachment of skin and mucosa. Efforts to grow and develop functional international collaborations and a multidisciplinary interactive network focusing on SJS/TEN as an uncommon but high burden disease will be necessary to improve efforts in prevention, early diagnosis and improved acute and lo...
12 CitationsSource
#1Efstratia Vatzaki (European Medicines Agency)H-Index: 1
#2Sabine Straus (European Medicines Agency)H-Index: 3
Last. Paolo MartellettiH-Index: 47
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Migraine is a common and burdensome neurological condition which affects mainly female patients during their childbearing years. Valproate has been widely used for the prophylaxis of migraine attacks and is also included in the main European Guidelines. Previous (2014) European recommendations on limiting the use of valproate in women of childbearing age did not achieve their objective in terms of limiting the use of valproate in women of childbearing age and raising awareness regarding the haza...
8 CitationsSource
#1Reetta Kälviäinen (University of Eastern Finland)H-Index: 66
#2Sabine StrausH-Index: 3
Last. Manuel Haas (European Medicines Agency)H-Index: 8
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Close Researchers
Jean-Michel Dogné
H-index : 52
Université de Namur
Daniel R. Morales
H-index : 21
University of Dundee
Ricardo Cibotti
H-index : 8
National Institutes of Health
Shuen-Iu Hung
H-index : 4
Memorial Hospital of South Bend
Elyse A. Hope
H-index : 1
Sonia Whyte-Croasdaile
H-index : 1
Hongsheng Wang
H-index : 1
Chinese Center for Disease Control and Prevention
Nicole Chapman
H-index : 1
Katarina Vucic
H-index : 1
European Medicines Agency
Efstratia Vatzaki
H-index : 1
European Medicines Agency
Jessica Weintraub
H-index : 2
Center for Drug Evaluation and Research
Serge Bakchine
H-index : 5
Cristina Olteanu
H-index : 5
University of Alberta
Mahyar Etminan
H-index : 42
University of British Columbia
Esther Fuchs
H-index : 2
University of Washington
Gianpiero L. Cavalleri
H-index : 43
Royal College of Surgeons in Ireland
Sonia N. Yeung
H-index : 13
University of British Columbia
Thomas M. Beachkofsky
H-index : 8
Uniformed Services University of the Health Sciences
Alfonso Iovieno
H-index : 16
University of British Columbia
Agnieszka K. Biala
H-index : 4
University of British Columbia
Simona Volpi
H-index : 16
National Institutes of Health
Lisa M. Wheatley
H-index : 14
National Institutes of Health
Li Zhou
H-index : 22
Brigham and Women's Hospital
Juan Garcia Burgos
H-index : 4
European Medicines Agency
Kristina B. Williams
H-index : 4
Vanderbilt University Medical Center
Christine Shieh
H-index : 8
Vanderbilt University
Michael A. Norcross
H-index : 23
Food and Drug Administration
Benjamin Micallef
H-index : 2
European Medicines Agency
Anthony Serracino-Inglott
H-index : 6
University of Malta
Munir Pirmohamed
H-index : 114
University of Liverpool
Ulrike Dehaeck
H-index : 3
University of British Columbia
Harald Enzmann
H-index : 12
Federal Institute for Drugs and Medical Devices
Sherrie J. Divito
H-index : 17
Brigham and Women's Hospital
Cynthia Sung
H-index : 33
National University of Singapore
Hajirah N. Saeed
H-index : 12
Massachusetts Eye and Ear Infirmary
James H. Holmes
H-index : 32
University of Wisconsin-Madison
Marco Cavaleri
H-index : 15
European Medicines Agency
Bruce Carleton
H-index : 39
University of British Columbia
Galen E.B. Wright
H-index : 19
University of Manitoba
Mee Kum Kim
H-index : 30
New Generation University College
Emer Cooke
H-index : 1
European Medicines Agency
John-Joseph Borg
H-index : 3
University of Rome Tor Vergata
Neil H. Shear
H-index : 77
Sunnybrook Health Sciences Centre
Teresa Bellón
H-index : 29
Hospital Universitario La Paz
Jonathan C. Peter
H-index : 30
University of Cape Town
Chonlaphat Sukasem
H-index : 22
Mahidol University
Hyon K. Choi
H-index : 111
Harvard University
Mario E. Lacouture
H-index : 75
Memorial Sloan Kettering Cancer Center
Manuel Haas
H-index : 8
European Medicines Agency
Charles S. Bouchard
H-index : 18
Loyola University Chicago
Riichiro Abe
H-index : 42
Niigata University
Robyn Lim
H-index : 7
Health Canada
Wen-Hung Chung
H-index : 53
Chang Gung University
Mayumi Ueta
H-index : 33
Kyoto Prefectural University of Medicine
Jennifer L. Goldman
H-index : 14
University of Missouri–Kansas City
Elizabeth J. Phillips
H-index : 61
Vanderbilt University Medical Center
Rannakoe J. Lehloenya
H-index : 16
University of Cape Town
Priya Bahri
H-index : 12
European Medicines Agency
Michael R. Ardern-Jones
H-index : 23
Southampton General Hospital
James Chodosh
H-index : 58
Massachusetts Eye and Ear Infirmary
Jason A Trubiano
H-index : 25
Peter MacCallum Cancer Centre
Reetta Kälviäinen
H-index : 66
University of Eastern Finland
Michael J. Rieder
H-index : 39
University of Western Ontario
Helena B. Pasieka
H-index : 3
MedStar Washington Hospital Center
Robert G. Micheletti
H-index : 22
University of Pennsylvania
Paolo Martelletti
H-index : 47
Sapienza University of Rome
Chia Ling Hsieh
H-index : 1
Chen Wan
H-index : 1
Julie McCawley
H-index : 1
Paul Anderson
H-index : 1
Cindy Whale
H-index : 1
Jean McCawley
H-index : 1
Wanpen Anderson
H-index : 1
Thomas Girard
H-index : 1
European Medicines Agency
Maja Mockenhaupt
H-index : 51
University of Freiburg
Amelia Cupelli
European Medicines Agency
Dianne Butler
European Medicines Agency
Wan Chun Chang
H-index : 1
University of British Columbia
Adrien Inoubli
European Medicines Agency
Angie Lowe
H-index : 1
Julienne Jagdeo
H-index : 1
Karen Dewar
H-index : 1
Genome Canada
Douglas Oboh
H-index : 1
Sheng Ying Tsou
H-index : 1
Sophie Le Pallec
H-index : 1
Zhao Qing Wang
H-index : 1
Katie Niemeyer
H-index : 1
University of Texas at Austin
Diane Forbes
H-index : 1
Canadian Institutes of Health Research
David M. Koelle
H-index : 70
University of Washington
Cynthia Sung
H-index : 3
Health Sciences Authority