Selection from HEOR Bibliography

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Condition: Risk Management & REMS
 
A cross-sectional survey to evaluate prescribers' knowledge and understanding of safety messages following Dengvaxia® product information update
Authors: Mariana F Almas 1, Massoud Toussi 2, Elisa Valero 3, Annick Moureau 4, Lydie Marcelon
Affiliations: 1IQVIA Real World Solutions, Porto Salvo, Portugal. 2IQVIA Real World &Analytics Solutions, La Défense, France. 3Global Pharmacovigilance, Sanofi Pasteur, Lyon, France. 4Global Biostatistical Sciences, Sanofi Pasteur, Marcy l'Etoile, France. 5Epidemiology and Benefit Risk, Global Pharmacovigilance, Sanofi Pasteur, Lyon, France.
Publications: 
Pharmacoepidemiol Drug Saf . 2022 Jul;31(7):758-768. doi: 10.1002/pds.5447. Epub 2022 May 13
Document Types: , Article
Countries: , Brazil, Thailand
Abstract: https://pubmed.ncbi.nlm.nih.gov/35505623/
Condition Year Language Analysis type
, Immunology and Vaccination, Risk Management & REMS 2022 English , Clinical setting: Primary care, Epidemiological study, Survey research
 
 
Insights from a review of publicly available information on Post Authorisation Safety Studies (PASS)
Authors: Almas MF, Hoogendoorn WE, Sayeed S, Blackburn S, Bosco J, Parmenter L
Affiliations: IQVIA
Publications: 
Document Types: , Poster
Countries: 
Condition Year Language Analysis type
, Drug safety, Risk Management & REMS 2022 English , Review
 
 
A review of the sampling methodology used in studies evaluating the effectiveness of risk minimisation measures in Europe.
Authors: Jouaville LS, Paul T, Almas MF
Affiliations: IQVIA
Publications: 
Pharmacoepidemiol Drug Saf. 2021 Sep;30(9):1143-1152. doi: 10.1002/pds.5301.
Document Types: , Article
Countries: , Europe
Abstract: https://onlinelibrary.wiley.com/doi/full/10.1002/pds.5301
Condition Year Language Analysis type
, Guidelines, Methodology, Risk Management & REMS 2021 English , Literature Review
 
 
A review of the sampling methodology used in studies evaluating the effectiveness of risk minimisation measures in Europe
Authors: Laurence Sophie Jouaville 1, Tulika Paul 2, Mariana Ferreira Almas
Affiliations: QVIA Real World Solutions, La Defense, France. 2IQVIA Real World Solutions, Gurugram, Haryana, India. 3IQVIA Real World Solutions, Porto Salvo, Portugal.
Publications: 
Pharmacoepidemiol Drug Saf . 2021 Sep;30(9):1143-1152. doi: 10.1002/pds.5301. Epub 2021 Jun 24.
Document Types: , Article
Countries: 
Abstract: https://pubmed.ncbi.nlm.nih.gov/34092001/
Condition Year Language Analysis type
, Methodology, Risk Management & REMS 2021 English , Database Study
 
 
Evaluation of the Effectiveness of Risk Minimisation Measures Targeting Physicians on Prescribing Practices of Thiocolchicoside Containing Medicinal Products for Systemic Use
Authors: Jouaville LS, Ehrhardt C, Kürzinger ML, de Voogd H, Toussi M
Affiliations: IQVIA
Publications: 
Epidemiology (Sunnyvale) 9: 372. DOI: 10.4172/2161-1165.1000372
Document Types: , Article
Countries: , France, Greece, Italy, Portugal
Abstract: https://www.omicsonline.org/open-access/evaluation-of-the-effectiveness-of-risk-minimisation-measures-targeting-physicians-on-prescribing-practices-of-thiocolchicoside-co-2161-1165-1000372-108159.html
Condition Year Language Analysis type
, Musculoskeletal disease, Rheumatology, Risk Management & REMS 2019 English , Survey research
 
 
. Lessons learned on the design and the conduct of Post-Auhorization Safety Studies: Review of 3 years of Pharmacovigilance Risk Assessment Committee (PRAC) oversight.
Authors: Engel P, Almas MF, De Bruin ML, Starzyk K, Blackburn, Dreyer NA.
Affiliations: 
Publications: 
British Journal of Clinical Pharmacology
Document Types: , Article
Countries: 
Condition Year Language Analysis type
, Risk Management & REMS 2017 English
 
 
Evaluation of the effectiveness of risk minimisation measures: a survey among health care professionals to assess their knowledge and attitudes on prescribing conditions of Instanyl® in France and the Netherlands.
Authors: Toussi M1, Garofano A1, Jouaville L1, Bardoulat I1, Mitrofan L1
Affiliations: 1 QuintilesIMS, La Défense, France
Publications: 
33rd International Conference on Pharmacoepidemiology & Therapeutic Risk Management, 2017, August 26-30, Montreal, Canada
Document Types: , Poster
Countries: , France, Netherlands
Condition Year Language Analysis type
, Drug safety, Pain, Risk Management & REMS 2017 English , Clinical setting: hospital, Clinical setting: Primary care, clinical setting: Secondary care, Public Health, Survey research
 
 
Between Risk Management and Pharmacoepidemiology: Where Do Post-Authorisation Safety Studies Stand Today?
Authors: Mariana F. Almas1, Pierre Engel2, Marieke L. De Bruin3, Kathryn Starzyk4, Blackburn Stella1 and Dreyer A. Nancy5
Affiliations: 1Real-World & Late Phase Research, Reading, Berkshirek, United Kingdom; 2Real-World & Late Phase Research, France; 3Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht, Netherlands; 4Real-World & Late Phase Research, Cambridge, United States; 5University of North Carolina, Chapel Hill, United States
Publications: 
Document Types: , Abstract
Countries: 
Abstract: https://onlinelibrary.wiley.com/doi/full/10.1002/pds.4070
Condition Year Language Analysis type
, Drug safety, Regulatory, Risk Management & REMS 2016 English , Review
 
 
Risk Management in Pharmacoepidemiology
Authors: Blackburn SCF.
Affiliations: 
Publications: 
Risk Management in Pharmacoepidemiology, 5th edition. Edited Strom, Kimmel & Hennessy 2012 Wiley Blackwell
Document Types: , Book chapter
Countries: 
Condition Year Language Analysis type
, Risk Management & REMS 2012 English , RWLPR (Real-World Late Phase Research-quintiles
 
 
Risk minimisation activities of centrally authorised products in the european union: A descriptive study
Authors: Zomerdijk IM, Sayed-Tabatabaei FA, Trifirò G, Blackburn SCF, Sturkenboom MCJM, Straus SMJM
Affiliations: 
Publications: 
Pharmacoepidemiology and Drug Saf. 2011; 20:S228-S9
Document Types: , Abstract
Countries: 
Condition Year Language Analysis type
, Risk Management & REMS 2011 English , RWLPR (Real-World Late Phase Research-quintiles
 
 
Evaluation of post-authorization safety studies in the first cohort of eu risk management plans at time of regulatory approval
Authors: Giezen TJ, Mantel-Teeuwisse AK, Straus SMJM, Egberts TCG, Blackburn S, Persson I, et al
Affiliations: 
Publications: 
Drug Safety. 2009;32(12):1175-87
Document Types: , Article
Countries: 
Condition Year Language Analysis type
, Risk Management & REMS 2009 English , RWLPR (Real-World Late Phase Research-quintiles
 
 
Changes in FDA’s Approach to Risk
Authors: Gliklich RE, Bertagna Leavy M
Affiliations: 
Publications: 
Applied Clinical Trials 2008; 17(10):44-50
Document Types: 
Countries: 
Condition Year Language Analysis type
, Risk Management & REMS 2008 English , RWLPR (Real-World Late Phase Research-quintiles
 
 
How will FDAAA change our approach to REMS? International Society of Pharmacoepidemiology
Authors: Dreyer NA, Blackburn S, Karwoski C, Stephenson W, Sprafka M
Affiliations: 
Publications: 
Mid-Year Meeting Symposium, Boston, MA, May, 2008
Document Types: , Article
Countries: 
Condition Year Language Analysis type
, Risk Management & REMS 2008 English , RWLPR (Real-World Late Phase Research-quintiles
 
 
How will FDAAA change our approach to REMS? International Society of Pharmacoepidemiology
Authors: Dreyer NA, Blackburn S, Karwoski C, Stephenson W, Sprafka M
Affiliations: 
Publications: 
Mid-Year Meeting Symposium, Boston, MA, May, 2008
Document Types: , Article
Countries: 
Condition Year Language Analysis type
, Risk Management & REMS 2008 English , RWLPR (Real-World Late Phase Research-quintiles
 
 
Risk Management in the European Union in Pharmacoepidemiology and Therapeutic Risk Management
Authors: Blackburn SCF
Affiliations: 
Publications: 
1st edition. Edited Hartzema, Tilson Chan 2008
Document Types: , Book chapter
Countries: 
Condition Year Language Analysis type
, Risk Management & REMS 2008 English , RWLPR (Real-World Late Phase Research-quintiles
 
 
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