Selection from HEOR Bibliography
| Search criteria | ||||
| Risk Management & REMS |
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| A cross-sectional survey to evaluate prescribers' knowledge and understanding of safety messages following Dengvaxia® product information update | ||||
| Mariana F Almas 1, Massoud Toussi 2, Elisa Valero 3, Annick Moureau 4, Lydie Marcelon | ||||
| 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. | ||||
| Pharmacoepidemiol Drug Saf . 2022 Jul;31(7):758-768. doi: 10.1002/pds.5447. Epub 2022 May 13 |
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| , Article | ||||
| , 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) | ||||
| Almas MF, Hoogendoorn WE, Sayeed S, Blackburn S, Bosco J, Parmenter L | ||||
| IQVIA | ||||
| , Poster | ||||
| 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. | ||||
| Jouaville LS, Paul T, Almas MF | ||||
| IQVIA | ||||
| Pharmacoepidemiol Drug Saf. 2021 Sep;30(9):1143-1152. doi: 10.1002/pds.5301. |
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| , Article | ||||
| , 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 | ||||
| Laurence Sophie Jouaville 1, Tulika Paul 2, Mariana Ferreira Almas | ||||
| QVIA Real World Solutions, La Defense, France. 2IQVIA Real World Solutions, Gurugram, Haryana, India. 3IQVIA Real World Solutions, Porto Salvo, Portugal. | ||||
| Pharmacoepidemiol Drug Saf . 2021 Sep;30(9):1143-1152. doi: 10.1002/pds.5301. Epub 2021 Jun 24. |
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| , Article | ||||
| 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 | ||||
| Jouaville LS, Ehrhardt C, Kürzinger ML, de Voogd H, Toussi M | ||||
| IQVIA | ||||
| Epidemiology (Sunnyvale) 9: 372. DOI: 10.4172/2161-1165.1000372 |
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| , Article | ||||
| , 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. | ||||
| Engel P, Almas MF, De Bruin ML, Starzyk K, Blackburn, Dreyer NA. | ||||
| British Journal of Clinical Pharmacology |
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| , Article | ||||
| 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. | ||||
| Toussi M1, Garofano A1, Jouaville L1, Bardoulat I1, Mitrofan L1 | ||||
| 1 QuintilesIMS, La Défense, France | ||||
| 33rd International Conference on Pharmacoepidemiology & Therapeutic Risk Management, 2017, August 26-30, Montreal, Canada |
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| , Poster | ||||
| , 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? | ||||
| Mariana F. Almas1, Pierre Engel2, Marieke L. De Bruin3, Kathryn Starzyk4, Blackburn Stella1 and Dreyer A. Nancy5 | ||||
| 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 | ||||
| , Abstract | ||||
| 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 | ||||
| Blackburn SCF. | ||||
| Risk Management in Pharmacoepidemiology, 5th edition. Edited Strom, Kimmel & Hennessy 2012 Wiley Blackwell |
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| , Book chapter | ||||
| 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 | ||||
| Zomerdijk IM, Sayed-Tabatabaei FA, Trifirò G, Blackburn SCF, Sturkenboom MCJM, Straus SMJM | ||||
| Pharmacoepidemiology and Drug Saf. 2011; 20:S228-S9 |
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| , Abstract | ||||
| 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 | ||||
| Giezen TJ, Mantel-Teeuwisse AK, Straus SMJM, Egberts TCG, Blackburn S, Persson I, et al | ||||
| Drug Safety. 2009;32(12):1175-87 |
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| , Article | ||||
| Condition | Year | Language | Analysis type | |
| , Risk Management & REMS | 2009 | English | , RWLPR (Real-World Late Phase Research-quintiles | |
| Changes in FDA’s Approach to Risk | ||||
| Gliklich RE, Bertagna Leavy M | ||||
| Applied Clinical Trials 2008; 17(10):44-50 |
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| 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 | ||||
| Dreyer NA, Blackburn S, Karwoski C, Stephenson W, Sprafka M | ||||
| Mid-Year Meeting Symposium, Boston, MA, May, 2008 |
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| , Article | ||||
| 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 | ||||
| Dreyer NA, Blackburn S, Karwoski C, Stephenson W, Sprafka M | ||||
| Mid-Year Meeting Symposium, Boston, MA, May, 2008 |
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| , Article | ||||
| 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 | ||||
| Blackburn SCF | ||||
| 1st edition. Edited Hartzema, Tilson Chan 2008 |
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| , Book chapter | ||||
| Condition | Year | Language | Analysis type | |
| , Risk Management & REMS | 2008 | English | , RWLPR (Real-World Late Phase Research-quintiles | |