Pharmacovigilance 2030: Invited Commentary for the January 2020 “Futures” Edition of Clinical Pharmacology and Therapeutics

Autor Arlett, Peter, Straus, Sabine, Rasi, Guido
Vydáno v Clin Pharmacol Ther (2019)

The European Medicines Agency's EU conditional marketing authorisations for COVID-19 vaccines

Autor Cavaleri, Marco, Enzmann, Harald, Straus, Sabine, Cooke, Emer
Vydáno v Lancet (2021)

Improving the Safety of Medicines in the European Union: From Signals to Action

Autor Potts, Joanne, Genov, Georgy, Segec, Andrej, Raine, June, Straus, Sabine, Arlett, Peter
Vydáno v Clin Pharmacol Ther (2019)

Navigating stormy waters: 10 years of operation of the European Union Regulatory Network Incident Management Plan for Medicines for Human Use

Autor Santoro, Aniello, Caplanusi, Irina, Sweeney, Fergus, Cappelli, Benedicte, Nolan, Lorraine, Straus, Sabine, Arlett, Peter
Vydáno v Pharmacoepidemiol Drug Saf (2020)

Proposals for Engaging Patients and Healthcare Professionals in Risk Minimisation from an Analysis of Stakeholder Input to the EU Valproate Assessment Using the Novel Analysing Sta...

Autor Bahri, Priya, Morales, Daniel R., Inoubli, Adrien, Dogné, Jean-Michel, Straus, Sabine M. J. M.
Vydáno v Drug Saf (2020)

Study Design and Evaluation of Risk Minimization Measures: A Review of Studies Submitted to the European Medicines Agency for Cardiovascular, Endocrinology, and Metabolic Drugs

Autor Mazzaglia, Giampiero, Straus, Sabine M. J., Arlett, Peter, da Silva, Daniela, Janssen, Heidi, Raine, June, Alteri, Enrica
Vydáno v Drug Saf (2017)

Use of Dipeptidyl Peptidase-4 Inhibitors and the Reporting of Infections: A Disproportionality Analysis in the World Health Organization VigiBase

Autor Willemen, Marjolein J., Mantel-Teeuwisse, Aukje K., Straus, Sabine M., Meyboom, Ron H., Egberts, Toine C., Leufkens, Hubert G.
Vydáno 2011

Description of the Risk Management of Medication Errors for Centrally Authorised Products in the European Union

Autor Hoeve, Christina E., Francisca, Reynold D. C., Zomerdijk, Inge, Sturkenboom, Miriam C. J. M., Straus, Sabine M. J. M.
Vydáno v Drug Saf (2019)

Dissemination of Direct Healthcare Professional Communications on Medication Errors for Medicinal Products in the EU: An Explorative Study on Relevant Factors

Autor Hoeve, Christina E., de Vries, Esther, Mol, Peter G. M., Sturkenboom, Miriam C. J. M., Straus, Sabine M. J. M.
Vydáno v Drug Saf (2020)

Number of Patients Studied Prior to Approval of New Medicines: A Database Analysis

Autor Duijnhoven, Ruben G., Straus, Sabine M. J. M., Raine, June M., de Boer, Anthonius, Hoes, Arno W., De Bruin, Marie L.
Vydáno 2013

Baseline incidence of intussusception in early childhood before rotavirus vaccine introduction, the Netherlands, January 2008 to December 2012

Autor Gadroen, Kartini, Kemmeren, Jeanet M, Bruijning-Verhagen, Patricia CJ, Straus, Sabine MJM, Weibel, Daniel, de Melker, Hester E, Sturkenboom, Miriam CJM
Vydáno v Euro Surveill (2017)

Additional safety risk to exceptionally approved drugs in Europe?

Autor Arnardottir, Arna H, Haaijer-Ruskamp, Flora M, Straus, Sabine M J, Eichler, Hans-Georg, de Graeff, Pieter A, Mol, Peter G M
Vydáno 2011

Introduction or Discontinuation of Additional Risk Minimisation Measures During the Life Cycle of Medicines in Europe

Autor Francisca, Reynold D. C., Baba, Emna, Hoeve, Christina E., Zomerdijk, Inge M., Sturkenboom, Miriam C. J. M., Straus, Sabine M. J. M.
Vydáno v Drug Saf (2020)

Population-based studies of antithyroid drugs and sudden cardiac death

Autor van Noord, Charlotte, Sturkenboom, Miriam C J M, Straus, Sabine M J M, Hofman, Albert, Witteman, Jacqueline C M, Stricker, Bruno H Ch
Vydáno 2009

Selective serotonin re-uptake inhibiting antidepressants and the risk of overanticoagulation during acenocoumarol maintenance treatment

Autor Teichert, Martina, Visser, Loes E, Uitterlinden, Andrė G, Hofman, Albert, Buhre, Peter J, Straus, Sabine, De Smet, Peter A G M, Stricker, Bruno HCh
Vydáno 2011

Pediatric Drug Safety Surveillance in FDA-AERS: A Description of Adverse Events from GRiP Project

Autor de Bie, Sandra, Ferrajolo, Carmen, Straus, Sabine M. J. M., Verhamme, Katia M. C., Bonhoeffer, Jan, Wong, Ian C. K., Sturkenboom, Miriam C. J. M.
Vydáno v PLoS One (2015)

Isotretinoin exposure during pregnancy: a population-based study in The Netherlands

Autor Zomerdijk, Ingeborg M, Ruiter, Rikje, Houweling, Leanne M A, Herings, Ron M C, Sturkenboom, Miriam C J M, Straus, Sabine M J M, Stricker, Bruno H
Vydáno v BMJ Open (2014)

EMA Recommendation for the Pediatric Indications of Plerixafor (Mozobil) to Enhance Mobilization of Hematopoietic Stem Cells for Collection and Subsequent Autologous Transplantatio...

Autor Karres, Dominik, Ali, Sahra, van Hennik, Paula B., Straus, Sabine, Josephson, Filip, Thole, Geanne, Glerum, Pieter J., Herberts, Carla, Babae, Negar, Herold, Ralf, Papadouli, Irene, Pignatti, Francesco
Vydáno v Oncologist (2020)

Understanding drug preferences, different perspectives

Autor Mol, Peter G M, Arnardottir, Arna H, Straus, Sabine M J, de Graeff, Pieter A, Haaijer-Ruskamp, Flora M, Quik, Elise H, Krabbe, Paul F M, Denig, Petra
Vydáno v Br J Clin Pharmacol (2015)

Enhancing Pharmacovigilance Capabilities in the EU Regulatory Network: The SCOPE Joint Action

Autor Radecka, Anna, Loughlin, Louise, Foy, Mick, de Ferraz Guimaraes, Margarida Viana, Sarinic, Viola Macolic, Di Giusti, Marina Dimov, Lesicar, Marina, Straus, Sabine, Montero, Dolores, Pallos, Julia, Ivanovic, Jelena, Raine, June
Vydáno v Drug Saf (2018)