TY - STD TI - The story of UMC and the WHO Programme: https://www.who-umc.org/global-pharmacovigilance/who-programme/the-story-of-umc-and-the-who-programme/. Accessed 10 Mar 2019. UR - https://www.who-umc.org/global-pharmacovigilance/who-programme/the-story-of-umc-and-the-who-programme/ ID - ref1 ER - TY - STD TI - ICH. Pharmacovigilance Planning E2E .2005. https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E2E/Step4/E2E_Guideline.pdf. Accessed 10 Mar 2019. UR - https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E2E/Step4/E2E_Guideline.pdf ID - ref2 ER - TY - JOUR AU - Schwartzberg, E. AU - Berkovitch, M. AU - Nahlieli, D. D. AU - Gorelik, E. PY - 2017 DA - 2017// TI - Pharmacovigilance in Israel – tools, processes and actions JO - Israel Journal of Health Policy Research VL - 6 UR - https://doi.org/10.1186/s13584-017-0154-3 DO - 10.1186/s13584-017-0154-3 ID - Schwartzberg2017 ER - TY - STD TI - European Union. Regulation EC N° 1235/2010 of 15 Dec 2010 amending regulation 726/2004. Eurolex: https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:348:0001:0016:EN:PDF. Accessed 10 Mar 2019. UR - https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:348:0001:0016:EN:PDF ID - ref4 ER - TY - STD TI - EMA. Human Regulatory : Pharmacovigilance post-authorisation. https://www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance-post-authorisation. Accessed 10 Mar 2019. UR - https://www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance-post-authorisation ID - ref5 ER - TY - STD TI - ISOP: Chapters. https://isoponline.org/chapters/israel/. Accessed 10 Mar 2019. UR - https://isoponline.org/chapters/israel/ ID - ref6 ER - TY - STD TI - ISOP ISRAEL: International Symposium, 360° of drug safety. 3-4 June 2019. https://www.isopisrael2019.org. Accessed 10 Mar 2019. UR - https://www.isopisrael2019.org ID - ref7 ER - TY - STD TI - FDA: preventable adverse drug reactions: a focus on drug interactions. https://www.fda.gov/drugs/drug-interactions-labeling/preventable-adverse-drug-reactions-focus-drug-interactions. Accessed June 2019. UR - https://www.fda.gov/drugs/drug-interactions-labeling/preventable-adverse-drug-reactions-focus-drug-interactions ID - ref8 ER - TY - STD TI - EMA: Human Regulatory. European good Pharmacovigilance practices. Module V*: Risk management systems. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-module-v-risk-management-systems-rev-2_en.pdf. Accessed 10 Mar 2019. UR - https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-module-v-risk-management-systems-rev-2_en.pdf ID - ref9 ER - TY - STD TI - FDA: Risk Evaluation and Mitigation Strategies; Modifications and revisions; Guidance for Industry. 2015. https://www.fda.gov/media/91803/download. Accessed 10 June 2019. UR - https://www.fda.gov/media/91803/download ID - ref10 ER - TY - STD TI - FDA : Risk Evaluation and Mitigation Strategies Assessment: Planning and Reporting Guidance for Industry.2019. https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm629743.pdf.Accessed 10 Mar 2019. UR - https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm629743.pdf ID - ref11 ER - TY - STD TI - CIOMS: Management of Safety Information from clinical trials: report of CIOMS group VI. 2005. https://cioms.ch/shop/product/management-of-safety-information-from-clinical-trials-report-of-cioms-working-group-vi/.Accessed 10 Mar 2019. UR - https://cioms.ch/shop/product/management-of-safety-information-from-clinical-trials-report-of-cioms-working-group-vi/ ID - ref12 ER - TY - JOUR AU - Pitts, P. e. t. e. r. J. AU - Le Louet, H. e. r. v. é. PY - 2018 DA - 2018// TI - Advancing Drug Safety Through Prospective Pharmacovigilance JO - Therapeutic Innovation & Regulatory Science VL - 52 UR - https://doi.org/10.1177/2168479018766887 DO - 10.1177/2168479018766887 ID - Pitts2018 ER - TY - JOUR AU - Pitts, P. e. t. e. r. J. AU - Le Louet, H. e. r. v. é. PY - 2018 DA - 2018// TI - Advancing Drug Safety Through Prospective Pharmacovigilance JO - Therapeutic Innovation & Regulatory Science VL - 52 UR - https://doi.org/10.1177/2168479018766887 DO - 10.1177/2168479018766887 ID - Pitts2018 ER - TY - STD TI - IMSP: Institute for Safe Medication Practices. https://www.ismp.org/ . Accessed 10 Mar 2019. UR - https://www.ismp.org/ ID - ref15 ER - TY - STD TI - MIT: Nancy Leveson. http://sunnyday.mit.edu/. Accessed 10 Mar 2019. UR - http://sunnyday.mit.edu/ ID - ref16 ER - TY - JOUR AU - Leveson, N. AU - Couturier, M. AU - Thomas, J. AU - Dierks, M. AU - Wierz, D. AU - Psaty, B. M. AU - Finkelstein, S. PY - 2012 DA - 2012// TI - Applying system engineering to pharmaceutical safety JO - Journal of Healthcare Engineering VL - 3 UR - https://doi.org/10.1260/2040-2295.3.3.391 DO - 10.1260/2040-2295.3.3.391 ID - Leveson2012 ER - TY - STD TI - Couturier M.2010. in MIT http://sunnyday.mit.edu/Couturier-Thesis-Vioxx.pdf. UR - http://sunnyday.mit.edu/Couturier-Thesis-Vioxx.pdf ID - ref18 ER - TY - JOUR AU - Pitts, P. J. AU - Louet, H. AU - Moride, Y. AU - Conti, R. M. PY - 2016 DA - 2016// TI - 21st century pharmacovigilance: efforts, roles, and responsibilities JO - The Lancet Oncology VL - 17 UR - https://doi.org/10.1016/S1470-2045(16)30312-6 DO - 10.1016/S1470-2045(16)30312-6 ID - Pitts2016 ER - TY - STD TI - Data2Life. http://data2life.com/company/. Accessed 10 Mar 2019. UR - http://data2life.com/company/ ID - ref20 ER - TY - STD TI - Medware. http://www.medaware.com/. Accessed 10 Mar 2019. UR - http://www.medaware.com/ ID - ref21 ER - TY - STD TI - Mediseen. https://mediseen.com/. Accessed 10 Mar 2019. UR - https://mediseen.com/ ID - ref22 ER - TY - STD TI - Vaica. http://www.vaica.com/. Accessed 10 Mar 2019. UR - http://www.vaica.com/ ID - ref23 ER - TY - STD TI - European Union. Directive 2010/84 EC amending as regards pharmacovigilance Directive 2001,/83/EC. Official Journal of the European Union. https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:348:0074:0099:EN:PDF. Accessed 10 Mar 2019. UR - https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:348:0074:0099:EN:PDF ID - ref24 ER - TY - STD TI - Alliance for patient safety. http://www.allianceforpatientsafety.org/. Accessed 10 2019. UR - http://www.allianceforpatientsafety.org/ ID - ref25 ER - TY - STD TI - Cure medicine. https://www.cure-medicine.co.il/. Accessed 10 Mar 2019. UR - https://www.cure-medicine.co.il/ ID - ref26 ER - TY - STD TI - The Israeli society for patient safety and risk management in healthcare. https://isrm.doctorsonly.co.il/the-israeli-society-for-patient-safety-and-risk-management-in-healthcare-isrm/. Accessed 10 Mar 2019. UR - https://isrm.doctorsonly.co.il/the-israeli-society-for-patient-safety-and-risk-management-in-healthcare-isrm/ ID - ref27 ER - TY - STD TI - Senor D, Singer S. The start up nation: Hachette Book Group; 2009. ID - ref28 ER - TY - STD TI - Lubell M. Israel to launch big data health project. Reuters, World News. 2018. ID - ref29 ER - TY - STD TI - MSR: Israel Center for Medical Simulation. https://eng.msr.org.il/about_Msr. Accessed 10 Mar 2019. UR - https://eng.msr.org.il/about_Msr ID - ref30 ER -