Saudi Vigilance Program: Challenges and lessons learned

Pharmacovigilance is vital to public health. Adopting a robust spontaneous reporting system for adverse drug events can counteract most hazards that arise from utilizing medicinal products. Prior to the establishment of the Saudi Food and Drug Authority (SFDA), the number of pharmacovigilance-related activities in Saudi Arabia was limited. In 2009, the SFDA established the National Pharmacovigilance and Drug Safety Center (Saudi Vigilance). The pharmacovigilance system has remarkably improved during the past few years. Several initiatives have been taken to improve the program’s performance. These initiatives include initiation of pharmacovigilance guidelines, enhancement of communication and reporting tools, training sessions for concerned staff and healthcare providers, and compliance from stakeholders. This review article provides an overview of what the Saudi Vigilance program is, focusing on the scope, mission and vision, hierarchy, operational themes, and overall work processes. Additionally, we will shed light on the challenges we encountered during the early phase and on our future plans

EVS Trend File 1981-2017 – Sensitive Dataset

The European Values Study is a large-scale, cross-national and longitudinal survey research program on how Europeans think about family, work, religion, politics, and society. Repeated every nine years in an increasing number of countries, the survey provides insights into the ideas, beliefs, preferences, attitudes, values, and opinions of citizens all over Europe. The EVS Trend File 1981-2017 is constructed from the five EVS waves and covers almost 40 years. In altogether 160 surveys, more than 224.000 respondents from 48 countries/regions were interviewed. It is based on the updated data of the EVS Longitudinal Data File 1981-2008 (v.3.1.0) and the current EVS 2017 Integrated Dataset (v.5.0.0). For the EVS Trend File, a Restricted-Use File (ZA7504) is available in addition to the (factually anonymised) Scientific-Use File (ZA7503). The EVS Trend File – Sensitive Dataset (ZA7504) is provided as an add-on file. In addition to a small set of admin and protocol variables needed to merge with the SUF data, the Sensitive Dataset contains the following variables that could not be included in the scientific-use file due to their sensitive nature: W005_3 Job profession/industry (3-digit ISCO88) - spouse/partner EVS 2008W005_3_01 Job profession/industry (3-digit ISCO08) - spouse/partner EVS 2017W005_4 Job profession/industry (4-digit ISCO88) - spouse/partner EVS 2008X035_3 Job profession/industry (3-digit ISCO88) – respondent EVS 1999, EVS 2008 X035_3_01 Job profession/industry (3-digit ISCO08) - respondent EVS 2017X035_4 Job profession/industry (4-digit ISCO88) – respondent EVS 1999, EVS 2008 x048c_n3 Region where the interview was conducted (NUTS-3): NUTS version 2006 EVS 2008X048J_N3 Region where the interview was conducted (NUTS-3): NUTS version 2016 EVS 2017X049 Size of town (8 categories) EVS 2008, EVS 2017 Detailed information on the anonymization process in the EVS Trend File is provided in the EVS Trend File Variable Report