We are happy to announce our upcoming pharmacovigilance training under the title (Signal Management – Detection and Data Mining). It will be conducted by Dr. Thamir Alshammari, a well-known Saudi PV expert. You may find below an intro about the training, brochure download, and the registration form.
Looking forward to seeing you in 15 & 16 March 2023 at the Mövenpick Hotel and Residences. For registration, click here.
A safety signal is information on a new or known adverse event that may be caused by a medicine and requires further investigation. Internationally, regionally and locally, all regulatory authorities worldwide and in Arab regulatory authorities (RAs) stressed in their pharmacovigilance guidelines and circulars the importance of
understanding and knowing the methods of signal management. In addition, all current pharmacovigilance guidelines in Arab countries have a specific module for signal management. Furthermore, some authorities are requesting a monthly report of the signals for each pharmaceutical company to be sent to them. Both pharmaceutical companies and regulatory authorities require signal management, and it is also part of several pharmacovigilance activities such as risk management plans, periodic safety update reports, and the main one, which is the individual case safety report. Several methods are used for signal detection, including the World Health Organization (WHO) – Uppsala Monitoring Center (UMC) causality assessment, Naranjo methods, Bayesian and others.
Dr Thamir Alshammari is a consultant in pharmacovigilance and one of the experts in the Middle East. He also specializes in pharmacoepidemiology and clinical trials. He was the director of the pharmacovigilance and drug safety centre at the SFDA. He is the first Saudi to have completed a post-doctoral fellowship in epidemiology and pharmacovigilance at the Food and Drug Administration (FDA) in the United States. He was selected as one of the distinguished experts worldwide for the Xian Center for Drug Safety and Policy Research in China until 2022. He is the president of the Middle East chapter of the International Society of Pharmacovigilance. He has done several training courses nationally and internationally in PV. Dr.AIshammari has over 110 publications in the same area.
Day 1
Time | Topic |
8:30-9:00 | Welcoming and introduction |
9:00-:09:45 am | Terminology and principle signal management |
09:45-10:45 am | Signal management regulation and requirements |
10:45- 11:00 am | Break |
11:00 am- 12 pm | Causality assessment and data theories |
12:00-01:00 pm | Prayer and Lunch break |
01:00- 03:00 pm | Disproportionality measures and data mining |
03:00- 04:00 pm | Hands-On practice |
Day 2
Time | Topic |
9:00-:10:30 am | First methods of signal management |
10:30-11:00 am | On-hand practice |
11:00- 11:15 am | Break |
11:15 am-12:30 pm | Second method of signal management |
12:30-01:00 pm | hands-On practice |
01:00- 02:00 pm | Prayer and Lunch break |
02:00- 03:00 pm | Third method of signal management |
03:30- 04:00 pm | Hands-On practice |
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