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Announcement: Signal Management Workshop (March 2023 Riyadh)

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The Author

Regulatory Editor

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.

Overview

A safety signal is an 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 on 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. Signal management is required by both pharmaceutical companies as well as regulatory authorities 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 other methods.

Speaker

Dr. Thamir Alshammari

Dr. Thamir Alshammari, who is a consultant in pharmacovigilance and one of the experts in the middle East. He is also specialized in pharmacoepidemiology and clinical trials. He was the director of pharmacovigilance and drug safety center at the SFDA. He is the first Saudi who did his post-doctoral fellowship in the area of epidemiology and pharmacovigilance at the Food and Drug Administration (FDA) in the United States. He was selected to be one of the distinguished experts worldwide for the Xian center for drug safety and policy research in China till 2022. He is the president of the Middle East chapter at the international society of pharmacovigilance. He has done sever- al training courses nationally and internationally in PV. Dr.AIshammari has over 110 publications in the same area.

Workshop Objectives

  1. Understand the concept of signal management.
  2. Get familiar with the regulatory requirements for signal management.
  3. Know the concept and process of signal detection and causality assessment.
  4. Identify the differences between these methods.
  5. Know how to perform the calculations that are needed for some methods.
  6. Understand the steps of each methods and how applying the process for each method.

Ways of the workshop

  1. Presentations
  2. Hand-on individual practice
  3. Group discussion

Who Should Attend

  • Those who work in pharmacovigilance departments in, pharmaceutical companies, regulatory authorities, and hospitals in all middle east countries including  Saudi Arabia, GCC and other countries.
  • Pharmacists or Physicians

Program

Day 1

TimeTopic
8:30-9:00Welcoming and introduction
9:00-:09:45 amTerminology and principle signal management
09:45-10:45 amSignal management regulation and requirements  
10:45- 11:00 amBreak
11:00 am- 12 pmCausality assessment and data theories
12:00-01:00 pmPrayer and Lunch break 
01:00- 03:00 pmDisproportionality measures and data mining
03:00- 04:00 pmHands-On practice

Day 2

TimeTopic
9:00-:10:30 amFirst methods of signal management
10:30-11:00 amOn-hand practice
11:00- 11:15 amBreak
11:15 am-12:30 pmSecond method of signal management
12:30-01:00 pmhands-On practice   
01:00- 02:00 pmPrayer and Lunch break
02:00- 03:00 pmThird method of signal management
03:30- 04:00 pmHands-On practice  

Registration Fee

  • Early Bird Registration (Until 24 Feb 2023): SAR 5,750 (VAT Included)
  • Basic Registration (After 24 Feb 2023): SAR 6,325 (VAT Included)

Registration Form

Click here for registration

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