ANNOUNCEMENT: Training for Pharmacovigilance

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ANNOUNCEMENT: Training for Pharmacovigilance

ANNOUNCEMENT: Training for Pharmacovigilance

In order to provide methodological assistance to the holder of the certificate of state registration of medicines and organizations implementing pharmacovigilance measures in the organization of the pharmacovigilance system, the Analytical Expertise Center is organizing an online training on pharmacovigilance on May 21, 2021. Registration for the training will last from May 4 to May 20, 2021.
Those wishing to participate in the training should send their name, surname, position, name of the organization they represent, contact phone number to [email protected].
You can get additional information about the training by calling + 99450246-93-64.

    Training program:


       1. 		 What is pharmacovigilance and its importance today
  1.  
 History of pharmacovigilance, basic concepts and objectives
  1.  
 Thalidomide tragedy
  1.  
 The WHO programme for  International Drug Monitoring 
  1.  
 Significance of side effects
  1.  
 Side effects
  1.  
 Classification of side effects
  1.  
 Side effects gradation by severity
  1.  
 Additional impact notification form
  1.  
 Reporting additional effects in the Republic of Azerbaijan
  1.  
 Methods of sending additional impact notification cards
  1.  
 What is the minimum information that needs to be reported?
  1.  
 Deadlines for issuers of IT notices
  1.  
 Letter of notification to the medical staff
  1.  
 Existing legislation on pharmacovigilance in Azerbaijan
  1.  
 Duties of the card holder
  1.  
 Reliable Pharmacovigilance Practice
  1.  
 Pharmacovigilance system
  1.  
 Pharmacovigilance system of the license holder
  1.  
 Required documents on pharmacovigilance (registration and re-registration, post-registration period)
  1.  
 Summary of pharmacovigilance system
  1.  
 Risk management system
  1.  
 Risk management plan (RIP) and structure
  1.  
 Requirements for submission of RIP
  1.  
 Periodic safety update reports (PSUR) 
  1.  
 Procedure for submission of PSUR 
  1.  
 Quality system in the pharmacovigilance system
  1.  
 Audit of the pharmacovigilance system
  1.  
 Inspection of pharmacovigilance system
  1.  
 Specially controlled  medicines 
  1.  
 Procedure for examination of pharmacovigilance documents of medicines (RIP, PSMF and PSUR)