This five-day training course also includes highlights and updates on the pharmacovigilance legislation and the latest news on the international harmonisation and standardisation activities in pharmacovigilance.
For the five key topics as outlined below, the learning objectives also include the ability to:
• Describe the expedited and periodic ICSRs reporting requirements in clinical trials and
post-marketing including the medical evaluation
• Understand the process of audits and inspections in pharmacovigilance
• Understand the principles of signal management
• Describe the components of the risk management
Key Topics
• Definitions and Methods in Pharmacovigilance
• Regulatory Aspects in Pharmacovigilance and Practical Examples
• Diagnosis of Adverse Drug Reactions
• Signal Detection and Signal Management
- Modern Technologies and Social Media
• Risk Management
Who Will Attend
This course will benefit professionals with minimum 1-2 year experience in Pharmacovigilance or adjacent functions, for example, PV Officers, PV Specialists, PV Experts, PV Coordinators,
Heads/Directors/Managers of Regulatory Compliance, Quality or Safety departments.
Level: Intermediate
For the five key topics as outlined below, the learning objectives also include the ability to:
• Describe the expedited and periodic ICSRs reporting requirements in clinical trials and
post-marketing including the medical evaluation
• Understand the process of audits and inspections in pharmacovigilance
• Understand the principles of signal management
• Describe the components of the risk management
Key Topics
• Definitions and Methods in Pharmacovigilance
• Regulatory Aspects in Pharmacovigilance and Practical Examples
• Diagnosis of Adverse Drug Reactions
• Signal Detection and Signal Management
- Modern Technologies and Social Media
• Risk Management
Who Will Attend
This course will benefit professionals with minimum 1-2 year experience in Pharmacovigilance or adjacent functions, for example, PV Officers, PV Specialists, PV Experts, PV Coordinators,
Heads/Directors/Managers of Regulatory Compliance, Quality or Safety departments.
Level: Intermediate
