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Real-time, instructor-led course

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Meet the training leader

  • Doris I. Stenver, MD, MPA
  • Independent Pharmacovigilance Adviser Founder of Unique Advice
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Course description

This training course will provide a unique insight into the functioning of the EU Pharmacovigilance Risk Assessment Committee (PRAC) and advice on how best to interact with this important committee. The focus will be on the procedures covered by the PRAC mandate, in particular on safety referrals, data sources in post-marketing surveillance and risk management and risk minimization. The program will also include an overview of new regulatory initiatives related to the COVID-19 pandemic. This interactive course is recommended for those who have some experience in pharmacovigilance and wish to develop their skills to enhance the safe & effective use of medicines.

Key topics

Risk management and impact on pharmacovigilance

EU safety referral procedures

The COVID19 pandemic – overview of regulatory initiatives

Key takeaways

Understand how the PRAC works

Get overview of the comprehensive EU legislation and guidance and the significant impact on pharmacovigilance strategies

Explore data sources and scientific methods utilized in post-authorisation surveillance

Gain detailed knowledge of the complex referral procedure

Discuss and work on a safety referral procedure

Learn about new regulatory initiatives related to the COVID-19 pandemic


Online Live Stream

from 1196 € Buy


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