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Online Live Training Features

All sessions of this unique course online

Live interaction options between the delegates and trainer

Available via mobile, tablet or laptop

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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 new ways of generating evidence, surveillance in special populations and initiatives aiming at strengthening patient engagement. This interactive course is recommended for those who have some experience in pharmacovigilance and wish to develop their skills to enhance the safe and effective use of medicines.

Key topics

Understand how the PRAC works

Get an overview of the comprehensive EU legislation, guidance and procedures

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

Gain detailed knowledge of the complex referral procedure

Discuss and work on a safety referral procedure

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Delegate Fee

from 1196 € Buy


Based on your specific needs and goals, we will build a training program that will equip your employees with the right set of skills and practical knowledge to achieve your organization's targets.

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