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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 minization. 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

Data sources in post-authorization surveillance

PSURs / PSUSAs

Post-authorisation Safety Studies

Signal Management

Risk Management and Risk minimization

Engagement of consumers and patients

Key Takeaways

• Understand how the PRAC works

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

• Gain detailed knowledge of the complex referral procedure

• Pharmacovigilance in special populations & for rare diseases

• Post-authorisation including quality issues

• Explore best practices for implementation of risk minimization measures and their impact

• Learn about the PRAC approach to patient engagement

Special Features

• Former member of EMA's Pharmacovigilance Risk Assessment Committee (PRAC)  as your leading trainer

• All delegates will receive electronic course documentation

• Certificate of attendance

• 3 x Workshops

• Hands-on case studies & practical examples

• Interactive learning approaches

Work & practice your pharmacovigilance inspection readiness

Project & Porftolio Management in the Pharmaceutical Industry picture

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Ticket

Delegate Fee

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