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Data sources in post-authorization surveillance


Post-authorisation Safety Studies

Signal Management

Risk Management and Risk minimization

Engagement of consumers and patients

Meet the training leader

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

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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Join us in Amsterdam

Amsterdam is colloquially known as Venice of the North, because of its lovely canals that criss-cross the city, its impressive architecture and more than 1,500 bridges. There is something for every traveler's taste here, whether you prefer culture and history, serious partying, or just the relaxing charm of an old European city.

Early Bird Price

Delegate Fee

Special price is valid until 31st October 2019.

from 1996 € 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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