ISoP offers a unique, highly focused, and scientific and interactive two-day seminar that will explore the emerging tools of potential interest for process automation in pharmacovigilance. Strengths, limitations, challenges for implementation and further evolutions will be debated among relevant specialists.

This seminar will take place at the Biogen Building 8 Auditorium, Cambridge, MA

The course will start on 4 December at 08.00 through to 17.00 and continue on 5 December at 09.00 through to 15.30.

Dr Jan Petracek, PrimeVigilance CEO and ISoP Board member is organising the seminar sharing expertise.

The increasing volume of regulated data management and data analysis activities in pharmacovigilance are very time consuming and costly, and process automation has potential to provide much higher efficiency and heavily reduced costs. However, process automation is a complex strategic decision, and needs to be evaluated correctly.

At the end of the seminar, pharmacovigilance leaders should be able to make enlightened decisions when dealing with potentially disruptive innovation.

This seminar is aimed to engage all interested pharmacovigilance professionals in an industry, regulatory, or university setting.

  • The programme will include the following topics:
    • Case intake automation
    • ICSR processing automation
    • Signal management and Risk management support tools
    • New skillset for career in Pharmacovigilance
    • Pharmacovigilance insourcing and outsourcing model for industry 4.0

The faculty for this course consists of international and national experts in pharmacovigilance, representing government, academia, and industry.

To register: ISoP website

For practical information, programm and registration forms are available please contact by E-mail: administration@isoponline.org

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