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Pharmacovigilance challenges: hot topics in 2018

Wednesday, October 24th, 2018 - Copenhagen

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Pharmacovigilance challenges: hot topics in 2018

The 5th Nordic Pharmacovigilance Day provides an opportunity to learn more about latest developments in Pharmacovigilance (PV) and engage with peer members of industry, regulators and service providers. The event focuses on major topics that are currently impacting or on the verge of change for PV departments: EU case processing and EVDAS since the EudraVigilance changes last November. PV in non-interventional studies. Perspectives on implementing General Data Protection Regulation and an outlook towards changes on handling combination products with the new Medical Device Regulation. Global regulatory intelligence in the past year. New, anticipated updates to GVP module VI regarding social media and understanding requirements, benefits and challenges of pervasive data such as social media and patient health records.

Like in previous years, the day will be an intense dive into areas that matters, to get inspiration and insights - and provides excellent networking opportunities with other passionate PV professionals.

Scientific Board

Martin Holm-Petersen - CEO at Insife
Betina Østergaard Eriksen - Vice President, Safety Surveillance at Novo Nordisk
Bina Kramhøft Schack - Deputy QPPV & Director at H. Lundbeck

Who should attend?

This one-day conference is designed to benefit functional/technical professionals working in the pharmaceutical and health care system dealing with the Pharmacovigilance system, such as:

  • Safety and Pharmacovigilance dept.
  • Clinical operation dept.
  • Statistic dept.
  • Medical Affairs dept.
  • Regulatory Affairs dept.
  • Quality & Compliance dept.
  • Legal dept.

in Pharmaceutical and Biotech companies, Clinical Research Organizations (CROs) and public health centers.

Please click here to read the code of good conduct

Taking part in the event, you support “The Vase of Flowers” project

Vaso di Fiori

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