Nordic Pharmacovigilance Day

Sharing Current Best Practices and Strategic Approaches within Pharmacovigilance Regulated Activities

The Nordic Pharmacovigilance Day has become a very popular forum for a broad range of professionals engaged in strengthening the safety of medicinal products and medical devices.

The 8th edition will build on the experiences from previous successful conferences presenting a program covering the current most important topics and challenges encountered within the pharmacovigilance area. Knowledgeable experts will provide excellent updates in key areas, covering recent advances in technology, science and legislation, as well as practical aspects. Sessions will be interactive and participants will be able to ask questions, engage in a dialogue and also share their own experiences.

Among others, we will cover the following topics:

• Inspections
  • Industry and regulatory perspectives, including IT perspective
  • Current trends including special features during the pandemic
• Medical device and combination product – the PSUR document
• Pharmacovigilance requirements post-Brexit (e.g. PSMF)
• Artificial Intelligence
  • AI & Machine Learning
  • AI applied in signal detection and safety data analysis
• Outsourcing of pharmacovigilance tasks
• Pharmacovigilance operations in Headquarters vs. Affiliate

Who should attend?
The conference program is designed for healthcare professionals or pharmacists in safety surveillance units in the pharmaceutical industry or regulatory agencies, either as specialists or managers, QPPVs, inspectors and QA personnel including auditors, employees in regulatory affairs units with close relations to pharmacovigilance, sponsors, vendors and CROs, representatives from patient organizations.

Scientific Board
Wasim Anwar, Vice President & Deputy QPPV - Head of QPPV Office, Global Safety at Novo Nordisk A/S
Caroline Sandstroem, Senior Specialist GCP/GLP/GVP, Compliance Global QA R&D at Ferring Pharmaceuticals
Doris Irene Stenver, Independent Pharmacovigilance Adviser, Founder of Unique Advice

The Conference is planned to be a one-day on-site event located in Copenhagen, unless the current state-of-play of the Covid-19 pandemic only allows for a on-line event.