About

“Hot topics”- increasing awareness of significant and essential needs in Pharmacovigilance

Thursday 24 October 2019 - Copenhagen

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“Hot topics”- increasing awareness of significant and essential needs in Pharmacovigilance

After the great success of the 5th Nordic Pharmacovigilance Day in 2018, the 6th edition will be another opportunity to discuss, deliberate and debate the latest operational and technological challenges in the Pharmacovigilance field.

Recent advances and perspectives in Pharmacovigilance (PV) will be shared during the meeting, with an emphasis on practical aspects and how-tos. The meeting brings together the major experts to share their knowledge with practical examples triggering engaging discussions and guiding participants’ efforts in the jungle of methods now available. The objective is to help and find solutions to the many challenges that, as a cross-functional development team in PV, must solve to maximize the new opportunities ahead of us.

This year’s event focuses on topics that currently have major impact on Pharmacovigilance related processes and activities such as, but not limited to:

  • Industry experiences from latest PV inspections
  • SDEAs and good pharmacovigilance outsourcing practices,
  • New technologies to improve PV related processes,
  • QPPV challenges and real-life experiences,
  • Reference Safety Information and Risk Management Plans.
  • PRAC Strategies to measure the Impact Factor of Pharmacovigilance
  • Signal detection in pharmacovigilance using EVDAS

Moreover, we will present perspectives on implementing General Data Protection Regulation and Clinical Trial Regulation.
During this one-day forum we will provide and discuss the best solutions for ensuring a patient focused future and to help drive success in your organization.

Scientific Board

Martin Holm-Petersen - CEO at Insife
Caroline Susanne Sandström Msc PhD - Senior Specialist GCP/GLP/GVP Compliance Global QA R&D at Ferring Pharmaceuticals A/S
Doris Irene Stenver, MD, MPA - Independent Pharmacovigilance Adviser, Founder of Unique Advice

Who should attend?

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

  • Safety and Pharmacovigilance dept.
  • Clinical operation dept.
  • Statistic dept.
  • Medical Affairs dept.
  • Medical Information dept.
  • Regulatory Affairs dept.
  • Quality & Compliance dept.
  • Legal dept.
  • Software Developing dept.
  • Medical Devices Manifacuring Companies
  • University Faculties scientists who are related to clinical and medical research (Senior, Associate and Assistant Professors, Research Scholars, Phd students).

Also, Directors/Seniors Directors/Executive Directors and Vice Presidents /Senior Vice Presidents/Executive Vice Presidents and Heads/Leaders/Partners of: CROs and CMOs, Clinical Research Sites, Pharma, Biotech and Medical Devices Industries.

Please click here to read the code of good conduct

A portion of the proceeds from this event are donated to the “Vase of Flowers” project

Vaso di Fiori

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