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Bethesda North Marriott Hotel and Conference Center

Feb 06, 2023 1:00 PM - Feb 09, 2023 12:35 AM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Global Pharmacovigilance and Risk Management Strategies Conference

Stay current with the latest safety regulations from global health authorities and regulatory experts!

Exhibitor Sponsored Session/Non-CE: Case Study hosted by PharSafer

Session Chair(s)

  Sponsored Sessions

Sponsored Sessions

United States

Case Processing – The Most Important Part of Pharmacovigilance? Or Rubbish in, rubbish out!

In this session, we will review the current industry landscape for clinical and post marketing drug safety, identifying and highlighting the key issues that Companies face and how this influences safety data capture and processing activities, and analyse the subsequent impact this has on other pharmacovigilance activities (e.g. signal detection), regulatory inspection findings and compliance.

Further to this, we will also delve into the role of case processors and medical reviewers within the data intake and case processing arena and assess current industry practices, whilst also exploring the benefits of implementing an automated solution, and evaluate if a movement towards AI and innovation can provide an enhanced, more complete solution for other aspects of Pharmacovigilance including periodic report writing, signal identification and benefit-risk determinations.

Featured Topics:

  • Clinical and post marketing drug safety
  • AI and automation
  • Patient and reporter engagement
  • Safety data intake and case processing
  • Safety database, process, and systems optimization
  • Data accuracy and compliance
  • Signal detection
  • Risk management
  • Periodic report writing
  • Auditing and KPIs


Graeme  Ladds, PhD


Graeme Ladds, PhD

PharSafer, United Kingdom

CEO & Owner

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