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IS IT OFF-LABEL USE OR MEDICATION ERROR - INTO THE UNKNOWN?
Session Chair(s)
Carla Schoonderbeek
Lawyer, Partner
Hoyng Monegier, Netherlands
GVP Annex I defines ADRs, off-label use, medication errors, and misuse. Specific MedDRA terms are available to code these medical concepts, but, based on available information, term selection for coding may not always be obvious. This session will address regulatory expectations and challenges in applying these definitions for ICSRs and implications for PSURs. Focus will be on practical and legal aspects of categorising, monitoring, and assessing medication errors, misuse, and off-label use and how to identify and implement opportunities to prevent them.
Speaker(s)
IS IT OFF-LABEL USE OR MEDICATION ERROR - INTO THE UNKNOWN?
Sarah Branch
MHRA, United Kingdom
Deputy Director, VRMM Division
The Challenges and Pitfalls of Off-Label and Other Unlicensed Use of Medicines
Alexander Meier
Novartis Pharma AG, Switzerland
Global Head Legal TechOps, Regulatory & Development
How the Expanded Definition of AE is Helping Pharmacovigilance
Georgy Genov, MD
European Medicines Agency, Netherlands
Head of PHV Office, ad-interim Head of Quality & Safety of Medicines Department
Making the Pharmacy an Even Safer Place to Get Medicines
John Chave, LLM
PGEU, Belgium
Secretay General
Panel Discussion
Rob Camp
EUPATI Spain, Spain
Director, International Patient Collaboration
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