Public webpage on summary of product characteristics (SmPC) - PowerPoint PPT Presentation

Feb 07, 2023 •226 likes •287 views

Public webpage on summary of product characteristics (SmPC) PCWP-HCP WG joint meeting, 28 February 2012 Laurent Brassart Medical Information Information Compliance and Consistency An agency of the European Union Background

Public webpage on summary of product characteristics (SmPC) PCWP-HCP WG joint meeting, 28 February 2012 Laurent Brassart Medical Information – Information Compliance and Consistency An agency of the European Union
Background • Information on benefit-risk of medicines: patients', consumers' and healthcare professionals' expectations (10/ 07/ 2009) – To optimise regulatory information • SmPC Guideline implementation plan • Revision of the template of package leaflet • EPAR usability project – To inform about the role of the regulatory authorities (e.g. where to find information on benefits and risks, where data come from) • Involvement of Patients and Healthcare Professionals Organisations in the review of SmPC and package leaflet 1
SmPC implementation plan A cost-effective tool to facilitate harmonised review of SmPC within the regulatory network 2
Why a public access to the webpage? • Share training material with pharmaceutical industry • Support Healthcare Professional or Patients Organisations’ involvement in the review of SmPC or Package leaflet • Increase HCPs’ knowledge on SmPC • Contribute to public awareness of regulatory information 3
Future public webpage • Same content as EudraSmPC webpage except Query&Answer system which supports regulatory review process. – Update of training presentations + on-demand webinars • New presentations: – “SmPC: what is it and what does it contain?” – A draft presentation is being circulated for your input – Future presentations • Package Leaflet • Elderly population and SmPC information • Other suggestions? 4

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