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ePI videos
Videos about creating and managing ePI in the PLM portal
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ePI Registration Guide
Information on ePI roles in the PLM portal and how to request them
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ePI user guide for applicants
Instructions for ePI Applicant Managers and Contributors to navigate the authoring tool and create, prepare and submit ePI to regulators
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ePI Frequently Asked Questions (FAQs)
Common questions, known limitations, and current workarounds, where applicable
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ePI Release notes
What is new or changed in each release, including new features, enhancements, and resolved issues
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ePI User Guide for Regulators
Instructions for ePI Approvers and Publishers to navigate the tool and approve and publish ePI after they have been submitted by a pharmaceutical company
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ePI FHIR Implementation Guide
Preview of the FHIR Implementation Guide for ePI to enable creation of ePI according to the EU ePI Common Standard
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ePI Style Guide
This style guide aims to instruct applicants on how styling information is added for ePIs.
- ePI QRD template lists
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ePI Guidance documents and training material
Practical guidance, training materials, and supporting resources to enable effective use
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