Module 12 Presentations

EMA Portfolio Value Streams

2023 and beyond roadmap

Product Lifecycle Management ➢ Product Lifecycle Management Portal incl. eAF, ePI and Product Data Management (PMS) User Interface ➢ Veterinary Union Product Database ➢ Product Data Management Services (PMS) ➢ Regulatory Procedure Management (RPM) and Expert Panels for Medical Devices (EXPAMED) ➢ Electronic Submission and Review Tools (incl. electronic submissions review tool, Common Repository and eCTD Standards) ➢ European Medicines Web Portal (Veterinary and Human) Research & Development ➢ Procedure Management(IRIS) ➢ Clinical Trial Lifecycle incl. CTIS ➢ Substance Management & Investigational Medicinal Products (IMPs) incl. SMS & EU-SRS ➢ Data Analytics – Knowledge Mining ➢ Data Analytics – Generation of Scientific Evidence (data analysis) ➢ Post-authorisation studies and data sources Catalogue incl. Real World Data Monitoring ➢ European Shortages Monitoring Platform (ESMP) and Critical Medical Device Shortages ➢ Human Pharmacovigilance ➢ Inspections ➢ Parallel Distribution ➢ New Veterinary Legislation Managing the Agency ➢ Network & Stakeholder Management ➢ Governance ➢ Employee Life Cycle ➢ EMA Smart Building ➢ Finance incl. new Fee Regulation Technology Lifecycle Management & Information Security ➢ Modernization of IT capabilities ➢ Information Security and Cybersecurity Enhancements ➢ Legislative and regulated requirements

Relevance for RA

Source: EMA Quarterly Strategic Portfolio Review Q3 2023 (Sept 6th)

The Organisation for Professionals in Regulatory Affairs

Feb 1st, 2024 – TOPRA Module 12