Regulatory Digital Initiatives in the EU – Key Challenges in Pharmaceutical Product Lifecycle Management
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📅 Wednesday, November 5
⏰ 8.30-10.30
📍 Forskaren (Floor 2)
Regulatory digital initiatives in the EU – Key challenges in pharmaceutical product lifecycle management
Topics will include:
- EMA initiatives and digital services; electronic application forms (eAF), IRIS-platform, and product management system (PMS)
- Regulatory data submission and reuse throughout the product lifecycle management
- Electronic Product Information (ePI), current state and target state
- Main opportunities and challenges on the regulatory data journey
Our speaker is Hanna Saari, Associate Director, Service Line Lead, Regulatory Informatics Services, Cencora PharmaLex.
Breakfast included.
Please note that photos will be taken at the event.