Medicon Valley Alliance and Cencora PharmaLex are pleased to invite you to a Good Morning Meeting on the 18th of September 2025 in Copenhagen focusing on regulatory digital initiatives in the EU.
Let’s discuss about regulatory digital initiatives in the EU such as ePI, eAF, IRIS and PMS.
– 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
Date: Thursday 18th of September 2025
Time: 8:30 – 11:00
Venue: Medicon Valley Alliance, Arne Jacobsens Allé 15, 2300 Copenhagen S, Denmark – Hub 2
Program
| 8:30 | Networking, registration and light breakfast |
| 9:00 | Welcome and introduction to Medicon Valley Alliance David Munis Zepernick, Director, Member Engagement & Communication, Medicon Valley Alliance |
| 9:05 | Company introduction, PharmaLex (becoming Cencora) Åsa Pihlblad, Nordic Region Head, Cencora PharmaLex |
| 9:15 | EMA initiatives and regulatory data submissions Hanna Saari, Service Line Lead, Associate Director, Regulatory Informatics, Cencora PharmaLex |
| 9:40 | Electronic Product Information (ePI) Pirkko Talvio, Senior Director, Regulatory affairs Northern Europe at PharmaLex |
| 10:00 | Q&A session |
| 10:15 | Networking |
| 11:00 | End of Good Morning Meeting |
Speakers
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Hanna Saari, Associate Director, Service Line Lead, Regulatory Informatics Services, Cencora PharmaLex
Hanna has a master’s degree in pharmacy from the University of Helsinki and a BBA in business and administration. She has over 20 years of experience in regulatory data and digitalization. Her expertise spans electronic Common Technical Document (eCTD) submissions and EU data submissions, including xEVMPD and IDMP/UPD, always in either internal or external client facing position. |
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Pirkko Talvio, Senior Director, Regulatory affairs Northern Europe at PharmaLex
Pirkko Talvio is Senior Director, Regulatory affairs Northern Europe at PharmaLex. She has more than 30 years of experience in regulatory affairs for medicinal products spanning EU marketing authorization and lifecycle maintenance procedures as well as local Nordic regulatory affairs, launch and GDP activities.
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