Event info
Date:18 Sep, 2025
Time:08:30
Venue:Medicon Valley Alliance, Copenhagen

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Contact person
Mia Ritterband-Rosenbaum

Mia Ritterband-Rosenbaum

Event Manager & PA to CEO

mrr@mva.org

+45 21 63 38 88

Regulatory digital initiatives in the EU

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

 

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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)
TBD, Cencora 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.
Hanna has held key roles in the Finnish Medicines Agency and various pharmaceutical companies, enhancing regulatory processes and compliance. Currently, Hanna leads the service line of Regulatory Informatics within Regulatory Affairs with several development and client projects as her responsibility.

 

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