Here you will find the agenda for Regulatory Affairs 2024 event! Time will be allocated for questions, discussions, networking, and breaks throughout the day.
The times presented in the agenda are in Helsinki time.
Update 29.5.2024: Due to a strike in Norway the afternoon presentation "Multi-Language Labeling: Challenges and Solution" from Norwegian Medicines Agency has been cancelled and other presentations rescheduled.
9.30 Onsite registration starts, light breakfast available
10.00 Welcome & practical information
Ulla Partanen, Head of Learning Services, Pharmaca Health Intelligence
Moderator: Jonna Alhopuro, Nordic Regulatory Affairs Team Manager, Astra Zeneca
Theme 1: New EU Pharma legislation
10.15 Current Trends and Future Directions in EU Pharmaceutical Legislation - first viewpoint
Åsa Kumlin Howell, Head of International Affairs, Swedish Medical Agency
10.45 Current Trends and Future Directions in EU Pharmaceutical Legislation - second viewpoint
Sini Eskola, Director, Regulatory Strategy, EFPIA
11.15 Break
Theme 2: The Digital Future
11.35 Product management service (PMS) implementation
Hanna Saari, Head of EU Informatics, Associate Director, Regulatory Affairs, Cencora Pharmalex
11.55 DADI – How to use Digital Application Dataset Integration in Regulatory Processes
A follow up from 2022
Kristiina Puusaari , Digital Business Transformation Programme eSubmission Senior Coordinator, DADI product Owner, European Medicines Agency EMA
12.15 Lunch Break & Networking
13.20 Emerging Trends: The Role of AI in Regulatory Affairs
Antti "Andy" Törrönen, CEO, Kwork
14.00 Paperless PIL packs – piloting across borders in Baltic countries
Iivi Ammon, Regulatory Affairs Nordics, Bayer
14.25 Nordic co-operation & ePI Pilot
- Nordic co-operation in pharmaceutical information: common repository with FHIR ePI
- Nordic Gravitate Health project - Pilot findings on use of digital product information and future foreseeing
Essi Kariaho, CXO, Pharmaca Health Intelligence Oy
14.45 Case example Norway: Spreading the ePIL awareness for consumers
Bente Jansen, Cand.pharm., Managing director, Chief editor, Felleskatalogen AS
15.05 Coffee Break & networking
15.35 Theme 3: Panel discussion: Medicine Shortages
Moderator: Anna Ikonen, Quality Lead Nordics, Bristol Myers Squibb
Panelists:
- Roland Lidberg, Director Commercial Logistics, Astra Zeneca
- Johanna Linnolahti, Head of Section (Availability), Fimea
- Essi Kariaho, CXO, Pharmaca Health Intelligence Oy
16.20-16.35 Summary of the Day
Moderator of the day: Jonna Alhopuro, Nordic Regulatory Affairs Team Manager, Astra Zeneca
Ulla Partanen, Head of Learning Services, Pharmaca Health Intelligence
Please note that the event details are subject to updates, and participants are encouraged to check for any changes closer to the event date. We look forward to your active participation!
