Baltic Regulatory Affairs Virtual Conference 2024. ePI Today and Tomorrow: Challenges, Opportunities and Benefits
Organizing team, Estonia:
- Aet Raukas, Novartis
- Iivi Ammon, Bayer
- Kairit Karbus, AbbVie
- Merit Aava, Novartis
- Piret Metsala, Association of Pharmaceutical Manufacturers in Estonia
- Moderator Kristin Parts, SpeakSmart
- Sirli Peepson, Association of Pharmaceutical Manufacturers in Estonia, Contact: sirli.peepson@rtl.ee, +372 5566 4868
AGENDA
Session I
10.00 – 10.10 Welcoming Words from the Moderator – Kristin Parts, SpeakSmart
10.10 – 10.20 Opening Address – Heleni Mäe, Legal Advisor, Estonian State Agency of Medicines
10.20 – 10.50 EFPIA Views on How to Future-proof the EU General Pharmaceutical Legislation – What Roles Does the Electronic Product Information Play? – Sini Eskola, Director Regulatory Strategy, EFPIA
10.50 – 11.20 ePI for Human Medicines in the EU by EMA – a Look into the Future – Dr Juan Garcia Burgos, Head of Public and Stakeholders Engagement Department, EMA and Elizabeth Scanlan, Scientific Communication Officer & ePI Product Owner, EMA
11.20 – 11.50 ePI for Human Medicines in the EU by EMA – Piloting Experience from the Netherlands – Astrid Kragt, RA Senior Manager, Novartis NL
11.50 – 12.15 Gravitate Health ePI Project: Progress and Achievements – Anne Moen, Gravitate Health
12.15 – 12.20 Q&A
12.20 – 13.00 Lunch break
Session II
13.00 – 13.25 Norwegian Experience: Building Public Awareness on ePI – Paving the Way for the Future – Dag R. Jordbru, Strategic Director, Norwegian Medical Products Agency (NOMA)
13.25 – 13.50 Spanish Experience: ePIL at the Health Authority’s Website – Evinn Drusys, ePI co-Product Owner, AEMPS
13.50 – 14.15 Development and Use of ePI in Spain – AEMPS CIMA, Industry View – Ana Medina Guerrero, Farmaindustria
14.15 – 14.40 Results of a Survey in Estonia on Attitudes Towards Packages Without Paper PIL and Readiness to Use ePIL – Aet Raukas, RA Team Lead, Novartis EE
14.40 – 15.05 Dialogue with a Patient – Janek Kapper, Estonian Chamber of Disabled People and Kristin Parts, SpeakSmart
15.05 – 15.10 Q&A
15.10 – 15.15 Final words