It is our great pleasure to invite you to participate at the “Baltic Regulatory Affairs Virtual Conference 2024. ePI Today and Tomorrow: Challenges, Opportunities and Benefits” on the 7th of November 2024 at 10.00-15.15 EET (9.00-14.15 CET).
AGENDA
Session I
| Time | Title | Lecturer |
|---|---|---|
| 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 | QA | |
| 12.20-13.00 | Lunch break |
Session II
| Time | Title | Lecturer |
|---|---|---|
| 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 | QA | |
| 15.10 – 15.15 | Final words |
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