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 7-th of November 2024 at 10.00-15.15 EET (9.00-14.15 CET).
In Europe, the acceleration in the digitalization of healthcare is impressive, and one feature is the implementation of electronic product information for medicines. We are living the period of soon to come amendment to pharma legislation and transition from paper to ePI.
Virtual (on-line) participation at the conference is free, link will be sent to participants.
Please register here: https://forms.gle/bXwWSRzyzynN8vWj6.
Moderator Kristin Parts, SpeakSmart.
The organiser reserves the right to make changes in the agenda.
AGENDA
Session I
| Time | Title | Lecturer |
|---|---|---|
| 10.00 – 10.10 | Welcoming Words from the Moderator | |
| 10.10 – 10.20 | Opening Address | Heleni Mäe, Estonian State Agency of Medicines Legal Advisor |
| 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 |
