Pharm Tech Agenda 2022.09.15

Agenda

Meeting Venue

Montreux

9:30 Welcome

• Review and Approve Agenda

14:00- 15:30 Adverse Event Reporting

- Adverse events There are two level of adverse events:

1. Reporting
2. Investigation.

Conclusion: Focus on the reporting part of adverse events. There are some adverse events reports that are mandatory on the national level in Switzerland. Conclusion: There is a need for adverse events on the national level. WHO want to give this more priority Action: we should ask the WHO to support the development of the logical data model for adverse events. OPEN IHE to support the transaction. Physicians are afraid that if they do the reporting they also need to do the investigation See an example of the Greece yellow carte: https://www.eof.gr/assets/KITRINI_KARTA.pdf

Number regarding adverse events:

1. According to Leonidas only 10% of the reaction are being reported in Greece.
2. In Portugal and Greece the doctors are the main source of the adverse events reports.
3. In the Netherlands the patients are also contributing to the reports.
4. In Austria the adverse events are not on the agenda. Hospitals have some things organised but the topic is not present due to other prioritisations.

Links to documents