5 -Training and educational capacity to build competencies
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
EPTRI (AISBL) - European Paediatric Translational Research Infrastructure (Association Internationale Sans But Lucrative) |
|
| Evidence of collaboration with regulatory authorities | Yes | Some of the Institutions supporting/part of EPTRI are Regulatory Agencies such as: 1. National Institute of Pharmacy and Nutrition of Hungary (OGYÉI), Hungary. 2. Medicines Evaluation Board (CBG - MEB), The Netherlands. |
| Capacity to provide competent consultation to regulatory authorities | Yes | 1. EPTRI participated in the pharmaceutical legislation revision for the review of the Paediatric Regulation. EPTRI played a significant role throughout this process, contributing to consultations, drafting position papers, and proposing amendments. Some EPTRI proposals were incorporated into the revised texts approved by the European Parliament in April 2024, including the creation of a Paediatric Medicines Working Group and improved readability of European Public Assessment Reports (EPARs), user-friendly information on medicines and the waiver system for PIP reform based on the medicinal product mechanism of action. |
| Formal meetings for clinical trials | No | N.A. |
| Training courses given over the last 2 years | Yes | The EPTRI Medical Device Research Platform has organised a one year online educational programme based around specific topics relating to child health technologies such as regulation, compliance, commercialisation and funding. Similar training plans are under development within the other Thematic Research Platforms. |
| Training courses received over the last 2 years | Yes | Partecipation to webinars organized by the EPTRI Members. |
| Promotion of participation in clinical trials in countries with limited resources | Yes | Albania |
| List of Countries |