5 -Training and educational capacity to build competencies
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
TEDDY - European Network of Excellence for Paediatric Research |
|
| Evidence of collaboration with regulatory authorities | Yes | 1. Accelerating Clinical Trials in the EU Multi stakeholders Platform 2. European Network of Centers for Pharmacoepidemiology and Pharmacovigilance (ENCePP) 3. European Network of Pediatric Research at EMA (Enpr-EMA) |
| Capacity to provide competent consultation to regulatory authorities | Yes | Experts proposed by TEDDY are / have been members of: 1. Accelerating Clinical Trials in the EU Multi stakeholders Platform 2. European Network of Centers for Pharmacoepidemiology and Pharmacovigilance (ENCePP) 3. European Network of Pediatric Research at EMA (Enpr-EMA) 4. Council of Europe |
| Formal meetings for clinical trials | Yes | 15 |
| Training courses given over the last 2 years | Yes | 6 1. Annual Open EnprEMA Workshop (hybrid) 2 October 2024 – Donato Bonifazi 2. iCAN Advocacy and Research Summit July 18-19 2024 in Bari 3. 2023 iCAN Summit in La Jolla, San Diego, California 4. Third Paediatric Expert Patients Training Workshop in collaboration with EURORDIS and the Sant Joan de Déu Research Foundation in the framework of the European Joint Programme on Rare Diseases (EJPRD)-Barcelona, Spain, from Wednesday 21st to Friday 23rd June 2023 5. Workshop on quality criteria/standards of paediatric clinical trial sites- The workshop, co-organised by Enpr-EMA and conect4children (c4c), was held virtually on October 3, 2022. 6. ICH-GOOD CLINICAL PRACTICE (GCP) TRAINING COURSE |
| Training courses received over the last 2 years | Yes | 9 1. c4c Advanced course on Paediatric Clinical-Nov 23-Feb 24 2. Clinical Study Protocols – Structure & Content- 3-5/04/2024 3. The 7th EUCROF Conference on Clinical Research. Pushing Boundaries and Accelerating Innovation - 19/02-20/02/24 4. Elements of Clinical Trials Methodologies (2nd ed.) - Mar-Apr 24 5. Ethics Committee Evaluation of Paediatric Clinical Trials - 29/04-03/06/24 6. Essentials of Paediatric Clinical Research-08/11/2023 7. c4c Paediatric GCP Basic- 06/02/2023 8. ICH-Good Clinical Practice E6 (R2)- 08/08/2023 9. ICH-Good Clinical Practice E6 (R2)- 01/06/2023 |
| Promotion of participation in clinical trials in countries with limited resources | Yes | TEDDY studies involve clinical centres located in non-EU countries. List: Albania |
| List of Countries |