5 -Training and educational capacity to build competencies
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
Medicines for Children Research Network (MCRN) -Hungary |
|
| Evidence of collaboration with regulatory authorities | Yes | MCRN Hungary collaborates closely with the national regulatory agency (OGYEI). MCRN Hungary follows national and international regulatory guidelines and holds regular meetings with OGYEI. |
| Capacity to provide competent consultation to regulatory authorities | Yes | MCRN Paediatric Expert Advisory Group (PEAG) set up is in progress. The need for such an expert group has also been recognised by the national regulatory agency, therefore MCRN PEAG will provide scientific advice in regulatory affairs as well. |
| Formal meetings for clinical trials | Yes | Annual MCRN meetings |
| Training courses given over the last 2 years | Yes | MCRN Hungary in collaboration with Semmelweis University and OGYEI organized and provided a GCP course in Budapest in 2013. MCRN Hungary organized a very successful, internationally recognized Paediatric Medicines Conference with prestigous speakers from both sides of the Atlantic in Budapest in 2014. |
| Training courses received over the last 2 years | No | |
| Promotion of participation in clinical trials in countries with limited resources | No | |
| List of Countries |