European Medicines Agency - Regulatory - Regulation of medicines

3 - Specific competencies and capacity to provide export advice



    Description

Name

 

NETSTAP e.V. - Network of National Paediatricians in Germany

Number of peer reviewed publications in the last 5 years 9 see list of publication (Send by Bernhard Sandner)
Number of competitive grants obtained in the last 5 years 0 input for study design, inclusion of subjects, writing by single co-authors (see single publication)
Access to expert groups Yes depending on study respectively
Capacity to answer external scientific questions Yes internal advisory board of investigators who have at least 5 years experience in the performance of clinical studies
Site feasibility Yes standarised feasibility questionaire procedure which is adjusted for each study
Participant recruitment Yes regular investigator meetings and telephone conferences with investigators during recruitment phase
Budget calculation for studies Yes budget calculation is based on GOÄ (Gebührenverordnung für Ärzte) and part of each contract negotiation (confidential)