European Medicines Agency - Regulatory - Regulation of medicines

3 - Specific competencies and capacity to provide export advice



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

Number of peer reviewed publications in the last 5 years 3 Wahn, U. et al. High-dose sublingual immunotherapy with single-dose aqueous grass pollen extract in children is effective and safe: A double-blind, placebo-controlled study. (2012) JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY 130:886-94 Gossger, N. et al. Immunogenicity and Tolerability ofRecombinant Serogroup B Meningococcal Vaccine Administered With or Without Routine Infant Vaccinations According to Different Immunization Schedules A Randomized Controlled Trial. (2012) JAMA 307(6):573-582 Abrahamse-Berkeveld, M. et al. Infant formula containing galacto-and fructo-oligosaccharides and Bifidobacterium breve M-16V supports adequate growth and tolerance in healthy infants in a randomised, controlled, double-blind, prospective, multicentre study. (2016) J NUTR SCI. 5,e42:1-13
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)