European Medicines Agency - Regulatory - Regulation of medicines

5 -Training and educational capacity to build competencies

    Description

Name

  

EUNETHYDIS - European Network for Hyperkinetic Disorders
Evidence of collaboration with regulatory authorities Yes Several members have had extensive experience contributing to and collaborating with regulatory authorities e.g. Prof. E. Taylor, UK MHRA, Prof. A. Zuddas, Italian ADHD Registry and Italian Regulatory Authority, Profs. Buitelaar & Sergeant, Advisors: Dutch Ministry of Health on ADHD, Prof. I. Wong, UK MHRA. The ADDUCE study (monitoring long term adverse effects of methylphenidate) was developed in collaboration with EMA and MHRA.
Capacity to provide competent consultation to regulatory authorities Yes See 5.1
Formal meetings for clinical trials Yes 10-15 per year for various trials, these include planning meetings for PIs, investigator meetings, training meetings for site staff, ongoing meetings regarding recruitment, rater reliability etc.
Training courses given over the last 2 years Yes Network members have provided trial specific training for both industry sponsored and publicly funded academci trials (e.g. STOP, PERS, ADDUCE).
Training courses received over the last 2 years Yes Network members have also received trial specific training for a range of industry sponsored trials. Network members also complete specific ICH GCP training course on a regular basis.
Promotion of participation in clinical trials in countries with limited resources Yes The network has involved several countries with limited resources in clinical trials and has encouraged industry partners to include such countries in their ADHD studies.
List of Countries  

Hungary, Poland, Portugal