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 | TEDDY participated and participates in many public consultations (e.g. guidelines, concept papers, reflection papers) with the EC, the EMA and the National Competent Authorities, such as: - Public consultation on "Summary of Clinical Trial Results for Laypersons" (August 2016) - Public consultation on the revision of "Ethical Considerations for Clinical Trials on Medicinal products conducted with Minors" (August 2016) - Survey for Enpr-EMA networks regarding Young Persons Groups (April 2016) - Contribution to the Enpr-EMA data collection for the 10 year report to the European Commission on the public health effects of the Paediatric Regulation (November 2015) - Contribution to the topic of transition from paediatrics to adults clinical care settings by providing documents on Thalassaemia and HIV infection patients (May 2015) - Enpr-EMA request for information to develop a Global Paediatric Clinical Trials Network (October 2014) - Stakeholder consultation for Horizon 2020 Societal Challenge "Health, demographic change and wellbeing" for the programming exercise 2016/2017 (September 2014) - Contribution to amendments proposed by GRiP (Global Research in Paediatrics, FP7- HEALTH – 2010-261060) to the draft Regulation on Clinical Trials on medicinal products for human use (May 2013) - Public consultation on the concept paper on the Revision of the 'Clinical Trials Directive' 2001/20/EC (February 2011) - Ethical Considerations for Clinical Trials Performed in Children (2007) - EMA Assessment of paediatric needs and Priority-List of Off-patent medicinal products for paediatric studies (2007, 2008) - Guideline on Conduct of Pharmacovigilance for Medicines used by the Paediatric Population (2006) - Draft guidance on ‘specific modalities’ for non-commercial clinical trials referred to in Commission Directive 2005/28/EC laying down the principles (2006) - Reflection Paper on the use of Pharmacogenetics in the pharmacokinetic evaluation of medicinal products (2006). |
| Capacity to provide competent consultation to regulatory authorities | Yes | Experts proposed by TEDDY are/have been members of: - Paediatric Committee (PDCO) - Committee on Herbal Medicinal Products (HMPC) - European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) - Paediatric Working Group at the Italian Medicines Agency (AIFA) - Paediatric Working Group at the Spanish Medical Agency (AEMPS) - Paediatric Expert Group at the German Medical Agency (BfArM) - European Society of Developmental Paediatric and Perinatal Pharmacology (ESDPPP) |
| Formal meetings for clinical trials | Yes | Investigators’ meetings and scientific project meetings are organized for each planned trial and scheduled before the starting and during all the crucial phases until the end of the trial. In addition TEDDY has prepared and makes available 19 e-learning courses aimed to increase the researchers awareness and capacity to conduct GCP paediatric trials. |
| Training courses given over the last 2 years | Yes | 1. DEEP Scientific Open Meeting “Challenges and Opportunities of conducting clinical trials in paediatrics” (Padua, Italy, April 15th, 2016) 2. Regulatory and practice in paediatric trials and studies (Warsaw, Poland, September 22nd-23rd, 2015) 3. Deep Scientific Open Meeting: Networking and innovation for local development (Tirana, Albania, May 18th, 2015) 4. Health and Biotechnology (Castellaneta Marina, Italy, October 2nd-4th, 2014) 5. Biotech and Innovative Science to meet Patient Needs (Bari, Italy, September 30th-October 2nd, 2013) TEDDY has set up an e-learning platform (available at www.teddylearning.org) and has distributed the following online courses, which are going to be updated in the framework of the SMART EU project (Horizon 2020): “Children are not little adults” • “The European Paediatric Regulation”; • “Paediatric status and off-label use of drugs in children”; • “Clinical trials involving children - Methodological aspects”; • “Clinical trials involving children - Ethical aspects”; • “Pharmacoepidemiology and drug utilisation in childhood”; • “Pharmacovigilance and drug adverse reactions in paediatrics”; • “Innovative medicines and orphan drugs for children”; • “Therapeutic needs in the paediatric population” . |
| Training courses received over the last 2 years | Yes | 1. Pharmacovigilance reports in clinical trials (AIFA training course, Rome 2-4 September 2013) 2. Workshop on Extrapolation and Evidence Synthesis in the Development and Therapeutic Use of Medicines in Children (Glasgow, 11 June 2013) 3. Online training course on Good Clinical Practice (March 2013) 4. EudraVigilance - Electronic Reporting of ICSRs in the EEA (EMA- London, 21-23 May 2012) 5. Extended EudraVigilance Medicinal Product Dictionary (XEVMPD) Training Course (London, 8-9 March 2012) |
| Promotion of participation in clinical trials in countries with limited resources | Yes | TEDDY studies involve clinical centres located in non-EU countries. Support is provided for implementation of European ethical and methodological high level standards. |
| List of Countries | Albania, Egypt, Tunisia |