1 0 Year Report to the European Com m ission on the public health effects of the Paediatric Regulation: request for data collection from the Enpr-EMA netw orks May 2 0 1 5 7 th annual m eeting of Enpr-EMA m em bers, 2 9 .0 5 .1 5 Presented by Benjam in Pelle & I rm gard Eichler An agency of the European Union Paediatric Medicines Office
Regulatory background Art. 5 0 of Reg. (EC) No 1901/ 2006 By Jan 2017 the Commission shall present a report to the Parliament on the experience from Articles 36, 37 and 38 (rewards and incentives) Measuring the 1 0 year im pact on paediatric research, availability of authorised medicines and better information on medicines Based on data collected from EMA and MS Report to EC on the public health effects of the Paediatric Regulation 1
Project overview Jul 2013 Apr 2016 Jan 2017 Interim 5 Year 1 0 Year Qualitative Update to 1 0 Year Report Report report (including data (Data cut-off Dec from 2016) 2015) Report key m essages : • High quality research • Availability of medicines for children • Informing on paediatric use of medicines 2
I dentification of Perform ance I ndicators ( PI s) By PIs Working Group (EMA-PDCO): to establish a list of PIs to measure outcomes of the work done by PDCO in achieving objectives of the Regulation (EC) 1901/ 2006 Comprehensive list of PIs (n= 51) As part of this comprehensive list, identification of 2 PIs related to Enpr-EMA networks: I ndicator 1 : Number of contacts each network has had with industry re PIP trials only I ndicator 2 : Input from the Network on paediatric treatment/ care guidelines Preparation of questionnaires for data collection by the Enpr-EMA networks on these 2 PIs. Questionnaires have been updated further to Enpr-EMA chair review. 3
I ndicator 1: Num ber of contacts each netw ork has had w ith industry re PI P trials only ORI GI N OF REQUEST PI P AND CLI NI CAL TRI AL RELATED I NFORMATI ON TYPE OF I NVOLVEMENT OF THE NETW ORK CHI LDREN, PARENTS OR FAMI LI ES I NVOLVEMENT Advice given by Netw ork Advice given by the Advice given by Request for Netw ork Active participation of to I ndustry re PI P design Netw ork to I ndustry Netw ork to I ndustry re I nvolvem ent of children, parents or fam ilies in the involvem ent com ing from Netw ork in conduct of Year Nam e of trial sponsor ( i.e. ( e.g. definition of re PI P im plem entation trial protocol design of trial design, developm ent of inform ed consent PI P num ber ( if I ndustry directly or via the clinical trial through Trial title EudraCT num ber nam e of pharm aceutical therapeutic needs, ( e.g. feasibility of a PI P ( e.g. acceptability form s, or other? know n) Enpr- EMA secretariat enrolm ent of patients ( start of the trial; m ust be com pany/ SME) standard of care) requested trials) of clinical endpoints) betw een 2 0 0 7 -2 0 1 6 ) Please specify Please specify Please specify Please specify Please specify Please specify 4
I ndicator 2: I nput from the Netw ork on paediatric treatm ent/ care guidelines I m pact on paediatric treatm ent / care guidelines I n case the guideline m ade reference to results / data from a com pleted study( ies) This guideline m akes that is a PI P: reference to a This guideline m akes W hen did this occur? Title of paediatric This guideline study( ies) that are reference to results / data W hich level of evidence w as clinical treatm ent / care w as new ly- ongoing in the context from a com pleted assigned to the results / Year guideline created? of a PI P? study( ies) that is a PI P? data? 5
Additional free text question – not part of 1 0 Y Report CONDUCT OF PAEDI ATRI C CLI NI CAL TRI ALS BY NETW ORKS Access to clinical Access to inform ation from the Any other aspects you w ish to report; Funding Support expertise Regulatory Setting please specify I t w orks w ell Please specify I t can be im proved Please specify This info is not directly relevant for the 10 year report but the questions have been designed with a benefit for the networks: • It could help them to document their achievements / performance • It could help them to analyse lessons learnt and make concrete proposals not only on how to potentially improve the Paediatric Regulation but also to improve their performance, structure and organisation 6
Tim elines Post Enpr-EMA members meeting: spreadsheets to be sent out to all Networks By m id Novem ber 2 0 1 5 : Networks to complete spreadsheets for the 2 defined PIs, for the period 2007 to 2015 EMA to analyse data provided and draft 10 year qualitative report to EC by April 2016 By m id Novem ber 2 0 1 6 : Networks to complete same spreadsheets for the 2 defined PIs, for the year 2016 EMA to analyse data provided for year 2016 and draft update to 10 year qualitative report to EC, by April 2017 7
Many thanks in advance for your contribution to this project ! 8
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