7 th annual m eeting of Enpr-EMA m em bers, 2 9 .0 5 .1 5 Presented - - PowerPoint PPT Presentation

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7 th annual m eeting of Enpr-EMA m em bers, 2 9 .0 5 .1 5 Presented - - PowerPoint PPT Presentation

Dec 04, 2023 11 likes •105 views

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

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SLIDE 1

An agency of the European Union

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 Paediatric Medicines Office

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SLIDE 2

Regulatory background

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  • 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

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Project overview

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  • Report key m essages :
  • High quality research
  • Availability of medicines for children
  • Informing on paediatric use of medicines

Jul 2013 Apr 2016 Interim 5 Year Report 1 0 Year Qualitative Report (Data cut-off Dec 2015) Jan 2017 Update to 1 0 Year report (including data from 2016)

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SLIDE 4

I dentification of Perform ance I ndicators ( PI s)

  • By PIs Working Group (EMA-PDCO): to establish a list of PIs to measure outcomes
  • f 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.

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SLIDE 5

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I ndicator 1: Num ber of contacts each netw ork has had w ith industry re PI P trials only

PI P AND CLI NI CAL TRI AL RELATED I NFORMATI ON ORI GI N OF REQUEST TYPE OF I NVOLVEMENT OF THE NETW ORK CHI LDREN, PARENTS OR FAMI LI ES I NVOLVEMENT Year

( start of the trial; m ust be betw een 2 0 0 7 -2 0 1 6 )

Trial title EudraCT num ber PI P num ber ( if know n) Nam e of trial sponsor ( i.e. nam e of pharm aceutical com pany/ SME) Request for Netw ork involvem ent com ing from I ndustry directly or via the Enpr- EMA secretariat Please specify Advice given by Netw ork to I ndustry re PI P design ( e.g. definition of therapeutic needs, standard of care) Please specify Advice given by the Netw ork to I ndustry re PI P im plem entation ( e.g. feasibility of requested trials) Please specify Advice given by Netw ork to I ndustry re trial protocol design of a PI P ( e.g. acceptability

  • f clinical endpoints)

Please specify Active participation of Netw ork in conduct of clinical trial through enrolm ent of patients Please specify I nvolvem ent of children, parents or fam ilies in the trial design, developm ent of inform ed consent form s, or other? Please specify

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I ndicator 2: I nput from the Netw ork on paediatric treatm ent/ care guidelines

I m pact on paediatric treatm ent / care guidelines W hen did this occur? Year Title of paediatric clinical treatm ent / care guideline This guideline w as new ly- created? This guideline m akes reference to a study( ies) that are

  • ngoing in the context
  • f a PI P?

This guideline m akes reference to results / data from a com pleted study( ies) that is a PI P? I n case the guideline m ade reference to results / data from a com pleted study( ies) that is a PI P: W hich level of evidence w as assigned to the results / data? 5

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SLIDE 7

Additional free text question – not part of 1 0 Y Report

CONDUCT OF PAEDI ATRI C CLI NI CAL TRI ALS BY NETW ORKS

Funding Support Access to clinical expertise Access to inform ation from the Regulatory Setting Any other aspects you w ish to report; please specify I t w orks w ell Please specify I t can be im proved Please specify 6

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
  • nly on how to potentially improve the Paediatric Regulation but also to

improve their performance, structure and organisation

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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

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SLIDE 9

Many thanks in advance for your contribution to this project !

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