19 October 2016 EMA/642660/2017 Human Medicines Research & Development Support Division

Agenda - Enpr-EMA Coordinating Group & networks meeting Wednesday 25 October 2017, EMA room 03-H and via Adobe Connect; 15.00 to 17:00 UK time Chairpersons: Mark Turner / Irmgard Eichler Item

Agenda

Topic leader

15:00

Adoption of agenda

Mark Turner

For adoption

5’

15:05

Update on work plans and feedback on

Irmgard Eichler /

For information

70’

progress from each Enpr-EMA working group

Mark Turner

Mark Turner

For information

10’



WG on ethics & collaboration with EUREC



WG on young patient advisory groups



WG on educational training for research

Time

Chairs of working groups

staff on paediatric clinical trials •

WG on paediatric clinical trials with antibiotics

16:15



WG on clinical trial preparedness



WG on public-private partnership (pilot of guidance to industry)

Proposal for pan-European IMI2 paediatric network

16:25

Update on emerging networks outside EU

Mark Turner

For information

5’

16:35

Enpr-EMA contribution to public consultation

Mark Turner

For information

5’

on the reflection paper on the use of

(Saskia de Wildt)

For information

30’

extrapolation in the development of medicines for paediatrics 16:40

AOB •

10-year report on Paediatric Regulation

30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact

Irmgard Eichler / Mark Turner

An agency of the European Union

© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.

Item

Agenda •

Ethics-EUREC WG kick-off meeting



Data Anonymisation meeting November

Topic leader

Time

30th •

Annual Workshop 2018



ERANET in Personalised Medicine to open in December 2017

• 17:00

Next CG teleconference

End of meeting

Agenda - Enpr-EMA Coordinating Group members meeting, 6 October 2016 EMA/642660/2017

Page 2/2

Agenda - Enpr-EMA Coordinating Group & networks meeting

Oct 19, 2016 - network. Mark Turner. For information 10'. 16:25 Update on emerging networks outside EU. Mark Turner. For information 5'. 16:35 Enpr-EMA contribution to public consultation on the reflection paper on the use of extrapolation in the development of medicines for paediatrics. Mark Turner. (Saskia de Wildt).

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