10 November 2016 EMA/683953/2016 Human Medicines Research & Development Support Division

Minutes - Enpr-EMA Coordinating Group members meeting Thursday 06 October 2016, EMA room 03-K and via Adobe Connect; 13.00 to 15.20 UK time Chairpersons: Mark Turner / Irmgard Eichler Item


Topic leader


Open agenda 13:00

Adoption of agenda

Mark Turner

The agenda was adopted without changes


Feedback on updated


Members of the working groups present during

work plans and work

Eichler / Mark

this meeting gave brief updates on the work done

progress from each


since the last face to face meeting in May.

William Treem


Enpr-EMA WG 13:40

Industry chosen topic: IMI 2 project

Aim to build a pan-European paediatric clinical trials network. There was a multi-stakeholder workshop sponsored by the EC in April 2016.


Webinar on Enpr-EMA

John Watson

Presentation The objective of the webinar is to raise awareness for Enpr-EMA among SMEs and big pharma, 1 hour webinar scheduled for 24 November 2016. Gareth Veal and Kalle Hoppy to liaise with Mark Turner to prepare the joint presentation on what networks do and can offer. Post meeting note: The propose date is likely to be moved to December 2016 at the request of EUCOPE

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

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© European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged.



Topic leader



Update on


It was discussed that networks whose financial


disclosure is not made publicly available either on

EMA guidance for

the network’s website or by submitting the

organisation of

financial disclosure form to Enpr-EMA secretariat


will not be able to participate at multi-stakeholder

meetings •


networks’ financial

A reminder with this information to be sent to all

disclosure to collect


data on source of networks’ funding: Current status 14:05

Plan to establish Enpr-

Mark Turner

Agreed to plan a multi-stakeholder meeting next

EMA WG on “Trial

year on this topic, building on outcome of the


discussions at the EFGCP/DIA/EMA meeting in October; Potential deliverable “White paper”


Update on: •

PDCO: how to work /communicate with

Mark Turner

FinPedMed, NIHR CRN-Children and RIPPS to


present during the November 2016 PDCO plenary


their work, what they can offer, how they differ from CROs. PRINTO (proposed date January 2017)

networks •

will be invited to participate (via TC) to report on

Update from

experience with obtaining data post-authorisation

networks to provide


PDCO contact

PDCO to come up with list of questions they would

points •

like to have addressed by the networks during the

Update from

October PDO meeting.

networks re contact with learned societies 14:13

Update on PEDCRIN

Mark Turner

PEDCRIN will develop the paediatric capabilities of ECRIN, the European Clinical Research Infrastructure Network. PedCRIN has been awarded €3.3 million and will start work in January 2017.


How to prepare for the


Public consultation planned to start in November

corporate response to


2016 for a three-month period.

public consultation of


10 year report on

volunteers; currently Mark Turner and Saskia de

Paediatric Regulation 14:25

Small task force to prepare first draft : call for Wildt

Suggestions for 3 Enpr-


Trial preparedness, then one topic in one

EMA working group

Eichler / Mark

particular therapeutic area , e.g. RSV; other

meetings 2017


suggestions were antibiotics, oncology, rheumatology.

Agenda - Enpr-EMA Coordinating Group members meeting, 6 October 2016 EMA/683953/2016

Page 2/5



Topic leader



Feedback on meeting

Pirkko Lepola

It was agreed to proactively approach EUREC and

with EUREC: how to

invite Dirk Lanzerath to a TC with participation of

train Ethics Committees

Mark Turner, Irmgard Eichler and Pirkko Lepola

on paediatric specific

with any additional volunteers who are interested


to discuss how collaboration could be further pursued; 2 areas proposed: •

paediatric specific training for Ethics Committees members;

compilation of contact points/chairs of various national ethic committees among EU member states


Next Enpr-EMA CG and


WG teleconferences to


Doodle poll to be sent for second half of January

be scheduled in January 2017 Close agenda 14:47

Propose topics for


A dedicated slot to discuss among national

network specific slot in

Eichler / Mark

networks to share best practices, funding models,

the annual f2f meeting


organizational structures, etc... Kalle Hoppu volunteered to chair 1.5-(2) hour slot; proposed

without industry

time: after open workshop on day 1. 14:52

Project: analysis of


A few additional aspects (e.g. change of

factors influencing


sponsor/CRO) to be considered in the project

successfully completed

planning were suggested.

paediatric clinical studies. 14:57

Endorsement of newly


received or updated


applications for Enpr-

Need to clarify how NorPedMed as national Norwegian network is collaborating with the other

EMA membership: •

Endorsement agreed;

Nordic countries listed in their self-assessment



(category 4) •

NorPedMed (category 3)



Revised self-


Networks requested to submit their suggestions

assessment forms


within 1 month in writing.

Grouping of

Mark Turner /

While broad participation is considered beneficial

networks for joint


for sharing information, keeping a limited number



of participants is more efficient for decision

within CG:



Agenda - Enpr-EMA Coordinating Group members meeting, 6 October 2016 EMA/683953/2016

Page 3/5


Agenda •

Topic leader


Proposal: only have

The proposal to split agenda into a section with

one annual f2f CG

topics for discussion and information to which all

meeting and invite

networks are invited and then one closed section

all networks as

for category 1 networks as per mandate of the

observers to the

CG. The proposal to be re-discussed among Co-

other 2 CG

chairs and finalized before adoption at next CG


meeting in January. RIPPS currently representing French national networks will prepare minutes of this CG meeting to share with the other French national network CICPed.


Publishing updates on networks

Isabel Perez

Networks will be invited to submit their updates in a more harmonized structured format, limited to 1 page max which will then be published on the Enpr-EMA website annually.


End of meeting

Agenda - Enpr-EMA Coordinating Group members meeting, 6 October 2016 EMA/683953/2016

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List of Category 1 Enpr-EMA registered networks (20 networks):

Type of network and therapeutic area of the network

Name of category 1 network

National and multispecialty


Oncology (solid / haematologic malignancies)


Allergology / Immunology/ Rheumatology


Stem Cell and Organ Transplantation / Haematology (non-


malignant) / Haemostaseology Respiratory diseases / Cystic Fibrosis


Psychiatry / Neurology


Infectious diseases / Vaccinology




Special Activities (pharmacovigilance, long-term follow up,


community paediatricians)

Agenda - Enpr-EMA Coordinating Group members meeting, 6 October 2016 EMA/683953/2016

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Minutes of the European network of paediatric research at the ...

Nov 10, 2016 - Thursday 06 October 2016, EMA room 03-K and via Adobe Connect;. 13.00 to 15.20 UK .... paediatric specific training for Ethics. Committees ...

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