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

Agenda

Topic leader

Minutes

Open agenda 13:00

Adoption of agenda

Mark Turner

The agenda was adopted without changes

13:05

Feedback on updated

Irmgard

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

Turner

since the last face to face meeting in May.

William Treem

Presentation

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.

13:50

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

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

Item

Agenda

Topic leader

Minutes

13:55

Update on

Irmgard

It was discussed that networks whose financial

Eichler

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

multi-stakeholder

will not be able to participate at multi-stakeholder

meetings •

meetings.

networks’ financial

A reminder with this information to be sent to all

disclosure to collect

networks.

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

preparedness”

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

14:08

Update on: •

PDCO: how to work /communicate with

Mark Turner

FinPedMed, NIHR CRN-Children and RIPPS to

/Irmgard

present during the November 2016 PDCO plenary

Eichler

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

(PHARMACHILD study)

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.

14:20

How to prepare for the

Gunter

Public consultation planned to start in November

corporate response to

Egger/Mark

2016 for a three-month period.

public consultation of

Turner

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-

Irmgard

Trial preparedness, then one topic in one

EMA working group

Eichler / Mark

particular therapeutic area , e.g. RSV; other

meetings 2017

Turner

suggestions were antibiotics, oncology, rheumatology.

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

Page 2/5

Item

Agenda

Topic leader

Minutes

14:35

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

issues?

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

14:45

Next Enpr-EMA CG and

Irmgard

WG teleconferences to

Eichler

Doodle poll to be sent for second half of January

be scheduled in January 2017 Close agenda 14:47

Propose topics for

Irmgard

A dedicated slot to discuss among national

network specific slot in

Eichler / Mark

networks to share best practices, funding models,

the annual f2f meeting

Turner

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

Irmgard

A few additional aspects (e.g. change of

factors influencing

Eichler

sponsor/CRO) to be considered in the project

successfully completed

planning were suggested.

paediatric clinical studies. 14:57

Endorsement of newly

Irmgard

received or updated

Eichler

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

EAPRASnet

report

(category 4) •

NorPedMed (category 3)

15:00

15:10

Revised self-

Irmgard

Networks requested to submit their suggestions

assessment forms

Eichler

within 1 month in writing.

Grouping of

Mark Turner /

While broad participation is considered beneficial

networks for joint

Irmgard

for sharing information, keeping a limited number

representation

Eichler

of participants is more efficient for decision



within CG:

making.

RIPPS/ CICPed

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

Page 3/5

Item

Agenda •

Topic leader

Minutes

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

Teleconferences?

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.

15:15

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.

15:20

End of meeting

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

Page 4/5

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

NIHR-MCRN FinPedMed MCRN-NL MICYRN ScotCRN CICPed RIPPS OKIDS DCRI

Oncology (solid / haematologic malignancies)

Newcastle-CLLG ITCC IBFMSG

Allergology / Immunology/ Rheumatology

PRINTO

Stem Cell and Organ Transplantation / Haematology (non-

EBMT

malignant) / Haemostaseology Respiratory diseases / Cystic Fibrosis

ECFS-CTN

Psychiatry / Neurology

EUNETHYDIS

Infectious diseases / Vaccinology

PENTA-ID UKPVG

Neonatology

GNN

Special Activities (pharmacovigilance, long-term follow up,

FIMP-MCRN

community paediatricians)

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

Page 5/5

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

Nov 10, 2016 - Send a question via our website www.ema.europa.eu/contact. © European ... Human Medicines Research & Development Support Division. Minutes .... networks to share best practices, funding models, organizational ...

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