EMA/213044/2018

Agenda of the 2018 annual meeting of Enpr-EMA members and Coordinating Group meeting Friday 08 June 2018, meeting room 03-A

Chairpersons: Mark Turner / Irmgard Eichler Item

Agenda

09.00

Open session with industry observers

09:00

Welcome and introduction of new Enpr-EMA

Topic leader

Action

Mark Turner

For discussion

network members: •

NETSTAP e.V.

•

TREAT-NMD

•

HunPedNet

•

European Academy of Paediatric Research in Ambulatory Settings Network EAPRASNET

09:20

Outcomes of the 10th annual workshop 2018

Mark Turner

For information

09:40

Industry perspective & proposals for Enpr-EMA

Taube Tillman (tbc)

For discussion

action plan 2018/2019

John Watson (tbc) Martine DehlingerKremer

10:00

Interaction with European Reference Networks (ERNs)

o

How to best work with ERNs

10:30

Scientific Conferences 2018/2019

10.35

Coffee break

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

Mark Turner,

For discussion

Luca Sangiorgi

For information

An agency of the European Union

© European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged.

Item

Agenda

Topic leader

Action

10:50

Closed session for Enpr-EMA network

Mark Turner

For discussion

Interaction of Enpr-EMA with Conect4Children

Mark Turner/Irmgard

For discussion

(c4c)

Eichler

members only 10:50

11:20

12:00

Interaction between networks and stakeholders:

•

o

Data sharing

o

Data governance

o

Pilot to test draft model

o

How to best work with c4c

o

Define scope and role of c4c and EnprEMA representing networks that are not part of c4c Interaction Contract Research Organisations (CROs) – public benefit organisations – networks

• 12:15

• 12:35

For discussion

Irmgard Eichler

Enpr-EMA membership criteria

Enpr-EMA/PDCO interactions: •

Mark Turner

Marek Migdal

First experience with regular meetings

Alessandro Zuddas,

with PDCO

Wolfgang Goeppel,

How to expand in future

Network wish list for Enpr-EMA action plan

For discussion

Mark Turner (tbc)

All networks

For discussion

2018/2019 12:50

PDCO perspective & proposals

Angeliki Siapkara

For discussion

13:00

Enpr-EMA action plan for 2018/2019

Mark Turner

For discussion

13:15

Communication of difficulties with paediatric

Gunter Egger

For information

Mark Turner

For information

studies to PDCO 13:20

Conclusions and next steps

13:30

Close of Network Meeting

13:30

Lunch

Agenda of the 2016 annual meeting of Enpr-EMA members EMA/213044/2018

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Item

Agenda

Topic leader

14:15

Closed session Coordinating Group

Mark Turner/Irmgard

meeting

Eichler

Adoption of the minutes of last Coordinating

Mark Turner/Isabel

Group teleconference on 14 March 2018.

Perez

Endorsement of Enpr-EMA membership criteria

Mark Turner/Irmgard

14:15

14:20

Action

For agreement

For agreement

Eichler 14:30

Endorsement of newly received applications

Irmgard Eichler

For agreement

Irmgard Eichler

For information

Irmgard Eichler

For information

for Enpr-EMA membership:

14:40

•

NETSTAP e.V.

•

TREAT-NMD

•

HunPedNet

Notification of need for selection of new chair of Enpr-EMA at 2019 annual face-to-face meeting

14:50

Next Enpr-EMA CG teleconference to be scheduled in October 2018

14:55

A.O.B

15:00

End of meeting

Agenda of the 2016 annual meeting of Enpr-EMA members EMA/213044/2018

All

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