Draft Agenda of the 2018 annual workshop of the European network of paediatric research at the EMA (Enpr-EMA) Date: Thursday 7 June 2018, room 03-A

Chairpersons: Mark Turner / Irmgard Eichler Item

Agenda

Action

Time

09:00

Arrival and registration

30’

09:30

Welcome address

5’

09:35

Session 1 Update on Enpr-EMA activities

09:35

Report from the coordinating group (CG)

For information

20’

For discussion

75’

For discussion

60’

Update on Enpr-EMA activities, achievements and challenges 09.55

Session 2 Update on the Enpr-EMA Working Groups

09.55

Feedback from each Working Group on their completed actions, deliverables and identification of follow-on action plans: • WG on GCP Training • WG on Ethics • WG Young People advisory groups • WG on trial preparedness • WG interaction network-industry-regulators

11.10

Update on networks: European networks: TEDDY

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

An agency of the European Union

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

Item

Agenda

Action

Time

For information

15’

European Child & Adolescent Psychopharmacology Network –ECAPN EAPRASnet (European Academy of Paediatrics Research in Ambulatory Settings network) Central European Pediatric Oncology Early Trials Alliance (CEPOETA) North American network: Duke Clinical Research Institute Institute for Advanced Clinical Trials for Children (I-ACT for Children) 12.10

Update on implementation of Clinical Trial Regulation

12.25

Lunch

13.30

Session 3

60’ For discussion

Holistic approach to paediatric research Perspective of various stakeholders: Young people advisory and patient groups

7’

Industry

7’

Paediatric Clinical Trial Networks

7’

European Reference Networks

7’

Learned societies: European Society of Paediatric

7’

Research National Paediatric associations/societies: The European

7’

Academy of Paediatrics Regulators

7’

Clinical Trial Facilitation Group

7’

Health technology assessment bodies

7’

Ethics committees

7’

Example for multi-stakeholder collaboration: Pulmonary

10’

arterial hypertension in children 15.15

Coffee break

15’

15.30

General discussion

60’

How to avoid duplication/ ensure synergies of various organisations

Draft Agenda of the 2018 annual workshop of the European network of paediatric research at the EMA (EnprEMA) EMA/198030/2017

Page 2/3

Item

Agenda

Action

Time

How to allow good communication How to divide the work between groups Challenges of clinical trials in (ultra) rare diseases 16.30

Action points and conclusions

Draft Agenda of the 2018 annual workshop of the European network of paediatric research at the EMA (Enpr-EMA) EMA/198030/2017

Page 3/3

Draft Agenda of the 2018 annual workshop of the European network of ...

Update on Enpr-EMA activities. 09:35. Report from the coordinating group (CG). Update on Enpr-EMA activities, achievements and challenges. For information.

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