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
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
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.
May 15, 2017 - malignancy under the age of 3 years: TBI is what really matters, Bone ..... primary care research network, but there is no formal affiliation.
May 15, 2017 - Analysis on Behalf of the Pediatric Disease Working Party of the .... participating researchers for analysis of clinical and biobank data once.
3 days ago - Of note, this agenda is a working document primarily designed for PRAC members and the work the. Committee .... New signals detected from EU spontaneous reporting systems . .... Risk management plans (RMPs). 17. 5.1.
May 14, 2018 - and dysplasia based on the final report of the OPUS registry (P04808): a prospective, observational, non-interventional, post-marketing safety ...
1 day ago - Some of the information contained in this agenda is considered commercially confidential or sensitive ... Of note, this agenda is a working document primarily designed for PRAC members and the work the ...... in patients with heart failur
Jan 25, 2018 - Quality DG . ... Cooperation within the EU regulatory network ....................................................... 8 ... Cooperation with International Regulators .
5 days ago - template (version 10), to update the list of local representatives in the package leaflet and to correct a translation error in the Polish, Finnish, Danish and Latvian versions. Action: For adoption of PRAC RMP AR, PRAC RMP assessment ov
Jun 11, 2018 - PRAC Rapporteur: Julie Williams. Scope: Evaluation of preliminary data ...... PRAC Rapporteur: David Olsen. Scope: PASS protocol for study ...
Sep 26, 2016 - 13 October 2016, 9:00 â 12:00, room 7/B, via teleconference. Health and safety information. In accordance with the Agency's health and safety ...
Mar 20, 2018 - 20 March 2018, 17:30- 19:00, room 3A. 21 March 2018, 08:30- 19:00, room 3A. 22 March 2018, 08:30- 19:00, room 3A. 23 March 2018, 08:30- 13:00, room 3A. Health and safety information ...... GlaxoSmithKline Trading Services Limited; Prim
Jan 23, 2018 - Some of the information contained in this agenda is considered commercially confidential or sensitive and therefore not disclosed. With regard to intended therapeutic indications or procedure scopes listed against products, it must be
Sep 26, 2016 - Send a question via our website www.ema.europa.eu/contact ... safety and emergency information and procedures prior to the start of the ...
Sep 1, 2017 - For information: WHO online consultation on the monitoring and ... Information relating to availability of medicines cannot be released at the ...
Sep 14, 2016 - List of letters of intent received for submission of applications with start of procedure .... Workshop on social media held on 19 September 2016 .
Sep 14, 2016 - Some of the information contained in this agenda is considered commercially confidential or sensitive and therefore not disclosed. With regard ...
2 days ago - Draft agenda for the meeting on 19-21 June 2018. Chair: Bruno ... be published in the COMP meeting reports once the procedures are finalised. Of note ...... products at time marketing authorisation extension. 24. 5.1. .... List of all ap
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 ...
Apr 24, 2018 - Horizon Pharma Ireland Limited; E72.2 Urea cycle disorders / indicated for use as adjunctive therapy for chronic management of patients with urea cycle disorders (UCDs) including deficiencies of carbamoyl phosphate-synthase-I (CPS), or
Apr 3, 2017 - 53. 12.8.3. PRAC workload statistics - Q1 2017 . ..... from an analysis of osteoporosis-related fracture data in subjects who discontinued ...
Mar 6, 2017 - Send a question via our website www.ema.europa.eu/contact ...... population to register Nplate for the use in the paediatric chronic immune ...
Apr 24, 2018 - Collaborative papers of PDCO with Rome Foundation on Irritable ..... thromboembolic events (children), acute coronary syndrome, history of.