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

Page 2/3

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

Page 3/3

Agenda - European Medicines Agency - Europa EU

o Pilot to test draft model ... Endorsement of Enpr-EMA membership criteria Mark Turner/Irmgard. Eichler ... Endorsement of newly received applications.

123KB Sizes 7 Downloads 169 Views

Recommend Documents

Agenda - European Medicines Agency - Europa EU
Jul 7, 2017 - COMMUNITY MARKETING AUTHORISATIONS AND EXTENSIONS. 2.1. Opinions ... Quality. Rapp: E. Werner .... solutions table with EMA and CVMP responses to the recommendations made by the FishMed Plus. Coalition ...

Agenda - European Medicines Agency - Europa EU
Jun 19, 2017 - and may also vary during the course of the review. ...... ViiV Healthcare UK Limited; Treatment of Human Immunodeficiency Virus ..... adjunctive administration of brivaracetam, Treatment of paediatric patients with partial.

Agenda - European Medicines Agency - Europa EU
Jun 15, 2016 - Agenda - EMA Human Scientific Committees' Working. Parties with Healthcare Professionals' Organisations. (HCPWP) meeting. 15 June 2016, 08:45hrs to 10:30hrs – meeting room: 3E. Chairs: I. Moulon (EMA) and Gonzalo Calvo (HCPWP). 15 Ju

Agenda - European Medicines Agency - Europa EU
Jun 26, 2018 - oxadiazole-3-carboximidamide - EMEA-002072-PIP01-16-M01 . ..... Human alpha-galactosidase A - Orphan - EMEA-001828-PIP01-15-M01 .

Agenda - European Medicines Agency - Europa EU
Jul 16, 2018 - Cladribine, EMA/OD/087/17 Recombinant monoclonal antibody to sialic acid-binding Ig-like lectin 8. 2.2.6. - EMA/OD/098/18. Treatment of ...

Agenda - European Medicines Agency - Europa EU
Feb 9, 2018 - 30 Churchill Place ○ Canary Wharf ○ London E14 5EU ○ United Kingdom. An agency of the European Union ... product information. For information: Summary of opinion. 2.2. Oral explanations and list of outstanding issues. •. Product

Agenda - European Medicines Agency - Europa EU
Oct 23, 2017 - Page 2/61. Table of contents. 1. Introduction. 11. 1.1. Welcome and declarations of interest of members, alternates and experts .......... 11. 1.2. Agenda of the meeting on 23-26 October 2017 . ...... different database to study the ri

Agenda - European Medicines Agency - Europa EU
17 Jan 2018 - Expert meeting on adeno-associated viral vectors, 06 September 2017, EMA, London. CAT: Martina Schüßler-Lenz. Scope: report of the meeting that took place on 6 September 2017. Action: for adoption. 7.6.3. Environmental assessment of g

Agenda - European Medicines Agency - Europa EU
Dec 7, 2016 - publication of clinical data (Policy 0070) and revisions to the guidance to industry – Industry Associations Webinar. 9 December 2016, 10:00 to ...

Agenda - European Medicines Agency - Europa EU
Sep 19, 2017 - 14:00-14:05. 2. Data integrity – early signal detection. - data patterns/trends in data ... 16:20-17:00. 5. Inspections of Ligand Binding Assays (in.

Agenda - European Medicines Agency - Europa EU
Nov 7, 2017 - 30 Churchill Place ○ Canary Wharf ○ London E14 5EU ○ United Kingdom. An agency of the European Union. Telephone ...... Visualisation of choline metabolism in malignant neoplasms ..... A paediatric investigation plan (PIP) is a dev

Agenda - European Medicines Agency - Europa EU
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

Agenda - European Medicines Agency - Europa EU
Oct 24, 2017 - Application of Article 8(2) of the Orphan Regulation ..... propoxy)-phenyl]-methanone, EMA/OD/187/14 Herpes simplex type 1 virus containing.

Agenda - European Medicines Agency - Europa EU
Jun 14, 2016 - 30 Churchill Place ○ Canary Wharf ○ London E14 5EU ○ United Kingdom ... EMA initiatives to support and accelerate early access. 10:00 2.1 ...

Agenda - European Medicines Agency - Europa EU
6 days ago - EMA/OD/103/14 Donor T lymphocytes depleted ex vivo of host alloreactive T cells using photodynamic treatment, EMA/OD/175/14 Allogeneic ...

Agenda - European Medicines Agency - Europa EU
Jan 23, 2018 - HCP/patient cross-sectional survey and retrospective chart review Post Authorisation. Safety Study to evaluate the effectiveness of the Patient Alert Card for both IV and SC abatacept in a sample of EU countries. Positive Opinion adopt

Agenda - European Medicines Agency - Europa EU
Jan 8, 2018 - Some of the information contained in this agenda is considered commercially confidential or sensitive and therefore not disclosed. ... EU referral procedures for safety reasons: urgent EU procedures 13. 2.1. ...... clinical data from st

Agenda - European Medicines Agency - Europa EU
Nov 3, 2016 - Scope: 'Optimising the development of ATMPs to meet patient needs' ... the CAT would like to discuss with company representatives in person.

Agenda - European Medicines Agency - Europa EU
Jul 7, 2017 - EMEA/V/C/002526. Rapp: G. J. Schefferlie. For adoption: CVMP assessment report on the targeted. PSUR for the period 11.02.14-31.12.16 ...

Agenda - European Medicines Agency - Europa EU
Oct 23, 2017 - under Article 107i of Directive 2001/83/EC, based on pharmacovigilance data. Action: For adoption of ..... manufacturing process; and 3) removal of the following missing information: special patient groups. Action: For .... analysis of

Agenda - European Medicines Agency - Europa EU
Sep 20, 2016 - Send a question via our website www.ema.europa.eu/contact. © European ... 20 September 2016, 08:30hrs to 16:30hrs – meeting room: 2A.

Agenda - European Medicines Agency - Europa EU
Aug 1, 2016 - Send a question via our website www.ema.europa.eu/contact. © European ... Agenda - Developing a framework of collaboration between EMA ...

Agenda - European Medicines Agency - Europa EU
Jan 8, 2018 - information (RSI) adopted in July 2017. Action: For adoption of advice to CHMP. 7.2.15. Naltrexone hydrochloride, bupropion hydrochloride - MYSIMBA (CAP) -. EMEA/H/C/003687/MEA 004.4. Applicant: Orexigen Therapeutics Ireland Limited. PR

Agenda - European Medicines Agency - Europa EU
Aug 1, 2016 - 15 June 2016, 11:00hrs to 16:30hrs – meeting room: 3E ... hosting a workshop that represents the culmination of the consultation process that ...