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
o Pilot to test draft model ... Endorsement of Enpr-EMA membership criteria Mark Turner/Irmgard. Eichler ... Endorsement of newly received applications.
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 ...
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.
Jun 15, 2016 - Agenda - EMA Human Scientific Committees' Working. Parties with Healthcare Professionals' Organisations. (HCPWP) meeting. 15 June 2016, 08:45hrs to 10:30hrs â meeting room: 3E. Chairs: I. Moulon (EMA) and Gonzalo Calvo (HCPWP). 15 Ju
Feb 9, 2018 - 30 Churchill Place â Canary Wharf â London E14 5EU â United Kingdom. An agency of the European Union ... product information. For information: Summary of opinion. 2.2. Oral explanations and list of outstanding issues. â¢. Product
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
17 Jan 2018 - Expert meeting on adeno-associated viral vectors, 06 September 2017, EMA, London. CAT: Martina SchüÃler-Lenz. Scope: report of the meeting that took place on 6 September 2017. Action: for adoption. 7.6.3. Environmental assessment of g
Dec 7, 2016 - publication of clinical data (Policy 0070) and revisions to the guidance to industry â Industry Associations Webinar. 9 December 2016, 10:00 to ...
Sep 19, 2017 - 14:00-14:05. 2. Data integrity â early signal detection. - data patterns/trends in data ... 16:20-17:00. 5. Inspections of Ligand Binding Assays (in.
Nov 7, 2017 - 30 Churchill Place â Canary Wharf â London E14 5EU â United Kingdom. An agency of the European Union. Telephone ...... Visualisation of choline metabolism in malignant neoplasms ..... A paediatric investigation plan (PIP) is a dev
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
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.
Jun 14, 2016 - 30 Churchill Place â Canary Wharf â London E14 5EU â United Kingdom ... EMA initiatives to support and accelerate early access. 10:00 2.1 ...
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 ...
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
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
Nov 3, 2016 - Scope: 'Optimising the development of ATMPs to meet patient needs' ... the CAT would like to discuss with company representatives in person.
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 ...
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
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
Aug 1, 2016 - 15 June 2016, 11:00hrs to 16:30hrs â meeting room: 3E ... hosting a workshop that represents the culmination of the consultation process that ...
