19 October 2016 EMA/642660/2017 Human Medicines Research & Development Support Division
Agenda - Enpr-EMA Coordinating Group & networks meeting Wednesday 25 October 2017, EMA room 03-H and via Adobe Connect; 15.00 to 17:00 UK time Chairpersons: Mark Turner / Irmgard Eichler Item
Agenda
Topic leader
15:00
Adoption of agenda
Mark Turner
For adoption
5’
15:05
Update on work plans and feedback on
Irmgard Eichler /
For information
70’
progress from each Enpr-EMA working group
Mark Turner
Mark Turner
For information
10’
•
WG on ethics & collaboration with EUREC
•
WG on young patient advisory groups
•
WG on educational training for research
Time
Chairs of working groups
staff on paediatric clinical trials •
WG on paediatric clinical trials with antibiotics
16:15
•
WG on clinical trial preparedness
•
WG on public-private partnership (pilot of guidance to industry)
Proposal for pan-European IMI2 paediatric network
16:25
Update on emerging networks outside EU
Mark Turner
For information
5’
16:35
Enpr-EMA contribution to public consultation
Mark Turner
For information
5’
on the reflection paper on the use of
(Saskia de Wildt)
For information
30’
extrapolation in the development of medicines for paediatrics 16:40
AOB •
10-year report on Paediatric Regulation
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
Oct 19, 2016 - 15.00 to 17:00 UK time. Chairpersons: Mark Turner / Irmgard Eichler. Item. Agenda. Topic leader. Time. 15:00 Adoption of agenda. Mark Turner.
Apr 28, 2017 - 2. The United Kingdom will then become a 'third country'. 3. Preparing for the withdrawal is therefore not just a matter for EU and national authorities, but also for private parties. In view of the considerable uncertainties, in parti
May 30, 2017 - Pharmaceutical companies are invited to present their pre-clinical data pertaining to ... patients per year, as many questions about the best use of ALK ... of knowledge and evidence to support the planning and regulatory.
Mar 8, 2018 - Treatment of uterine fibroids. Haematology. New medicines authorised. ⢠Adynovi (rurioctocog alfa pegol). Treatment and prevention of bleeding in patients with haemophilia A. New information on authorised medicines. ⢠Feraccru (ferr
Jan 26, 2017 - is an antiparasitic medicine that treats the Varroa mite infestation in honey-bee colonies, which is considered to be the most significant parasitic ...
Treatment of cystine crystal deposits in the eye. New information on authorised medicines. Lucentis (ranibizumab) - change in indication. Treatment of visual ...
The new EudraVigilance system and the electronic reporting of individual case ... the ISO/ICH E2B(R3) format: hands-on training course - October 2017 ... granted a conditional marketing authorisation on the basis of less complete clinical data ...
4 days ago - EMA/CAT/426129/2018. Page 2/17. Table of contents. 1. Introduction. 5. 1.1. Welcome and declarations of interest of members, alternates and ...
Sep 8, 2016 - 3-year report on Pharmacovigilance activities. Helen Lee, European Commission. â¢. Scanning the horizon for 2016 â 2018. Peter Arlett, EMA.
PCWP and HCPWP joint meeting - Sept 2016 - meeting documents. ⢠Workshop on identifying opportunities for 'big data' in medicines development and ...
Used for the management of hypovolaemia (low blood volume) caused by acute (sudden) blood loss .... EMA's Business Continuity Plan for Brexit published.
On arriving for your meeting at 30 Churchill Place, please report to reception where you will be issued with an access pass. This pass will allow you to enter our industry lounge, which you are welcome to utilise during your visit. The industry loung
RSS feeds you need one of the following: a modern web browser; a web-based news reader or a ... Withdrawal of applications for new medicines .... fifth annual regulatory conference on optimising the development of advanced therapies to.
Jan 26, 2017 - is an antiparasitic medicine that treats the Varroa mite infestation in honey-bee colonies, which is considered to be the most significant parasitic ...
RSS feeds you need one of the following: a modern web browser; a web-based news reader or a desktop news reader. For a list of RSS readers please refer to ...
Windows is either a registered trademark or a trademark of Microsoft Corporation in the United States and/or other countries. Mac is a trademark of Apple Inc.
Jun 18, 2018 - 27. 7.8.1. List of all applications submitted/expected and the COMP coordinatorship distribution of .... 5,10-dihydrodibenzo[b,e][1,4] diazepin-11-one, EMA/OD/031/10 Glutathione-pegylated ...... Abbreviations / Acronyms.
Windows is either a registered trademark or a trademark of Microsoft Corporation in the United States and/or other countries. Mac is a trademark of Apple Inc.
European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged. 13 September 2017. EMA/727763/2017. Human Medicines Evaluation Division. List of nationally authorised medicinal products. Active substance(s): dexlansop
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 22, 2016 - Information Management Division ... This document provides current information related to the volume and evaluation of .... Plasma master file.
