EU Innovation Network Core profile within the network
An agency of the European Union
EU Innovation Network Membership New NCAs* from September 2016 to date The Czech Republic – October 2016 Germany (BfArM) – October 2016 Denmark – November 2016 Target: All Human Medicines NCAs Following Adoption of mandate in September 2016
from 28 MSs
22 NCAs
Norway – March 2017 Estonia – April 2017 Poland – April 2017 Croatia – May 2017
Pre-Adoption of mandate Sept 2016 15 NCAs
* Please note that changes to appointed EU-IN members representing NCAs Innovation Offices are not highlighted here. 1
EU Innovation Network - Core profile within the network
EU Innovation Network Membership
2
AT
FI
FR
PT
SE
BE
EU
HR
PL
UK
CZ
ES
HU
NO
DE (BfArM)
EE
IE
NL
DE (PEI)
DK
IT
MT
EU Innovation Network - Core profile within the network
Core profile within the network Target products Chemical medicines (90%)
The EU Innovation offices Network focuses on HUMAN health products.
Biological medicines (95%)
Vaccines (85%)
ATMPs (90%)
Innovation offices welcome a large variety of health products provided they contain some innovative features (scientific, technological or therapeutics)
Generic medicines (80%)
Biosimilar medicines (70%)
Combined/borderline (95%)
Medical devices are addressed in 50% of the offices and will be made soon eligible in one additional office. One office works also on cosmetics.
Medical devices (50%) Innovative methods and tools for drug development (70%)
3
EU Innovation Network - Core profile within the network
Core profile within the network Target products
Target groups
Chemical medicines (92%)
Academic research laboratories (100%)
Biological medicines (100%)
Hospital units (100%)
Vaccines (83%)
Start-ups (100%)
ATMPs (92%)
SMEs (100%)
Generic medicines (75%)
National/International groups (85%)
Biosimilar medicines (75%)
Consortia (65%)
Combined/borderline (92%)
Consulting groups (65%)
Medical devices (50%) Innovative methods and tools for drug development (75%)
4
EU Innovation Network - Core profile within the network
The services of the Innovation Support Offices are directed to hospitals, academic groups and SMEs, research foundations, consortia. Some have also expressed their willingness to hear from Patient interest groups and or funding/networking organisations.
Core profile within the network
5
Target products
Target groups
Focus
Chemical medicines (92%)
Academic research laboratories (100%)
Quality/viral safety (100%)
Biological medicines (100%)
Hospital units (100%)
Preclinical (100%)
Vaccines (83%)
Start-ups (100%%)
Clinical (100%)
ATMPs (92%)
SMEs (100%)
Production process (90%)
Generic medicines (75%)
National/International groups (100%)
Pharmacovigilance (80%)
Biosimilar medicines (75%)
Consortia (67%)
Help to make the redaction of documents (25%)
Combined/borderline (92%)
Consulting groups (67%)
Import / export (55%)
Medical devices (50%)
Regulatory processes (100%)
Innovative methods and tools for drug development (75%)
HTA/reimbursement – Payers (40%)
EU Innovation Network - Core profile within the network
The scope is wide and includes along the lifecycle of products manufacturing processes, redaction of documents, facilities, GMP, import/export issues, antimicrobials, biostatistics, preparations for scientific advice meetings, Pharmacovigilance, and HTA/Payers interactions
Core profile within the network
6
Target products
Target groups
Focus
Chemical medicines (90%)
Academic research laboratories (100%)
Quality/viral safety (100%)
Direct answer for simple questions (95%)
Biological medicines (95%)
Hospital units (100%)
Preclinical (100%)
Orientation towards the right competencies inside the Agency (90%)
Vaccines (85%)
Start-ups (100%%)
Clinical (100%)
Meeting for most innovative projects (70%)
ATMPs (90%)
SMEs (100%)
Production process (90%)
Diffusion of information via newsletter (15%)
Generic medicines (80%)
National/International groups (85%)
Pharmacovigilance (80%)
Diffusion of information via website (60%)
Biosimilar medicines (70%)
Consortia (65%)
Help to make the redaction of documents (25%)
Diffusion of information via organisation of meetings on specific topics (50%)
Combined/borderline (95%)
Consulting groups (65%)
Importation / exportation (55%)
Medical devices (50%)
Regulatory processes (100%)
Innovative methods and tools for drug development (70%)
Economic HTA/reimbursement – Payers (40%)
EU Innovation Network - Core profile within the network
Services
Diffusion of information via participation to meetings about health innovation (75%)
Identification of the core profile should allow the network to…
Ensure seamless support at national and EU level Prepare the EMRN for successful support to priority medicines
Develop EU methodology for innovation horizon scanning
Develop new ways to better communicate with target groups 7
EU Innovation Network - Core profile within the network
Encourage lifescience innovation for methods and tools for drug development
Identify challenging issues from emerging innovation
Identify best expertise
Develop training
Thank you for your attention Further information Heads of Medicines Agencies www.hma.eu European Medicines Agency www.ema.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 ...
Jun 22, 2016 - Information Management Division ... This document provides current information related to the volume and evaluation of .... Plasma master file.
Feb 9, 2017 - Notification of discontinuation of a paediatric development which is covered by an agreed ... for the following reason(s): (tick all that apply).
Jul 5, 2017 - Send a question via our website www.ema.europa.eu/contact ... non-proprietary names (INN) and therapeutic areas for all new ... also available in the monthly reports of the Committee for Orphan Medicinal Products (COMP).
Jul 4, 2016 - Send a question via our website www.ema.europa.eu/contact ... non-proprietary names (INN) and therapeutic areas for all new ... also available in the monthly reports of the Committee for Orphan Medicinal Products (COMP).
maximises the chances of a successful marketing authorisation. ... marketing authorisation. ⢠inclusion in the public SME ... E-mail [email protected]. Website ...
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.
5 days ago - Guidelines should include more details on the principles of good information design in which content and layout are ... relevance and importance of the QRD template is also acknowledged in this respect as it is the main tool .... databas
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 7, 2017 - Add an existing Tag to a specific Term . ...... This service creates an email body (text/html) of a user's notification data, a notification is based on.
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
Notification of discontinuation of a paediatric development which is covered by an agreed ... for the following reason(s): (tick all that apply). (possible) lack of ...
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
Jun 14, 2018 - Page 2/26. Product Name (in authorisation country). MRP/DCP Authorisation number. National Authorisation. Number. MAH of product in the.
Oct 26, 2017 - Injektionssuspension in einer Fertigspritze. Influenza-Impfstoff. (Spaltimpfstoff, inaktiviert, in Zellkulturen hergestellt) not available. BE393556. NANOTHERAPEUTICS. BOHUMIL, S.R.O.. BE. Preflucel injektionsvätska, suspension i för
March 2016 a joint database drug utilisation final study report to the European .... With regards to prescription of CPA/EE for contraceptive management, ...
For a list of RSS readers please refer to our RSS guide and follow the instructions ..... PCWP and HCPWP joint meeting: Workshop on social media - Sep 2016.