GetReal Institute
General Information
Identification Code: 829424448745-09
Website: [object Object]
Entity Form: Association
Registration Category: Other organisations, public or mixed entities
Registration Date: 2/6/2023
Last Update: 1/9/2024
EP Accredited Number: 0
Mission & Interests
Goals: Building on the Innovative Medicines Initiative’s GetReal and GetReal Initiative, the GetReal Institute is an independent, member-led not-for-profit organisation whose mission is to facilitate the adoption and implementation of Real-World Evidence in Regulatory, HTA and Clinical decision-making in Europe. We are committed to bringing together a diverse membership of public and commercial organisations to address critical challenges and opportunities relating to the generation, accessibility and use of Real-World Evidence.
Objectives that GetReal Institute is trying to achieve are:
1. Collaboration hub: Creating opportunities for collaboration with others organizations
2. Thought leadership: Developing new scientific methods that reduce uncertainties about the use of RWE
3. RWE Reference: Identifying and sharing resources that facilitate the understanding of RWE use
4. Interdisciplinary Understanding: Making knowledge sharing among stakeholders easier and more accessible
Interests Represented: Does not represent commercial interests
Interests:
- Digital economy and society
- Public health
- Research and innovation
Levels of Interest:
- european
- global
Activities
Main EU Legislative Proposals: GetReal activities are mainly focused on the following EU legislations:
1. The European Union (EU) legal framework for pharmaceuticals (Regulation (EC) No 726/2004)
2. Regulation on Health Technology Assessment – Regulation (EU) 2021/2282
3. Proposal for a regulation – The European Health Data Space (COM(2022) 197/2)
4. A pharmaceutical Strategy for Europe (COM(2020) 761 final)
Potentially GetReal Institute will focus on the following legislations as well:
5. Legislation around the use of the AI act
6. Data Act
The general focus of the GetReal Institute within these legislations is to look to examine the impact of this legislation on RWE decision making for the generation and use of RWE in order to support decision making by regulatory and HTA bodies. Furthermore, GetReal Institute is looking to assess how the legislations impact the abilities of commercial organisations (pharma and SME) and how patient interests are represented.
Communication Activities: Related to the European Medicines agency, GetReal provided a multistakeholder response to the consultation on the Data Quality Framework. GetReal plans to invite observer representation from the EMA to its Scientific Advisory Board.
Related to the EHDS: GetReal Institute has published a joint statement on the European Health Data Space on its website with over 30 organisations.
Furthermore, as the Institute is a relatively new organisation, we are in the process of planning how best to engage in the other policy areas.
Inter-institutional or Unofficial Groupings: N/A
Head Office
Address: Goeman Borgesiuslaan 77
Post Code: 3515 ET
City: Utrecht/ The Netherlands
Country: NETHERLANDS
Phone: [object Object]
EU Office
Address: Goeman Borgesiuslaan 77
Post Code: 3515 ET
City: Utrecht/ The Netherlands
Country: NETHERLANDS
Phone: [object Object]
Financial Data
New Organisation: false
Closed Year: [object Object]
Current Year: [object Object]
Membership Information
Members10 Percent: 2
Members25 Percent: 1
Members50 Percent: 1
Members75 Percent: 0
Members: 4
Members F T E: 0.949999988079071
Structure
Structure Type: Structure
Is Member Of: List of member organisations can be found on our website:
https://www.getreal-institute.org/about-us/members/
Organisation Members: N/A