Generated by All in One SEO v4.9.10, this is an llms.txt file, used by LLMs to index the site. # Greg Testing, improving, and co-creating Guidance and Tools for Real World Evidence Generation and Use for Decision-Making in Europe ## Sitemaps - [XML Sitemap](https://ihi-greg.eu/sitemap.xml): Contains all public & indexable URLs for this website. ## Posts - [Meet the Work Package - WP3](https://ihi-greg.eu/news/meet-the-work-package-wp3/) - Led by NICE (UK) and co-led by Medtronic, WP3 collaborates with Health Technology Assessment (HTA) bodies, payers, and industry to bridge the gap between Real-World Data (RWD) and its application in HTA, improving decision-making for medicines, medical devices, and drug-device combinations across Europe. HTA bodies evaluate the clinical and economic value of health technologies, ensuring - [Meet the Work Package - WP2](https://ihi-greg.eu/news/meet-the-work-package-wp2/) - WP2 is where regulatory science meets real-world practice. Co-Led by the University of Oxford, University of Edinburgh and Bayer, this work package engages regulators and stakeholders to co-create evidence-based best practice recommendations as well as tools for using Real-World Data (RWD) and Real-World Evidence (RWE) in regulatory decision-making for medicines, medical devices, and drug-device combinations. - [Welcome to the 1st GREG Newsletter](https://ihi-greg.eu/newsletters/welcome-to-the-greg-newsletter/) - As coordinators of the GREG project, we are thrilled to share the first edition of the GREG Newsletter with you. These newsletters will be published bi-annually and provide regular updates including progress of the project, achievements and upcoming events. In addition, each issue will spotlight a key topic. We hope you enjoy reading this newsletter - [Welcome back for the 2nd GREG Newsletter](https://ihi-greg.eu/newsletters/welcome-back-for-the-2nd-greg-newsletter/) - The GREG Consortium together for the first General Assembly (GA) in Copenhagen, Denmark - May 2026 Welcome back to the GREG Newsletter! Having reached the first anniversary of project launch, we’d like to give you an update on progress, achievements and upcoming events. We’d also like to give you an insight into patient involvement in - [Meet the Work Package - WP1](https://ihi-greg.eu/news/meet-the-work-package-wp1/) - WP1 is the foundation of GREG, leading the co-creation of evidence-based practical guidance for the use of real-world data (RWD) and real-world evidence (RWE) in regulatory and health technology assessment (HTA) decision-making. Led by the Aragonese Institute of Health Sciences (IACS) and co-led by Novo Nordisk, this work package ensures that GREG’s outputs are scientifically - [IHI-GREG at the Patient Engagement Open Forum 2026](https://ihi-greg.eu/news/ihi-greg-at-the-patient-engagement-open-forum-2026/) - The IHI-GREG project is excited to present a session at the upcoming in-person Patient Engagement Open Forum (PEOF), focusing on Real-World Data (RWD) and Real-World Evidence (RWE). This interactive workshop-style session will explore how to bridge knowledge gaps, build capacity among stakeholders to enhance the uptake of RWE, and ensure meaningful patient involvement in these - [GREG Consortium Meeting 2026](https://ihi-greg.eu/news/greg-consortium-meeting-2026/) - Last week GREG held its annual Consortium Meeting in Copenhagen on 6–7th May 2026, bringing together partners from across the project to review progress, align on next steps, and strengthen collaboration. The meeting opened with an overview of achievements to date, including updates on use case selection and early lessons learned. Discussions highlighted the structured - [GREG presents at OHDSI Europe Symposium 2026](https://ihi-greg.eu/news/greg-presents-at-ohdsi-europe-symposium-2026/) - At the beginning of this week, GREG returned to Rotterdam for another international meeting, this time presenting at the OHDSI Europe Symposium 2026. This event brings together global leaders in health data science, Real-World Evidence (RWE), and open-source collaboration. It was an excellent opportunity to share insights, foster partnerships, and explore innovative approaches to improving patient outcomes. The EHDEN - [GREG Shines at DIA Europe 2026](https://ihi-greg.eu/news/greg-shines-at-dia-europe-2026/) - Daniel Prieto-Alhambra (Erasmus MC), Tara Srouji (Novo Nordisk), and Annika Jödicke (University of Oxford) GREG’s Project Coordinator, Daniel Prieto-Alhambra, and Academic Co-Lead Annika Jödicke, took the stage at DIA Europe 2026 to present the project’s groundbreaking approach to real-world evidence (RWE) generation—highlighting how GREG is bridging the gap between real-world data and regulatory decision-making. As - [First GREG HTA Expert Forum Meeting](https://ihi-greg.eu/news/first-greg-hta-expert-forum-meeting/) - The meeting included 14 HTA experts that assess Real-World Evidence (RWE) submissions, generate national RWE to inform local pricing and reimbursement decisions, or work at a policy level to support RWE developments in HTA. These experts from across Europe and Canada contributed expertise relating to the use of RWE to support HTA of medicines, devices - [Launch of the GREG Project](https://ihi-greg.eu/news/launch-of-the-greg-project/) - The GREG project has been officially launched to address persistent challenges in the generation, implementation, and acceptance of Real-World Evidence (RWE) for medicines, medical devices, and drug-device combinations in Europe. The GREG Initiative Will Tackle Persistent Challenges in Real-World Evidence While the interest and ability to use Real-World Data (RWD) sources to generate RWE have - [GREG at ESC Congress 2025](https://ihi-greg.eu/news/greg-at-esc-congress-2025/) - The GREG Consortium has taken part in the European Society of Cardiology (ESC) annual Congress, held in Madrid from August 29 to September 1, 2025. This event continues to be a cornerstone in the global cardiology calendar, bringing together thought leaders, clinicians, researchers, and regulators and policymakers from around the world to share knowledge, foster - [GREG Kick-Off Meeting in Rotterdam](https://ihi-greg.eu/news/greg-kick-off-meeting-in-rotterdam/) - The GREG project officially commenced with a two-day Kick-Off Meeting held in Rotterdam on 14–15 May, where around 80 participants from academia, industry, regulatory bodies, and patient organisations took part. Supported by the Innovative Health Initiative (IHI JU), GREG aims to co-create and deliver evidence-based guidance and tools to support the generation and use of ## Pages - [Home](https://ihi-greg.eu/) - Revolutionizing Real-World Evidence practices in EuropeRevolutionizing Real-World Evidence practices in EuropeGREG’s aimThe GREG project creates, tests, and shares practical, evidence-based guidance and tools to help generate and use Real-World Evidence (RWE). By improving how RWE informs the development and evaluation of medicines, medical devices, and drug-device combinations, GREG supports better decision-making for regulators and Health - [Project](https://ihi-greg.eu/project/) - ProjectGREG – “Testing, improving, and co-creating Guidance and Tools for Real World Evidence Generation and Use for Decision-Making in Europe”, is a 60-month initiative that began in May 2025, funded by the Innovative Health Initiative Joint Undertaking (IHI JU). The generation and use of Real-World Evidence (RWE) to inform the development and evaluation of medicines, - [News](https://ihi-greg.eu/news/) - AllNewsNewsletters July 15th, 2026Meet the Work Package – WP2WP2 – RWE for Regulatory Decision-Making WP2 is where regulatory science meets real-world practice. Co-Led by the University of Oxford, University of Edinburgh and Bayer, this work package engages regulators and stakeholders to co-create evidence-based best practice recommendations as well as tools for using Real-World Data (RWD) - [Knowledge](https://ihi-greg.eu/knowledge/) - PublicationsThe GREG publications are under development, and they will be published in this section when available.PodcastsThe GREG podcasts section is under development. We are working to bring you exciting podcasts.RWE use cases libraryIHI supports collaborative research projects and builds networks of industrial and academic experts in order to boost health research and innovation in Europe. - [Governance](https://ihi-greg.eu/governance/) - General Assembly The General Assembly is the governing body including representatives of all twenty-nine (29) partners. Executive Committee The Executive committee is a small operational group consisting of the Project Coordinator, the Project Leader the co-Project leader and the PMO. Its primary role is to ensure the smooth operation of the Action by aligning efforts - [Consortium](https://ihi-greg.eu/consortium/) - GREG’s communityThe GREG public-private partnership has unique multidisciplinary strengths and encompasses leaders from key RWE European initiatives, including academia, regulators, HTA agencies, non-governmental organisations (NGOs), project management experts, and industry leaders from the medicines, medical devices, and drug-device sectors. 0Public Partners0Industry PartnersGREG’s Public Partners GREG’s Private Partners - [Privacy Policy](https://ihi-greg.eu/privacy-policy/) - The present Privacy Policy describes the means and purposes of the processing of Personal Data through the website https://www.ihi-greg.eu/ (hereinafter called the “Website”). All content of the Website is owned or controlled by the Consortium of the GREG Project (hereinafter referred to as the “GREG Consortium” or the “Consortium”) and the terms and condition of - [Cookies Policy](https://ihi-greg.eu/cookies-policy/) - What are cookies and similar technologies? Cookies: Small text files sent from a website to your device, where they are stored by your web browser and later retrieved by the website. Tracking Technologies: Web Beacons, Pixels, Tags, Scripts and other technologies used for purposes similar to those intended by using cookies. E-mails and mobile applications - [Disclaimer](https://ihi-greg.eu/disclaimer/) - This project is supported by the Innovative Health Initiative Joint Undertaking (IHI JU) under grant agreement No 101191967. The JU receives support from the European Union’s Horizon Europe research and innovation programme and COCIR, EFPIA, Europa Bío, MedTech Europe, and Vaccines Europe and Instem Scientific Limited. Funded by the European Union, the private members, and - [About IHI](https://ihi-greg.eu/about-ihi/) - The Innovative Health Initiative (IHI) aims to translate health research and innovation into real benefits for patients and society, and ensure that Europe remains at the cutting edge of interdisciplinary, sustainable, patient-centric health research. Health research and care increasingly involve diverse sectors. By supporting projects that bring these sectors together, IHI will pave the way ## Deliverables - [D1.3 Early report on RWE methodological challenges (1)](https://ihi-greg.eu/deliverable/d1-3-early-report-on-rwe-methodological-challenges-1/) - [D1.2 Early report on RWE needs (1)](https://ihi-greg.eu/deliverable/d1-2-early-report-on-rwe-needs-1/) - [D2.1 Regulatory Stakeholder Forum](https://ihi-greg.eu/deliverable/d2-1-regulatory-stakeholder-forum/) - [D6.2 Data Landscaping Reports](https://ihi-greg.eu/deliverable/d6-2-data-landscaping-reports/) - [D4.1 Observational studies protocol](https://ihi-greg.eu/deliverable/d4-1-observational-studies-protocol/) - [D3.1 HTA Expert Forum](https://ihi-greg.eu/deliverable/d3-1-hta-expert-forum/) - [D8.1 Dissemination and Communication Plan](https://ihi-greg.eu/deliverable/d8-1-dissemination-and-communication-plan/) - [D7.1 PAG Detailed Composition](https://ihi-greg.eu/deliverable/deliverable-2/) - [D1.1 Early report based on systemic review](https://ihi-greg.eu/deliverable/deliverable-1/) ## Partners - [EHDEN Foundation](https://ihi-greg.eu/partner/ehden-foundation/) - [Amgen](https://ihi-greg.eu/partner/amgen/) - [GSK](https://ihi-greg.eu/partner/gsk/) - [Janssen-Cilag](https://ihi-greg.eu/partner/janssen-cilag/) - [Boheringer Ingelheim](https://ihi-greg.eu/partner/boheringer-ingelheim/) - [Bristol Myers Squibb](https://ihi-greg.eu/partner/bristol-myers-squibb/) - [GORE](https://ihi-greg.eu/partner/gore/) - [Pfizer](https://ihi-greg.eu/partner/pfizer/) - [Servier](https://ihi-greg.eu/partner/servier/) - [Mölnlycke](https://ihi-greg.eu/partner/molnlycke/) - [Medtronic](https://ihi-greg.eu/partner/medtronic/) - [Edwards Lifesciences](https://ihi-greg.eu/partner/edwards-lifesciences/) - [Bayer](https://ihi-greg.eu/partner/bayer/) - [Sanofi](https://ihi-greg.eu/partner/sanofi/) - [Novo Nordisk](https://ihi-greg.eu/partner/novo-nordisk/) - [Norwegian Medicines Agency](https://ihi-greg.eu/partner/norwegian-medicines-agency/) - [Universidade de Aveiro](https://ihi-greg.eu/partner/universidade-de-aveiro/) - [University of Dundee](https://ihi-greg.eu/partner/university-of-dundee/) - [The Hyve](https://ihi-greg.eu/partner/the-hyve/) - [University of Galway](https://ihi-greg.eu/partner/university-of-galway/) - [Instituto Aragonés de Ciencias de la Salud](https://ihi-greg.eu/partner/instituto-aragones-de-ciencias-de-la-salud/) - [EUPATI Foundation](https://ihi-greg.eu/partner/eupati-foundation/) - [Erasmus University Rotterdam](https://ihi-greg.eu/partner/erasmus-university-rotterdam/) - [European Society of Cardiology](https://ihi-greg.eu/partner/european-society-of-cardiology/) - [GetReal Institute](https://ihi-greg.eu/partner/getreal-institute/) - [National Institute for Health and Care Excellence](https://ihi-greg.eu/partner/national-institute-for-health-and-care-excellence/) - [SYNAPSE Research Management Partners](https://ihi-greg.eu/partner/synapse-research-management-partners/) - [University of Oxford](https://ihi-greg.eu/partner/university-of-oxford/) - [Erasmus University Medical Center](https://ihi-greg.eu/partner/erasmus-university-medical-center/) ## Categories - [News](https://ihi-greg.eu/category/news/) - [Newsletters](https://ihi-greg.eu/category/newsletters/) ## Partners - [Public](https://ihi-greg.eu/partner/public/) - [Private](https://ihi-greg.eu/partner/private/)