var _paq = window._paq = window._paq || []; /* tracker methods like "setCustomDimension" should be called before "trackPageView" */ _paq.push(['trackPageView']); _paq.push(['enableLinkTracking']); (function() { var u="https://rwrregs.matomo.cloud/"; _paq.push(['setTrackerUrl', u+'matomo.php']); _paq.push(['setSiteId', '1']); var d=document, g=d.createElement('script'), s=d.getElementsByTagName('script')[0]; g.async=true; g.data-privacy-src='//cdn.matomo.cloud/rwrregs.matomo.cloud/matomo.js'; s.parentNode.insertBefore(g,s); })();

SWEDEN | New TLV Rules Put Prevalence and Incidence Evidence at the Centre of Reimbursement Submissions

Please login to view this page.

SWEDEN | New TLV Rules Put Prevalence and Incidence Evidence at the Centre of Reimbursement Submissions2026-10-18T09:22:21+00:00

EU | Council Position on Pharma Package Broadens Post-Authorisation Study Powers and RWD Recognition

Please login to view this page.

EU | Council Position on Pharma Package Broadens Post-Authorisation Study Powers and RWD Recognition2026-10-18T09:17:29+00:00

EU | Revised GVP Module III Strengthens PV Oversight Across NIS, While Imposed-PASS Registration Becomes Legally Binding

Please login to view this page.

EU | Revised GVP Module III Strengthens PV Oversight Across NIS, While Imposed-PASS Registration Becomes Legally Binding2026-10-18T09:13:23+00:00

BRAZIL | INAEP Clarifies Single Ethics Review and AI Use in Human Research — Practical Implications for Multi-Centre NIS

Please login to view this page.

BRAZIL | INAEP Clarifies Single Ethics Review and AI Use in Human Research — Practical Implications for Multi-Centre NIS2026-10-18T09:07:37+00:00

USA | FDA Explores GenAI Medical Device Framework — RWD Could Shape Premarket and Postmarket Evidence

Please login to view this page.

USA | FDA Explores GenAI Medical Device Framework — RWD Could Shape Premarket and Postmarket Evidence2026-09-12T14:52:08+00:00

CANADA | CDA Sets Expectations for AI-Generated RWE — Human Oversight, Validation and Transparency Required

Please login to view this page.

CANADA | CDA Sets Expectations for AI-Generated RWE — Human Oversight, Validation and Transparency Required2026-09-12T11:47:27+00:00

USA | FDA Reissues Draft Guidance on Substantial Evidence of Effectiveness — Non-Interventional Studies Expressly Recognised Within the Adequate and Well-Controlled Investigation Framework

Please login to view this page.

USA | FDA Reissues Draft Guidance on Substantial Evidence of Effectiveness — Non-Interventional Studies Expressly Recognised Within the Adequate and Well-Controlled Investigation Framework2026-08-10T16:40:04+00:00

UK | HRA Updates Timeline for New Plan and Manage Health and Care Research Service (IRAS Replacement)

Please login to view this page.

UK | HRA Updates Timeline for New Plan and Manage Health and Care Research Service (IRAS Replacement)2026-08-10T16:35:19+00:00
Help

About Us

Contact Us

Our Values

SSO Login

Follow Us

LinkedIn

[…]

Legal Info

Privacy Policy

Terms and Conditions

Copyright 2026 | Real-World Research Limited | All Rights Reserved |

This website uses cookies and third party services. Settings
OK Reject

Cookies

We use analytical tools (Google Analytics) to help us improve the user experience. We DO NOT sell or use any of this data for any purpose beyond improving the design and usability of our own website (rwr-regs.com).
Go to Top