Danish Agency Claims A First In Raw Data Analysis
Executive Summary
The Danish Medicines Agency says it is about time that EU regulators developed US FDA-style capabilities to analyze raw data so that they can make better use of the opportunities provided by big data. Agency chief Thomas Senderovitz tells Medtech Insight how Denmark is setting up a unique data analytics center for medical devices and drugs without reinventing the wheel.
You may also be interested in...
Denmark Leads New EU Task Force Exploring Use Of Big Data In Medicines Assessment
EU drug regulators have created a new task force to establish a roadmap and recommendations on how to use big data in the assessment of medicines.
EU Consults On What Constitutes Personal & Commercially Confidential Data In Marketing Applications
Based on their experience with dealing with requests for access to documents over the past 12 years, EU regulators have proposed updating their guideline that provides for a harmonized approach to protecting personal data and business secrets in marketing authorization applications.
Global Pharma Guidance Tracker – March 2024
Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.