Efforts Build For Global Approach To Patient-Focused Drug Development
Executive Summary
The International Council for Harmonisation wants to ensure that methods used to collect and integrate patient views into drug development and regulatory decision-making follow agreed standards.
You may also be interested in...
EMA Presses On With Keenly-Awaited Guidance On How To Use Patient Experience Data
While the International Council of Harmonisation is developing a harmonized approach to patient-focused drug development, the European Medicines Agency has heeded calls for “prompt guidance” to support the systematic inclusion of patient experience data in regulatory submissions.
ICH Plans New Guideline On Pharmacoepidemiological Studies Using RWD
At its latest meeting in June, the International Council for Harmonisation agreed on new topics that could benefit from harmonized advice and took note of progress made on drafting and finalizing quality, safety and multidisciplinary guidelines.
EU Framework For Patient Preference Studies Under Review
An EU public-private collaborative project is seeking validation from regulators and health technology assessment bodies regarding its proposed best practice approach to conducting patient preference studies.