Submitted by: Submitted by ShrikantM
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Category: Business and Industry
Date Submitted: 12/02/2015 10:50 PM
Researchmoz added Most up-to-date research on "Adaptive Licensing - A Holistic Approach to Drug Development and Regulation" to its huge collection of research reports.
Adaptive Licensing (AL) is a flexible approach to drug development and regulation, with two live pilot schemes accepted by the European Medicines Agency (EMA). The system acknowledges that levels of uncertainty will always surround innovative treatments. An initial license is granted at an earlier stage than possible under the traditional system, with less clinical information from Randomized Controlled Trials (RCTs). After the initial license is granted, the entry to market is heavily restricted, and the patient population is carefully monitored through observational studies, electronic devices and registries. Data from ongoing RCTs, and the more robust data from post-license surveillance studies are used to determine full license permission. By improving the alignment of stakeholder needs in a fluid system, overall costs and patient access times can be reduced. However, uncertainty still exists around the approach, and it is clear that cultural and political changes will be necessary to realize the full potential of AL.
Browse Detail Report With TOC @ http://www.researchmoz.us/adaptive-licensing-a-holistic-approach-to-drug-development-and-regulation-report.html
Scope
Adaptive Licensing: Overview
Introduction
A Declining Industry – How AL can tackle issues with the current system
Strengths
Challenges for AL
Proponents
Current Adaptive Licensing
Precursors – Current systems within the traditional drug licensing framework that will act as facilitators to AL
Legality – Feasibility of AL across different jurisdictions
Employing Adaptive Licensing – EMA pilot scheme information, practical strategies
Future Adaptive Licensing
Transformative Strategies – Future utility of AL requiring legislative change
Commercial Considerations...