A Process for Evaluating Quality Decision-Making Practices During the Development, Review and Reimbursement of Medicines.

ABSTRACT:

Background

The development of a medicine is not only underpinned by good science but also by Quality DecisionMaking Practices (QDMPs). Indeed, it is important to ensure that all organisations involved in the lifecycle of medicines are aligning their practices in decision-making to the QDMPs to ensure quality, transparent and consistent decisionmaking processes.

Methods

The aim of this study was to evaluate the practicality of QoDoS (Quality of Decision-Making Orientation Scheme) in assessing the incorporation of ten QDMPs during the development, review and reimbursement of medicines, illustrated by case studies with a pharmaceutical company, a regulatory authority and a health technology assessment (HTA) agency. Individuals from each organisation completed the 47-item QoDoS

SUBMITTER: Bujar M 

PROVIDER: S-EPMC9278608 | biostudies-literature | 2022 Feb

REPOSITORIES: biostudies-literature