Regulatory and health technology assessment advice on postlicensing and postlaunch evidence generation is a foundation for lifecycle data collection for medicines.

The understanding of the benefit risk profile, and relative effectiveness of a new medicinal product, are initially established in a circumscribed patient population through clinical trials. There may be uncertainties associated with the new medicinal product that cannot be, or do not need to be resolved before launch. Postlicensing or postlaunch evidence generation (PLEG) is a term for evidence generated after the licensure or launch of a medicinal product to address these remaining uncertainties.

Prevalence of undiagnosed atrial fibrillation and of that not being treated with anticoagulant drugs: the AFABE study.

Introduction And Objectives: Atrial fibrillation constitutes a serious public health problem because it can lead to complications. Thus, the management of this arrhythmia must include not only its treatment, but antithrombotic therapy as well. The main goal is to determine the proportion of cases of undiagnosed atrial fibrillation and the proportion of patients not being treated with oral anticoagulants.

[The management of atrial fibrillation and characteristics of its current care in outpatients. AFABE observational study].

Aim: To provide insights into the characteristics and management of outpatients when their atrial fibrillation (AF) was first detected: diagnosis, treatment and follow-up in the context of the public health system.

Design: AFABE is an observational, multicentre descriptive study with retrospective data collection relating to the practice patterns, management and initial strategies of treatment of patients with diagnosed AF in the context of primary care, emergency and cardiologists of the public health system.

Setting: Primary and Specialist care.