The US Food and Drug Administration-European Medicines Agency Collaboration in Pharmacovigilance: Common Objectives and Common Challenges

Abstract On 19 February 2014, the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) announced the formation of a cluster on pharmacovigilance topics. The cluster is designed to complement, and not replace, other international activities in this field. It builds upon years of interactions between the two agencies. The creation of the cluster formalizes this longstanding and productive relationship and facilitates more systematic exchange of information and expertise

Clock-Drawing in Neurological Disorders

Clock-drawing is a widely used bedside test of constructional ability, but it has never been systematically studied or standardized. We examined 87 clocks drawn by neurologically impaired patients and age-matched controls, and propose a set of criteria for scoring clocks. Patients with probable Alzheimer's disease and other dementias have gross impairments in clock-drawing. These deficits include poor spatial arrangement of numbers, incorrect numerical sequence, insertion of stray lines, and addition of extra numbers. In Alzheimer's disease, the total score on the clock-drawing test correlates with the score on the Modified “Mini-Mental State” Examination. Non-demented patients with Parkinson's disease showed only defects in the spatial organization of the numbers, and non-demented patients with other diseases perform as well as controls

Clock-Drawing in Neurological Disorders

Clock-drawing is a widely used bedside test of constructional ability, but it has never been systematically studied or standardized. We examined 87 clocks drawn by neurologically impaired patients and age-matched controls, and propose a set of criteria for scoring clocks. Patients with probable Alzheimer's disease and other dementias have gross impairments in clock-drawing. These deficits include poor spatial arrangement of numbers, incorrect numerical sequence, insertion of stray lines, and addition of extra numbers. In Alzheimer's disease, the total score on the clock-drawing test correlates with the score on the Modified “Mini-Mental State” Examination. Non-demented patients with Parkinson's disease showed only defects in the spatial organization of the numbers, and non-demented patients with other diseases perform as well as controls

Orphan Therapies: Making Best Use of Postmarket Data

Postmarket surveillance of the comparative safety and efficacy of orphan therapeutics is challenging, particularly when multiple therapeutics are licensed for the same orphan indication. To make best use of product-specific registry data collected to fulfill regulatory requirements, we propose the creation of a distributed electronic health data network among registries. Such a network could support sequential statistical analyses designed to detect early warnings of excess risks. We use a simulated example to explore the circumstances under which a distributed network may prove advantageous

Data driven regulatory science

Background: Drug regulatory science closely relates to pharmacoepidemiology, particularly where epidemiologic methods are used to derive empirical evidence on the outcomes and implications of drug regulation. Objectives: In this symposium, we will present the results from recent regulatory science studies on the functioning of post-marketing surveillance systems. Description: After a short introduction of the scientific field and methods applied to evaluate pharmacovigilance systems, results from four recently performed studies will be presented. The studies cover different aspects from the pharmacovigilance system in different continents: (1) Predictors of successful pharmacovigilance systems in Africa: determinants of ADR reporting in African countries (Hilda Ampadu) (2) FDAAA mandated 18 months, 10 000 patient reviews: experiences with the first cohort of newly approved products in the USA since 2007 (Shohko Sekine) (3) Characteristics and follow-up of post-marketing obligations of medicinal products with a conditional marketing authorization in Europe, 2006- 2014 (Jarno Hoekman) (4) The role of registries in European post-marketing surveillance, a retrospective analysis of centrally approved products, 2005-2013 (Xavier Kurz) A multidisciplinary panel will provide their views and results of the studies. Implications for policy and further research will be discussed with panelists and the broader audience. Three different angles of focus will be chosen. The academic perspective: What are the implications for data collection and methodologies? The regulatory perspective: What are the implications for design and enforcement of post-marketing obligations? The pharmacovigilance perspective: What are the implications for how to organize to post-marketing surveillance in practice