In July and August 2014, the European Medicines Agency (EMA) organised two public consultations concerning European pharmacovigilance. These two consultations reveal a number of EMA proposals that are counterproductive to the objective of improving transparency over pharmacovigilance data. The EMA's proposals offer pharmaceutical companies an opportunity to participate in public hearings held b...

The paper investigates the relation between the parameters of an autoregressive moving average (ARMA) model and its equivalent moving average (EMA) model. On the basis of this relation, a new method is proposed for determining the ARMA model parameters from the coefficients of a finite-order EMA model. This method is a three-step approach: in the first step, a simple recursion relating the EMA ...

LETTERS Invasive or non-invasive methods for the diagnosis of subclinical coeliac disease? I read with great interest the letters published in Gut on the role of small bowel biopsies and antiendomysial antibodies (EMA) as methods for diagnosing coeliac disease in patients with iron deficiency anaemia (IDA) (Gut 2001;49:595). In particular, Pearce et al seem to prefer EMA instead of histological...

The increasing pace of investments across academia and industry in the areas of pharmacometrics and systems pharmacology has the potential to profoundly impact drug discovery and development efficiency. In addition, it is being recognized that model-based approaches have also increasingly become important in regulatory decision making.1–3 For example, an analysis of 198 new drug application and...

OBJECTIVE The purpose of this study was to explore whether the presence of thyroid and endomysial autoantibodies at diagnosis of type 1 diabetes in children predicts development of thyroid and celiac disease, respectively, and whether diabetes-associated autoantibodies at diagnosis predict development of microvascular complications up to 13 years later. RESEARCH DESIGN AND METHODS Autoantibod...

With the implementation of Article 57(2) in 2012 the European Medicines Agency (EMA) embarked on a digitalization journey that foreseeably would ensure greater product oversight and interoperability across the community. This initiative has subsequently led to additional focus from the agency with respect to the utilization and harmonization of data as part of the regulatory process. Driven by ...