News

Christa Wirthumer-Hoche, PhD, head of the Austrian Medicines and Medical Devices Agency, has been elected Vice-Chair of the European Medicines Agency (EMA) by the Management Board for a three-year period.

Whether we are referring to CSRs or to IPD, the personal information of trial participants needs to be de-identified prior to release. This article will describe the available methods for de-identifying clinical trial data, and the relative strengths and weaknesses of each.

To celebrate 20 years since its opening, the European Medicines Agency (EMA) organized a one-day meeting this week. Called “Science, Medicines, Health: Patients at the heart of future innovation”, the invitation-only event in London focused on the EMA’s future role

SA3.png

 Sentiment analysis can give health care organizations a competitive edge in understanding what customers think about their healthcare experience, to help reduce costs and improve care service and to lead to new clinical research and treatments. In addition, it taps into a new channel of pharmacovigilance input information that can enable Marketing Authorization Holders to keep abreast of opinions on the safety of their products in real time.

Over the years, clinical study management has become more fragmented. There are more organizations participating in a study, each bringing their own experiences, interpretations of requirements including how quality is defined. How is it possible that requirements and quality be interpreted so differently?