News and events

2017-12-01 - 2017-12-01 : EMA

European Medicines Agency (EMA) / Drug Information Association (DIA) statistics forum: The role of observational data in assessing the benefits and risks of medicines

This forum considers the place of observational research in the clinical evaluation of medicines and seeks views on how to select promising study designs, prospectively specify objective criteria for evaluation of study results and define procedures to ensure the reliability of results. The overall aim is to contribute to the ongoing debate on how to assess research based on observational studies and in particular, how to pre-specify criteria of ‘success’ in an observational study in a way that would allow confident design of a research programme to meet regulatory requirements. These discussions will address the lack of regulatory guidance in this area, which was highlighted by moves to extend the use of epidemiological analyses (previously used primarily for prospective clinical trials) into areas of medicine development due to the increasing availability of more and higher quality observational data.

2017-11-30 - 2017-12-01 : EMA

Data anonymisation workshop

The data anonymisation workshop focuses on anonymisation as a key enabler for clinical data sharing. The scope of the workshop includes clinical trial data including individual patient level data and real world data in the context of patient registries and individual cohort studies.