European Statistical Meeting on Analysis of Safety Data in Clinical Trials

Friday 23^rd June 2017

Venue: Astellas Pharma Europe B.V., Sylviusweg 62, 2333BE Leiden, Netherlands

Safety data are the most common and one of the most important type of data collected in clinical trials. However, in general, the emphasis is on the efficacy data. In this meeting, we will take a look at various aspects of safety data in a clinical trial. Colleagues from industry, academia and regulatory agencies will come together to discuss latest developments for statistical analysis of adverse events, current practices in the conduct of data monitoring committees, and related topics on safety data in clinical trials. We will also hear thoughts on personalized safety analyses.

Presentations

1. EFSPI-PSDM - Safety Data Analysis - Final Agenda

2. About EFSPI

3. Personalised Drug Safety

4. EMA Guidance for FiH Studies

5. An Insider's View on Data Monitoring Committees

6. Decision Criteria for IDMC's - Perspectives on current challenges

7. Analyzing Recurrent Adverse Events from RCTs

8. Bayesian Joint Modelling of Benefit and Risk in Drug Development

9. Using Risk Indicators for Visualizing High-Dimensional Safety Data

10. How to make adverse events look pretty