Overview

Analyses of observational data have played a central role in assessing post authorisation drug safety for many years. However, systematic collection of clinical practice records in electronic form has increased the range and quality of possible analyses and the use of such data in other areas of clinical research. This raises important questions for those designing and conducting both pre- and post-approval research and those attempting to base regulatory decisions on the results.

Registration fees for this Information Day

Standard : € 600.00

Academia/Charitable/Government/Non-Profit (full time): € 300.00

What you will learn

• How to select the most reliable methods from the diverse range of study designs used in observational analyses

• Which types of questions can be addressed using observational data alone and which require interventional techniques and, in particular, randomisation of alternative treatments

• How the observational data can best be used to enhance and extend the current methods used in clinical research

Follow-up through routine clinical data collection
Value of additional non-randomised control data: concurrent or historical

• 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

Who should attend?

Statisticians and researchers involved in drug research based on observational data such as Real-World Data Specialists, Statisticians in R&D, Epidemiologists, and PRAC members

Program Committee

Sigrid Behr, PhD Group Head Quantitative Safety & Epidemiology
Novartis Pharma AG, Switzerland
Hans Ulrich Burger, PhD Senior Director of Biostatistics
F. Hoffmann-La Roche Ltd., Switzerland
Stephen JW Evans, MSc, FRCP Professor of Pharmacoepidemiology
The London School of Hygiene & Tropical Medicine, United Kingdom
Jürgen Kübler, PhD Owner
Quantitative Scientific Consulting, Germany
Jim Slattery, MSc Statistician, Pharmacovigilance Department
European Medicines Agency, Netherlands
Andrew Thomson, PhD, MA, MS Statistician, Methodology Taskforce
European Medicines Agency, Netherlands
Richardus J Vonk Head of Research and Clinical Sciences Statistics
Bayer AG, Germany

Have an account?

EMA/DIA EU Statistics Forum

Overview

What you will learn

Who should attend?

Program Committee

Be informed and stay engaged.