OBJECTIVES

This course is an advanced training with focus on quantitative aspects and modern statistics applied to pharmacoepidemiological studies aimed at hypothesis testing. You are required to know how to use basic regression models to follow this training.

At the end of this course, you will

1. Understand how data on adverse drug events derived from analysis of individual patients can lead to inferences regarding populations
2. Know the various study designs in pharmacoepidemiology and to determine which study design is appropriate to address specific safety issues
3. Be familiar with basic statistical concepts and techniques as applied to pharmacoepidemiology
4. Understand and assist in pharmacoepidemiological studies using large healthcare databases
5. Understand the process of risk communication from the point of view of different stakeholders

ADRs, AEs, causality, observational databases, study design, confounding, meta-analysis, bayesian methods

MODULE PARTS

1. Introduction: from case based reasoning to population based reasoning
2. Designing a study: study designs, basic epidemiological measures, data sources, workflow to quantify risks, case and exposure identification, codes of conduct, writing a protocol
3. Designing a study II: Causality from different perspectives, Causal diagrams, and Building a Statistical Analysis Plan
4. Raw Data to Metrics: Elementary and advanced analysis methods with an introduction to data analysis in R
5. Communication of results: communication with academia, regulators, pharmaceutical industry, writing a pharmacoepidemiological paper

TRAINER TEAM

Coordinator: Prof Miriam Sturkenboom (from University Medical Center Utrecht)

Expert(s): Prof Nicholas Moore (from Université de Bordeaux), Dr Martijn Schuemie (from Janssen Pharmaceutica NV), Dr Katia Verhamme (from Erasmus Universitair Medisch Centrum), Dirk Teuwen (from UCB Pharma SA), Noah Jamie Robinson, Dr George Quartey, Dr Preciosa Coloma, Dr Philippe Van Der Auwera, Dr Bharat Thakrar (from F. Hoffmann-La Roche Ltd), Dr Gianluca Trifiro (from Università degli studi di Messina), Dr Sabine Straus (from Dutch Medicines evaluation Board), Dr Silvana Romio, Dr Caitlin Dodd, Vjola Hoxhaj, Dr Fariba Ahmadizar, Carlos Duran, Maryam Hosseini Ryvandi (from University Medical Center Utrecht), Dr Hans Petri (from Petri Consulting Ltd).