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Tutorial 04: ANALYSIS OF SAFETY DATA FROM CLINICAL TRIALS

Tutorial name:
Tutorial 04: ANALYSIS OF SAFETY DATA FROM CLINICAL TRIALS

Day & Time:
March 25, 9:00AM - 12:30PM (Central European Standard Time)

Room Number:
Room N

Registration Fees
- Standard Rate€400.00


Description:
The tutorial is a combination of theory, guidelines, practical considerations, and real-life solutions for those working in the clinical development environment (pharmaceutical, biotech industry, or CRO). The aim of this tutorial is to provide a basic understanding of the underlying methodology and the current guidelines on safety data. Aspects of the planning of clinical trials as well as the problems and pitfalls during the analysis of safety data will be presented. The presentations will also include case studies.

Learning Objective(s):
At the conclusion of this tutorial, participants should be able to: - Examine relevant guidelines and regulatory requirements for clinical trials - Recognize how to contribute to safety analysis plans - Assess statistical safety analysis and identify pitfalls in safety analysis - Recognize the impact of benefit-risk assessment in safety data

Target Audience:
This tutorial is designed for drug safety specialists, biostatisticians, medical writers, clinical researchers, project managers, and investigators.