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#40: Analysis of Safety Data from Clinical Trials

Tutorial name:
#40: Analysis of Safety Data from Clinical Trials

Day & Time:
June 15, 9:00AM - 5:00PM (Pacific Standard Time)

Room Number:
9

Registration Fees
- Standard Rate$755.00


Instructor(s):
Joachim Vollmar,
Executive Consultant
International Clinical Development Consultants LLC, United States

Jürgen Kübler, PhD
Head Quantitative Safety Sciences
CSL Behring GmbH, Germany

Description:
Maximize your learning while attending the DIA 2014 50th Annual Meeting! Receive $100 off of your DIA 2014 meeting registration by registering for two half-day tutorials or one full-day tutorial. Purchases must be made at the same time in order to receive the discount.

This 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 instructors, with the use of case study presentations, will 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.

EventCredit TypeMax CreditsCEU
#40: Analysis of Safety Data from Clinical Trials IACET
RN
ACPE
CME
6.50
6.50
6.50
6.50
0.700
0.000
0.650
0.000


Learning Objective(s):
At the conclusion of this tutorial, participants should be able to:
• Utilize guidelines and regulatory requirements for clinical trials;
• 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.