#30: Analysis of Safety Data from Clinical Trials

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

Day & Time:
June 23, 1:00PM - 4:30PM

Room Number:
160A

Registration Fees
- Standard Rate	$405.00

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

Juergen Kuebler, PhD
Global Head, Clinical Design, Analysis, and Reporting
CSL Behring GmbH, Germany

Description:
Maximize your learning while attending the DIA 2013 49th Annual Meeting! Receive $100 off of your DIA 2013 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.

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.

Event	Credit Type	Max Credits	CEU
#30: Analysis of Safety Data from Clinical Trials	ACPE CME IACET	3.25 3.25 3.25	0.325 0.000 0.300

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 regulatory affairs professionals, epidemiologists, drug safety professionals, medical affairs professionals, pharmacovigilance and quality management professionals, and clinical affairs professionals.