1st DIA India’s Cardiac safety Conference


Date(s) And Time(s):
Mar 12 2011 8:00AM - Mar 12 2011 5:00PM

Hotel Westin
International Business Park, Oberoli Garden City
Goregaon East
Mumbai 400063


Cardiovascular toxicity and adverse eff ects are the leading reasons why
pharmaceuticals are stopped during development and why approved
pharmaceuticals are withdrawn from the market. Several high profi le
withdrawals in recent years have triggered public concerns and heightened
regulatory focus and scrutiny on cardiac safety of pharmaceuticals
under development—making cardiac safety a top priority for pharmaceutical
companies. This meeting will discuss guidelines and best practices
for both QT and non-QT-related cardiac safety issues, including the
IC4-E-14 Guidance and the FDA Guidance on Evaluating Cardiovascular
Risk for New Anti-diabetic Drugs.

• Basic Concepts Related to the Collection, Analysis, Quality Control and
Interpretation of ECG Data
• Design, Conduct, Analysis and Interpretation of a Thorough QT/QTC Study
• QT Assessment of Oncology and Biological Pharmaceutical Products
• Innovative Approaches to Assessing QT Prolongation
• Cardiovascular Safety beyond the QT Interval

Target Audience:
Professionals, researchers and clinicians, including:
• Drug development and clinical research managers and associates
• Pharmaceutical physicians and medical directors
• Safety pharmacology and nonclinical scientists
• Drug safety and drug surveillance personnel
• Clinical pharmacology scientists
• Pharmacology managers
• Regulatory aff airs managers
• Biostatisticians
• Data managers
• IT/Technology managers
• Outsourcing and marketing managers
• ECG lab and equipment vendors
• Academic scientists and cardiologists

Event Code:

Manoj Trivedi, Senior Consultant, Marketing & Program Development, DIA
(India) Private Limited; Cell: +91-9819777493
Fax: +91-22-2859-4762,
Email: Manoj.Trivedi@diaindia.org