Institute for International Research

When: 05-December-07, 11:00 A.M. – 12:00 P.M.
Time Zone: Eastern Standard Time (US and Canada)
Cost: FREE - Online Registration is OPEN

WEB SEMINAR DESCRIPTION: 

Given the potential lethality of cardiac adverse drug reactions, assessment of a drug's cardiac safety profile is of particular importance.  Two areas to be discussed in this webinar are a drug molecule's propensity to elicit certain ventricular arrhythmias and the occurrence of other cardiac adverse drug reactions, such as fatal and non-fatal myocardial infarctions, non-fatal debilitating conditions, and various pathophysiological characteristics that increase the likelihood of cardiac events.

• Realization that comprehensive cardiac safety assessment requires an integrated approach that makes full use of optimum quality information to make benefit-risk assessments throughout a drug's lifecycle.  
• The in silico structure-function prediction research conducted during contemporary drug design.  
• The role of ICH Guidance S7B, Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals, in directing nonclinical cardiac safety research addressing an investigational drug's proarrhythmic liability.
• Postmarketing surveillance methodologies, and their role in monitoring for the occurrence of proarrhythmic and other cardiac adverse drug reactions.
  

Speaker:
J. Rick Turner, PhD, Chairman, Department of Clinical Research
Campbell University School of Pharmacy

 
Facilitator:

J. Rick Turner, PhD
Chairman, Department of Clinical Research
Campbell University School of Pharmacy

AND

Consulting Executive Director of Operations
Clinical Trials Management Group, Inc.

Dr Turner has 9 years of experience in the pharmaceutical industry, working most recently as a Clinical Submissions Scientist at GlaxoSmithKline.  He has extensive experience writing regulatory documents for manufacturing processes and clinical research studies, and continues to provide consulting services to pharmaceutical services and contract research organizations.

 Dr Turner is the Chairman of the Department of Clinical Research at the Campbell University School of Pharmacy, and his department offers Bachelor and Master of Science degree programs in Clinical Research.  He is the author and editor of 10 books.  His most recently published book, New Drug Development: Design, Methodology, and Analysis (John Wiley & Sons, 2007), provides a comprehensive overview of the process of new drug development, integrating discussions of drug discovery, manufacturing, nonclinical research, preapproval clinical trials, and postmarketing surveillance.  He is currently completing work on a book on drug cardiac safety (again for John Wiley & Sons).

Dr Turner is also Consulting Executive Director of Operations for Clinical Trials Management Group, Inc. (CTMG).  CTMG provides unique quality control systems management, operational expertise, and support personnel to enable physician Principal Investigators in busy practices to effectively conduct clinical trials while fulfilling all regular patient care responsibilities.

The Department of Clinical Research is one of three departments in the Campbell University School of Pharmacy.  The School offers a PharmD degree, and also offers Bachelor and Master of Science degrees in Clinical Research and in Pharmaceutical Sciences.
http://www.campbell.edu/pharmacy/programs/index.html

Clinical Trials Management Group, Inc. (CTMG) provides unique quality control systems management, operational expertise, and support personnel to enable physician Principal Investigators in busy practices to effectively conduct clinical trials while fulfilling all regular patient care responsibilities. http://www.ctmginc.com

AND

Consulting Executive Director of Operations
Clinical Trials Management Group, Inc.