Clinical Testing Process Training Course :

<strong>Course Schedule - February 5, 2009 at 11:00 a.m. - 12:30 p.m. (EST)</strong><br/><br/>The FDA procedures for the clinical testing of drugs, potentially leading to the filing of an NDA or ANDA, are evolving rapidly. This 90-minute <b><i>accredited</b></i> program examines the steps involved in designing and filing for permission to conduct the clinical tests (the IND); and the FDA issues and concerns in reviewing IND applications.<br><br> <b><u>Module 1:</u> Overview: Clinical testing concerns</b><br>   • QbD<br>   • Post marketing clinical testing<br>   • Phases of Clinical Testing<br><br> <b><u>Module 2:</u> Steps</b><br>   • Planning the Clinical Testing Process<br>   • Pre-clinical<br>   • IND filing<br>   • Pre-meeting<br>   • Design<br>   • Research<br>   • Investigator's Brochure<br>   • IRB approval<br>   • Format<br><br> <b><u>Module 3:</u> FDA Criteria and Concerns</b><br>   • Foreign studies<br>   • Design issues<br>   • Safety and IRB review<br>   • Study Size<br>   • Blood/brain barrier<br><br> <b>Question and Answer Session</b>