Description
<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>
01/13/2009
To
01/01/0001
Training Company
The Center for Professional Advancement (CfPA)
Industry
Clinical Research Organization
Course Category
Brochure Name
http://www.cfpa.com/PDF/2009/2271,C8-338,0902-102.pdf
Address
90 Minute Accredited Online Training Online Training