Course offering number:0905-707
Course ID:
2271
Meeting Today’s FDA Requirements for Clinical Trial Processes
Pre-recorded Course
AN ON-DEMAND ONLINE TRAINING FORMAT
Who Should Attend
This course is designed for professionals within the pharmaceutical and biologics industries who are interested in the planning and submissions
of INDs. The training will be especially valuable to:
• Regulatory Personnel
• QA Managers
• Directors and VPs
• Representatives of Contract Research Organizations
(CROs)
Description
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
accredited 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.
Module 1: Overview: Clinical Testing
Concerns
• QbD
• Post marketing clinical testing
• Phases of Clinical Testing
Module 2: Steps
• Planning the Clinical Testing Process
• Pre-clinical
• IND filing
• Pre-meeting
• Design
• Research
• Investigator's Brochure
• IRB approval
• Format
Module 3: FDA Criteria and Concerns
• Foreign studies
• Design issues
• Safety and IRB review
• Study Size
• Blood/brain barrier
Question and Answer Session