The Center for Professional Advancement (CfPA) has a pre-recorded course available for on-demand online training titled “Meeting Today’s FDA Requirements for Clinical Trial Processes.”
Information from the CfPA website describes the course as being “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 from CfPA:
“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
For more information about this course and others offered by CfPA, please visit their website.
