Course offering number:0903-705
Course ID:
2272
Clinical Testing Submissions
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 dealing with the FDA Pre-IND meeting and the procedures for electronic IND filing. Quality
issues within the clinical arena will be addressed. Attention will be directed toward developing a plan for the pre-IND meeting and industry and
FDA guidelines for electronic INDs.
Dealing with the FDA Pre-IND Meeting and Details of Electronic Filings
Module 1: Quality Issues in Clinical
• Clinical Team pre-IND meeting with FDA
• Focusing on the important issues and meta-issues
• Evaluating research facilities and strategies
• Ethical issues
• Protection of the safety, rights of persons participating
Module 2: Prep for the Pre-IND Meeting
• Early interactions with FDA staff to help to prevent clinical
issues from arising
• Selection of appropriate CROs and Investigators
• The Mock-Meeting: managing expectations
• Efficient use of FDA resources
Module 3: Electronic INDs
• Evolving process
• Industry guidance and FDA guidelines
• e-Forms
• Alternatives: paper, paper with electronic index, paper with
hyperlinks
Question and Answer Session