Course offering number:1003-705
Course ID:
2379
GO BACK TO BROWSE ONLINE TRAINING COURSES PAGE
Tactics to an Effective FDA Submission
In Conjunction with Wiley-Blackwell
Pre-recorded Course
AN ON-DEMAND ONLINE TRAINING FORMAT
Who Should Attend
This online course is intended for professionals in the pharmaceutical, medical device and biologics industries. Personnel involved in the
submissions of NDAs, ANDAs, BLAs and PMAs will find this course valuable. The content will be especially beneficial to personnel within the
following categories:
• Business managers
• Executives
• Regulatory professionals
• VCs
Description
This 90-minute accredited training course provides a primer in the FDA submissions process for pharmaceutical, device, and biologics
companies.
If you are considering an NDA, ANDA, BLA, or 501(k)PMA here is the essential information you need to plan the process and maximize
success. An entire module of this course will be dedicated to a thorough explanation of the critical five steps needed to ensure a successful
FDA submission process.
Module 1: The Five Critical Steps:
• Planning
• Pre-submission meetings
• Submission for approval to conduct clinical tests
• Submission for drug/biologic/device
• Follow up
Module 2: IND and IDE Submissions:
• Submissions criteria
• The process
• Maximizing approval potential
Module 3: NDAs, ANDAs, PMAs, BLAs
• The process
• Maximizing approval potential
• Issues:
– labels
– post-marketing
Question and Answer Session