“Oops, I made a mistake!” Mistakes can happen – surely everyone has made or seen one. But how can you avoid mistakes in your next submission?
This webinar will examine common administrative and technical mistakes, errors, and omissions in regulatory submissions and how to avoid and/or solve them. We’ll share tips, ideas, and solutions to avoid a less than ideal mistake.
A few examples of what we will cover: what if you incorrectly filled out an FDA form, or forgot to include one in your submission? What if you made an eCTD lifecycle or relationship blooper? What if you transmitted a submission to the wrong place?
We will look at one prevention tool, a checklist, which can be tailored to a particular region/health authority and the unique type of submission. Some nuances between certain authorities will also be touched upon, such as US FDA, Health Canada, and EMA. Avoid the dread of worrying about what to do if something goes amiss, with these positive ideas on what to do and how to do it.
Learning Objectives
- Recognize common electronic submission mistakes, errors, and omissions.
- Identify techniques, tools, and practices for avoiding electronic submission mistakes.
- Summarize options of what to do if you make or notice a mistake.
Presented by: Rachel Bombara, Regulatory Services Manager, Certara