Sponsored Webcast: Oops, I Messed Up! How to Avoid (and Fix) Common Regulatory Submission Mistakes (On-demand)

Oops, I made a mistake! Everyone has made or seen one, and sometimes it is embarrassing to discuss. This webcast will examine common administrative and technical mistakes, errors, and omissions in regulatory submissions and how to avoid and/or solve them. Hints, ideas, and solutions will be shared to avoid or avert doing something less than ideal. 

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 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 wondering or worrying about what to do if something goes amiss, we will share positive ideas and tidbits on what to do and how to do it.

Registration Fees & Deadlines

Free

Learning Objectives

After this webcast, you will be able to:

• 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.

Audience Learning Level

Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities.

Who Should Attend?

Regulatory professionals looking to improve the electronic submission process and/or how to avoid common submission mistakes.

Speakers:

Rachel Bombara

Rachel Bombara is a regulatory services manager at Certara Synchrogenix with more than a decade of experience in regulatory operations and helping sponsors achieve their eCTD submission goals. She has led and managed the submission of a variety of application types for different regions, from small amendments to large-scale original marketing applications, as well as mentored and trained others in eCTD publishing and submission management.