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Communication Strategies. Case Studies. Applied Knowledge.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Oops, I made a mistake! Everyone has made or seen one, and sometimes it is embarrassing to discuss. This webinar 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.
After this webcast, you will be able to:
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.
Regulatory professionals looking to improve the electronic submission process and/or how to avoid common submission mistakes.
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.
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.
All cancellation requests must be submitted in writing to firstname.lastname@example.org. RAPS is unable to accept cancellations by phone.
To transfer a registration, email email@example.com with the event title, name of the original registrant and the contact information for the new attendee.
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email firstname.lastname@example.org.