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Sponsored Webcast: eCTD Submission Challenges (On-Demand)

1.0 RAC Credits Members: $0 | Nonmembers: $25
Sponsored Webcast: eCTD Submission Challenges (On-Demand)

This is an On-demand recording from March 2022.

This event is brought to you by:  

In the context of present and future state eCTD submissions, we will discuss:
  • Ad/Promo Submissions
  • BIMO Datasets
  • Clinical Data Management / Automation
  • Submission Planning

Regulatory affairs professionals become more keenly aware of industry trends through eCTD issue resolution.

In this virtual program, regulatory operations specialist Joshua Lett will examine several commonly seen eCTD submission challenges and discuss their resolutions. The presentation will explore the future of eCTD submissions and the practical applications of eCTD issue resolution in order to more proactively anticipate shifts in the industry. 

Learning Objectives 

Attendees will learn how to proactively prepare for the eCTD expectations of tomorrow by learning from current eCTD challenges, objectives, and trends.

Who Should Attend? 

  • Regulatory Affairs
  • Regulatory Operations
  • Technical editors/authors
  • Marketing and regulatory industry professionals
  • Marketing and regulatory industry leaders and decision-makers

Agenda

TBD 

The agenda may vary based on changing requirements.

Instructors:

Keri Wittekind

Keri Wittekind
Regulatory Operations Specialist II, Certara

Keri Wittekind is an experienced submission publisher, having supported numerous applications including NDAs, ANDAs, INDs, and maintenance submissions. For many of these, she was the point of contact for the regulatory affairs teams to ensure that all regulatory standards and requirements as well as the submission deadlines were met. Ms. Wittekind has an eye for detail from a previous position as an analytical data reviewer. She takes a proactive approach and prides herself on making personal connections to ensure smooth communication across a variety of teams and coworkers.

Carrie Ngangnang

Carrie Ngangnang
Senior Regulatory Operations Specialist, Certara

Carrie Ngangnang is a Senior Regulatory Operations Specialist with several years experience in regulatory operations electronic publishing, serving as project lead on multiple applications types and over 20 years serving in leadership roles, managing people and projects ranging from few to 300+.

Cancellation Policy

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 raps@raps.org. RAPS is unable to accept cancellations by phone. 

To transfer a registration, email raps@raps.org with the event title, name of the original registrant and the contact information for the new attendee. 

Proof of Attendance

RAPS will send an electronic letter or a certificate of attendance following the workshop.

Questions

Contact the RAPS Solutions Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email raps@raps.org  
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