Change title to: Sponsored Webcast: Preparing for Tomorrow’s eCTD Submission Challenges (On-Demand).

1.0
RAC Credits
Virtual Programs Virtual Programs
Thursday, 17 March 2022 (11:00 AM) - Thursday, 17 March 2022 (12:00 PM) Eastern Time (US & Canada)

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:

Joshua Lett

Joshua Lett is a knowledgeable, technically proficient, and quality-driven Regulatory Operations professional, with eight years of industry experience. Throughout his Regulatory career he has led many different eCTD drug-therapy submissions from inception to successful transmission through the ESG to governing health agencies such as the U.S. FDA and Health Canada. These eCTD drug-therapy projects include Initial IND and NDA Milestone submissions, Lifecycle, and Advertising and Promotional Material submissions. He has been a member of the Certara Synchrogenix organization since 2018.

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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