Do not get behind on electronic submission requirements for commercial INDs and Master Files.  

In-person eCTD Training Workshops

11–14 June 2019
Loyola University Chicago- Water Tower Campus 
Philip H. Corboy Law Center
25 East Pearson Street
Chicago, IL 60611


  REGISTER FOR INTRODUCTION     REGISTER FOR INTERMEDIATE
 


Staying on top of submission requirements from the US Food and Drug Administration can be complicated. The transition to electronic has also made things more complex. Companies are slowly uncovering several burdens as they transition to the electronic common technical document (eCTD) format.

If you are not prepared, you can easily cost your company time and money.

To successfully meet the new eCTD requirements, RAPS offers in-person training workshops.

Objectives:

  • To understand the common submission intake process with CTD structure
  • Stay aligned with best practices that will lead to successful electronic regulatory applications
  • In-depth discussion followed by a lab practice for real world application

Who Should Attend:

These workshops are beneficial for professionals working in the drugs, biologics or combination products fields who are involved in the preparation of electronic submissions, particularly medical writers, regulatory operations and submissions publishing. There are no prerequisites and you do not have to be a RAPS Member to participate.

  REGISTER FOR INTRODUCTION
11–12 JUNE 2019
chicago, il
 REGISTER FOR INTERMEDIATE
13–14 June 2019
chicago, il


Which workshop should I take?

Both. To fully understand use of the eCTD format and the regulatory authority’s Common Electronic Submissions Gateway (CESG), it is best to take both the introduction and intermediate course. FDA and other leading regulatory authorities can adjust or make requirements changes at anytime.

 Training participants can receive up to 8 RAC Credits.

Feel you have a handle on submission requirements?

Register for the intermediate course only.

 


Additional 2019 Workshops

 
  • Introduction to Electronic Regulatory Submissions in the eCTD Format  
    • 12 Nov 2019 - 13 Nov 2019
      • Rockville, Maryland, USA
    • Register Now
  • Intermediate Course for Regulatory Submissions in eCTD Format  
    • 14 Nov 2019 - 15 Nov 2019
      • Rockville, Maryland, USA
    • Register Now
 

Stay in the loop by signing up for the latest information about next upcoming eCTD training and other RAPS professional development programs.


Meet the Faculty

Eggers
Patricki Champoux, senior sales executive, LORENZ Life Sciences  









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Parul Patel, trainer and regulatory support consultant, LORENZ Life Sciences. Parul performs product trainings and prepares training materials for various customers globally. In addition to representing LORENZ at RAPS workshops since 2016, she is leading the training for USFDA reviewers switching to docuBridge.








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Raj Thangavel, client services manager, North America, LORENZ Life Sciences. Raj performs installation, validation, system integration, data migration and configuration related client services within the North America region for LORENZ customers.