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

Understand the transition to the eCTD format.

In-person eCTD Training Workshops

July 2018 24–27 July 2018
US Pharmacopeial Convention
12601 Twinbrook Parkway
Rockville, MD 20852

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 requirement, 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
24–25 JULY 2018
ROCKVILLE, MD
REGISTER FOR INTERMEDIATE
26–27 JULY 2018
ROCKVILLE, MD


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. Recent changes:
  • This May, Health Canada requested input on establishing mandatory requirements for submitting drug master files (DMFs) when using the eCTD format. 
  • FDA has added new submission types in eCTD format.
 Training participants can receive up to 8 RAC Credits.

Feel you have a handle on current submission requirements?

Register for the intermediate course only.

 


Other upcoming eCTD training workshops

13–16 November 2018
New Horizons Learning Center
San Diego, CA 92126

  REGISTER FOR INTRODUCTION
13–14 NOVEMBER 2018
SAN DIEGO, CA
 REGISTER FOR INTERMEDIATE
15–16 NOVEMBER 2018
SAN DIEGO, CA

 

Not ready to register? Stay in the loop by signing up for the latest information about eCTD and other RAPS professional development programs.

 

Meet the Faculty

Eggers
Elsmari Eggers, designing and delivering training curriculum, training material for customer training as well as in-house on-boarding and refresher training. Elsmari has been leading eCTD training workshops and business analysis workshops at LORENZ customers, since 2012. In addition to RAPS, she presents eCTD courses at various universities in Germany and in Austria.






Keeling-(1).png
Nora Keeling, MPA has over six years of experience in regulatory operations and FDA submissions quality control (QC), including hands-on experience with numerous CTD and eCTD submissions. She works as an independent consultant with her own team, Professional eSubmission Services Inc., as well as part of the Mentara, Inc. consortium. She has participated in the successful project management, document processing, compilation and submission of numerous eCTD sequences. Nora is responsible for formatting QC, ensuring documents meet regulatory specifications, as well as submission compilation QC. Additionally, Nora is an industry trainer and instructor for RAPS, offering eCTD training workshops for regulatory professionals.



Mowrer.png
Marianne Mowrer is a regulatory operations consultant working with her own group, Professional eSubmission Services Inc., as well as Mentara, Inc., and Merchant-Taylor International, Inc. She has 17+ years’ experience preparing documentation and regulatory submissions for domestic and international pharmaceutical and biotechnology industries. Marianne and her team have successfully compiled and submitted over 1,000 submissions to multiple regulatory agencies, all without a single refuse-to-file. In addition to ongoing project management, submission planning, and compilation, Marianne is sharing her years of knowledge and experience with industry as a trainer and by serving as a Lead Instructor for RAPS’ eCTD training workshops.

 

 

 


 
 

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