Introductory and Intermediate eCTD Trainings 

Do you need to comply with the May 2018 electronic submission requirements for commercial INDs and Master Files?

The deadline is fast approaching for your company to migrate to electronic-only regulatory submissions based on the required ICH eCTD format. To successfully meet the new requirements, organizations need to understand the underlying CTD structure upon which electronic submissions are built, and suggestions for implementing operational changes that will lead to successful electronic regulatory applications.

RAPS is the place to start

RAPS offers two types of face-to-face training workshops on the eCTD for regulatory professionals who need to learn how to comply with the May 2018 requirements. The courses are offered to both members and nonmembers and can be taken together or independently:

What to expect at our eCTD Trainings

  • Tips, tricks and best practices gathered from industry professionals
    • Which types of applications need to be submitted electronically
    • Which agency guidelines and technical specifications publishers need to follow
    • Converting from a paper application to an eCTD
    • What eCTD readiness really means
  • Hands-on Lab Practice with sample software
    • How to apply ICH and regional requirements to your eCTD
    • How to compile documents into the XML backbone of an eCTD, and lifecycle that application
    • How to QC and validate an eCTD
    • How metadata and study tagging files work
Training participants can receive up to 8 RAC Credits.

Faculty

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Nora Keeling, M.P.A. – Nora Keeling, M.P.A., 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 the Regulatory Affairs Professional Society (RAPS) organization, offering eCTD training workshops for regulatory professionals.


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Marianne Mowrer – 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 Regulatory Affairs Professionals Society (RAPS) eCTD workshops.

 

Which workshop should I take?

  • Introduction workshop is geared to understanding the CTD structure and how it transfers to eCTD. Attendees will dig deep into the fundamentals of creating FDA-compliant PDF files.
  • Intermediate workshop is targeted toward professionals who have a working knowledge of the CTD format and paper submission process. Attendees will review eCTD submission options and the relationship of authors and publishing.
Introduction Course to Electronic Regulatory Submissions in the eCTD Format
April 10-11

10-11 April 2018
San Diego, CA


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Early Bird
Member Price: $1,250
Non-member Price: $1,350

Regular
Member Price: $1,350
Non-member Price: $1,450
July 24-25

24-25 July 2018
Rockville, MD


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November 13-14

13-14 Nov 2018
San Diego, CA


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Intermediate Course to Electronic Regulatory Submissions in the eCTD Format
April 12-13

12-13 April 2018
San Diego, CA


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Early Bird
Member Price: $1,350
Non-member Price: $1,450

Regular
Member Price: $1,450
Non-member Price: $1,550
July 26-27

26-27 July 2018
Rockville, MD


Register
November 15-16

15-16 Nov 2018
San Diego, CA


Register

 

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