Student Login |


Saturday, June 24, 2017
Home » Online Training Course

Regulatory Affairs: Electronic Common Technical Document (eCTD) (PRA04)

Certification Training Duration: 2 hours (the average time to complete the training program, including final assessments).
Credits Hours: 2
CPD Accredited TrainingAccreditation: This training course offers CPD accreditation from the Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians.
CPD Credits: 2.5
Demonstration: Demo an online course.

Certificate: View sample certificate.

PRICE: USD $195.00

dinaris.org LogoTraining Program: Regulatory Affairs: Electronic Common Technical Document (eCTD)
Training Provided By: dinaris.org
Website: http://dinaris.org

Availability: Immediately available upon ordering.

Description: Online training with immediate access upon enrollment.

The Electronic Common Technical Document (eCTD) specification has been developed to facilitate the lifestyle management, review, and the global electronic submission of registration dossiers. It broadens the scope of the Common Technical Document to include information on amendments, renewals, and variations so that it is no longer a document which is static, but is updatable throughout the product’s life.

This online course details the Electronic Common Technical Document specification, provides guidance on the creation of the submission of an eCTD, and discusses the approach to regional differences in dossiers. This relatively fresh aspect of submissions will undergo significant and rapid changes as specifications are refined and modified further. This class is a superb training tool and reference and can be of assistance to anyone involved with electronic submissions and in navigating these changing requirements.

Once all course requirements have been satisfied, a certificate of completion is immediately available. Course takers can attempt the final assessment any number of times, as needed, in order to achieve the required 80% or better passing grade.

Benefits of Getting Certified at dinaris.org

By employing advanced e-learning training techniques, and coupling them with new automated tracking systems, the dinaris.org provides professionally designed online courses which are effective at training, and assist those interested with advancing their careers. The dinaris.org also assists companies through maintaining training records, the education of their employees, and assisting them with improving their overall quality of service.

Have Questions?

Should you have any particular question about this course, you can call us at (888) 111-1111 or send us an email at for more information.


Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment with >80% passing grade within a 90 day period of time (180 days for Professional Certification Programs). Certificate is accessible in PDF format immediately after satisfying requirements.

Online Training Programs Include:

  • Immediate access to training: Instructions, password, and username are emailed following order
  • 90 days of 24/7 access to individual training programs / 180 days for Professional Certification Program
  • Programs include voice-overs, easy navigation, progress checks, and high-quality animations
  • Course notes (in PDF) and/or references available with select training programs
  • Online final assessment with multiple-choice questions can be taken an unlimited number of times, until passing grade is achieved
  • A Certificate of Completion is immediately available once course requirements have been satisfied


The Regulatory Affairs: Electronic Common Technical Document (eCTD) Course is Found in the Following Professional Certification Program(s):


International Regulatory Affairs Professional Certification Program: This professional certification program includes descriptions of the decentralized procedure (DCP), EU variations procedure, the mutual recognition procedure (MRP), the European centralized procedure (CP); requ … Learn more

COURSE OUTLINE:


Introduction
This session defines the eCTD and identifies advantages of using this submission format.

Technical infrastructure
This session gives information on XML specification and style sheets and describes the eCTD backbone.

Directory structure
This session looks at the eCTD hierarchy, lifecycle management and structure of the five modules.

Submitting an eCTD
This session explores the workflow around planning and submitting an eCTD – particularly setting up the modules, migrating and validating the data, preparing the covering letter and submitting some eCTD parts on paper. It also reminds learners that a correctly completed eCTD is a valid legal document. Additional DTDs Canadian, EU, Japanese, American and STF DTDs are described.

Tools
This session includes a case study and an eCTD Checklist to assist learners when compiling an eCTD submission.

Summary
Key point summary for all topics covered in the module. Ideal for a refresher or consolidation of learning points.

COURSE OBJECTIVES:


Students completing this course should be able to:

–Describe the structure, requirements and functionality of the eCTD.

–Outline XML basics and the architecture of the eCTD.

–Discuss Document Type Defi nitions (DTDs).

–Explain how to build an eCTD. Specify regional differences.

–Discuss life cycle and change management.

–List criteria that will make an electronic application technically valid.

–Initiate electronic transfer to a regulatory authority.

–Create, submit and maintain an eCTD dossier throughout the life of a drug product.

JOB POSTINGS:

313 Regulatory jobs found.
Displaying jobs #1-4.

Regulatory Reporting Specialist
Posted Date: 2017-06-23
COOK MEDICAL – United States, IN, Bloomington, 47404

Clinical Research Regulatory Affairs Manager
Posted Date: 2017-06-19
Medix – United States, WA, Seattle, 98127

Regulatory Compliance Analyst
Posted Date: 2017-06-19
Apex Life Sciences – United States, MD, Rockville, 20849

Associate Director Regulatory Affairs CMC
Posted Date: 2017-06-21
Ascent Life Sciences – United States, MA, Waltham, 02254

See more Regulatory Jobs


For more information on the dinaris.org’s training programs, or to suggest a course, please complete the form located below. Alternatively, you may call toll free in the US: (888) 4-BIO-LRN, international callers can dial (201) 111-1111, or email Support@BioPharmaInstitute.com.

Information Request / Suggest a Course Form:

NAME:
COMPANY:
ADDRESS:
CITY:
STATE:
ZIP CODE:
COUNTRY:
PHONE:
EMAIL:
 
Enter the number from the image above
COMMENTS or Suggest a course:
(For pricing information, please provide us
with as much detail as possible about your training project):





   
метан