Regulatory Affairs: Electronic Common Technical Document (eCTD) (PRA04)
|Duration: 2 hours (the average time to complete the training program, including final assessments).
Credits Hours: 2
Accreditation: 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
Training Program: Regulatory Affairs: Electronic Common Technical Document (eCTD)
Training Provided By: 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.
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:
The Regulatory Affairs: Electronic Common Technical Document (eCTD) Course is Found in the Following Professional Certification Program(s):
Students completing this course should be able to:
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
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.