Regulatory Affairs: Preparing Submissions in the Common Technical Document (CTD) Form (PRA03)
|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: 1.5
Demonstration: Demo an online course.
Certificate: View sample certificate.
PRICE: USD $195.00
Training Program: Regulatory Affairs: Preparing Submissions in the Common Technical Document (CTD) Form
Training Provided By: dinaris.org
Availability: Immediately available upon ordering.
Description: Online training with immediate access upon enrollment.
The Common Technical Document (CTD) is the mandatory format for regulatory submissions in Australia, Canada, Japan, the European Union, and, for the United States of America, it is strongly recommended. It is widely accepted elsewhere, as well. This class explains the rationale for the Common Technical Document and provides detailed guidance on its format and structure. Related documents such as Certificates of Suitability and Drug Master Files are also discussed.
This course discusses the regulatory approval of the Common Technical Document, the use of the Common Technical Document and its structure, and the conversion of other formats to Common Technical Document.
A passing grade of 80% or more is required. 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 a 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: Preparing Submissions in the Common Technical Document (CTD) Form Course is Found in the Following Professional Certification Program(s):
Regulatory Approval and the CTD
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.