|Duration: 2 hours (the average time to complete the training program, including final assessments).
Credits Hours: 2
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.
THIS COURSE IS CURRENTLY NOT AVAILABLE.
Contact the BioPharma Institute for more information.
Training Program: Pharmaceutical Regulatory Affairs: Preparing Submissions in the Common Technical Document (CTD) Form
Training Provided By: BioPharma Institute
Availability: Immediately available upon ordering.
Description: Online training with immediate access upon enrollment. The CTD is the mandatory format for regulatory submissions in the European Union, Japan, Canada and Australia and strongly recommended in the USA. It is accepted widely elsewhere. This online course explains the rationale for the CTD and provides detailed guidance on its structure and format. Related documents such as Drug Master Files and Certificates of Suitability are also dealt with.
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 Pharmaceutical Regulatory Affairs: Preparing Submissions in the Common Technical Document (CTD) Form course is found in the following professional certification program(s):
Students completing this course should be able to: Describe the structure and format of the CTD and appreciate the rationale for it. Explain how to prepare submissions to regulatory authorities in all countries or regions where the CTD format is mandatory, recommended or accepted. Understand the differences between EU and US requirements and how to get guidance from the ICH and other regulatory authorities. Specify how to convert EU NTA and US FDA NDA formats to CTD section codes and headings.
For more information on the BioPharma Institute’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) 301-8370, or email Support@BioPharmaInstitute.com.