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Home » Regulatory Affairs: Preparing Submissions in the Common Technical Document (CTD) Format

Regulatory Affairs: Preparing Submissions in the Common Technical Document (CTD) Format

Certification Training
 
Rated 4.15/5
20 reviews
Program/Course ID: PRA03
Enrollment Period: 6 months.
Average Learning Time: ~90 minutes.
Additional Resources: Supplemental materials/activities.
Accredited Program: 1.5 CPD Credits.
Method of Training: Online / Self-paced eLearning.
Accessibility: 24/7 access to all program materials.
CPD Accredited TrainingCatalog: Pharmaceutical Regulatory Affairs.
Demonstration: Five (5) free trial courses are available.
Final Assessment: Multiple choice; unlimited attempts.
Certificate: PDF with validation code (See sample).
  Price: $145.00 USD  

Document your dedication to compliance, safety, and job performance by earning a training certification from Biopharma Institute

Training Program: Regulatory Affairs: Preparing Submissions in the Common Technical Document (CTD) Format
Training Provided By: Biopharma Institute
Website: https://www.biopharmainstitute.com

Schedule: Self-paced. Immediate access to training materials upon ordering.

Description: Online training with immediate access upon enrollment. Biopharma Institute Reviews

The CTD is the internationally recognized standard format for submissions to medicines regulatory authorities. Its use is mandatory for all applications in the European Economic Area, required for prescription drugs in Japan and elsewhere, and accepted by a growing number of other national regulators. Use of the electronic version of the CTD is mandatory for applications for marketing approval and all subsequent submissions in the USA. This module explains the rationale for the CTD and provides guidance on its structure and format and the ways in which it is used.

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 75% or more is required.

Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment within a 90-day/3-month period (180 day/6-month period for Professional Certification Programs). Certificate of completion is accessible in PDF format immediately after satisfying requirements.

Biopharma Institute's online training programs include immediate access after enrollment. Username, password, and instructions are emailed to the student following enrollment into the program. Course takers can attempt the final assessment any number of times, as needed, to achieve a passing score. Once all training requirements have been satisfied a certification of training has been achieved and can be verified immediately from our website using a unique certification ID code. The certificate of completion is also instantaneously launched and made available to the student in a PDF format upon completion. Professional certification programs additionally include a digital badge to verify training, and can be displayed on social networking sites, such as LinkedIn.


Outline:


Introduction - This session introduces you to the nature of the Common Technical Document (CTD), a global standard designed by the ICH (International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use). The composition of a regulatory submission team is outlined.

High-level structure - In this session you will become more familiar with the five modules of the CTD.

Fine structure and format - You will be given access to guidelines that specify in detail the structure of each module of the CTD and the relationship between their sections and the documents that make up a dossier. Recommendations are also given on how to segregate and paginate documents and how to format pages, tables of contents and cross-references.

Using the CTD - Different ways in which you can use the CTD in practice are described. Production of a CTD dossier in both paper and electronic format is outlined.

Conversion tools - Two tools allow you to convert section headings in the old EU NTA format or the US NDA format to their equivalents in the CTD.

Assessment - Multiple-choice mastery assessment.

Objectives:


Who will benefit from this module? Regulatory affairs and compliance staff, and all those involved in drug development and who contribute to regulatory submissions, will find the module an invaluable introductory training course and/or a useful reference tool. Specialists in data handling, knowledge management or documentation will also wish to familiarize themselves with its contents.

Objectives
  • Explain the rationale for the CTD, and describe the ways in which it is used.
  • Identify regional differences in regulatory requirements for information in a CTD-formatted submission.
  • Describe the structure of the CTD.
  • Access guidance on detailed structure and content of the CTD.
  • Outline formatting requirements for a CTD dossier.
  • Convert EU NTA and US NDA section codes and headings to their CTD equivalents.

Regulatory Affairs: Preparing Submissions in the Common Technical Document (CTD) Format is included in the following professional certification programs:



Professional Certification Program:

International Pharmaceutical Regulatory Affairs Professional Certification Program

Course ID: PRA00A1
Price: $1795.00 (USD) | Learn more

Professional Certification Program:

US Pharmaceutical Regulatory Affairs Professional Certification Program

Course ID: PRA00B1
Price: $1295.00 (USD) | Learn more

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