Regulatory Affairs: Preparing Submissions in the Common Technical Document (CTD) Format
 | 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. Catalog: Pharmaceutical Regulatory Affairs.Demonstration: Five (5) free trial courses are available. Group/Employee Training: Click here to request a quote. Final Assessment: Multiple choice; unlimited attempts. Certificate: PDF with validation code (See sample). Price: $145.00 USD |
Document your dedication to quality, compliance, safety, and job performance by earning a training certification.Training Program: Regulatory Affairs: Preparing Submissions in the Common Technical Document (CTD) FormatTraining Provided By: Biopharma Institute Website: https://www.biopharmainstitute.com Schedule: Self-paced. Immediate access to training materials upon enrollment. Description:  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 course and successfully pass an online, multiple-choice final assessment within a 6-month period, or a 12-month period for professional certification programs. A certificate of completion is immediately accessible in PDF format after satisfying the requirements. Biopharma Institute certificates and digital badges include the date of completion, but do not have an expiration date. However, compliance training is typically considered valid for a period of 3 years. Many organizations suggest that compliance training should be refreshed at least every three years to stay up to date with regulations, standards, guidelines, and to reinforce the importance of maintaining compliance. The validity period for employee compliance training would be determined by those responsible for managing quality assurance. Biopharma Institute's online training courses include immediate access after enrollment. Username, password, and instructions are emailed to the student directly following online enrollment into the program. Course takers may attempt the final assessment any number of times, as needed, to achieve a passing score. The certificate of completion is instantaneously launched and made available to the student in a PDF format upon completion. Once all training requirements have been satisfied the achievement can be verified from our website using the unique ID code found on the certificate. Professional certification programs issue a digital badge to verify training and document the achievement. These digital badges can be displayed on social networking sites, such as LinkedIn, Facebook, Twitter, and Badgr. |
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
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Regulatory Affairs: Preparing Submissions in the Common Technical Document (CTD) Format is included in the following professional certification programs:
 | Global Pharmaceutical Regulatory Affairs Professional Certification ProgramCourse ID: PRA00A1Price: $1795.00 (USD) | Learn more | |
 | US Pharmaceutical Regulatory Affairs Professional Certification ProgramCourse ID: PRA00B1Price: $1295.00 (USD) | Learn more |
Benefits of Being Certified from Biopharma Institute: Throughout many of our online training programs students will be engaging in active learning through the use of interactive eLearning modules validated by 3rd party organizations for relavancy and regulatory content. The courses are developed by subject matter experts (SMEs) to promote the retaining of key knowledge. They offer access to regulatory references, real-life case studies, and introduce other important information necessary to assist with learning. Since 2003, Biopharma Institute has been aiding both professionals and their corporate employers with fulfilling training requirements. Biopharma Institute's certifications are recognized by a wide spectrum of industries, regulators, and companies around the world. Furthermore, our training solutions are customizable to any organization's training needs. Today, Biopharma Institute offers over 200 courses training on clinical research, drug manufacturing (cGMP), regulatory affairs, validation systems, pharmacovigilance, good laboratory practice (GLP), and data integrity for the clinical research, pharmaceutical, and medical device industries.
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