Length of Course: Approximate time to complete this course is 1.5 hour(s).
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
Catalog: Pharmaceutical Regulatory Affairs.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.
PRICE: USD $145.00
Training Program: Regulatory Affairs: Preparing Submissions in the Common Technical Document (CTD) Format
Training Provided By: BioPharma Institute
Availability: Immediately available upon ordering.
Description: Online training with immediate access upon enrollment.
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. 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 BioPharma Institute
By employing advanced e-learning training techniques, and coupling them with new automated tracking systems, the BioPharma Institute provides professionally designed online courses which are effective at training, and assist those interested with advancing their careers. The BioPharma Institute also assists companies through maintaining training records, the education of their employees, and assisting them with improving their overall quality of service.
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.
The Regulatory Affairs: Preparing Submissions in the Common Technical Document (CTD) Format course is found in the following professional certification program(s):
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.
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.
All Courses in the Pharmaceutical Regulatory Affairs Catalog:
|Regulatory Affairs: Essentials for Human Medicinal Products - EU and US: This foundation-level training program is the ideal introduction for entrants new to the field of pharmaceutical compliance and regulatory affairs. It describes the principal requirements needed in order to mai ... Learn more|
|Regulatory Affairs: Orphan Drug Application - EU and US: Medicines for the prevention, diagnosis, or treatment of rare diseases have become known as 'orphan drugs' because they are commercially unattractive. Development of such products is successfully encouraged thr ... Learn more|
|Regulatory Affairs: Preparing Submissions in the Common Technical Document (CTD) Format: 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 ... Learn more|
|Regulatory Affairs: Electronic Common Technical Document (eCTD): The eCTD specification has been developed to facilitate the global electronic submission, review and lifecycle management of medicinal product dossiers for regulatory applications. It broadens the scope of the ... Learn more|
|Regulatory Affairs: How to Gain Approval to Market Generic Drugs in the US: This course outlines the legislative and regulatory context for the development of generic drugs and describes the essential role of the Abbreviated New Drug Application (ANDA) in gaining marketing approval. Th ... Learn more|
|Regulatory Affairs: Submitting a New Drug Application (NDA) to Obtain Approval to Market in the US: An NDA (New Drug Application) is a regulatory vehicle through which sponsors formally propose that the FDA approve a new drug for marketing and sale in the USA. For successful approval, what format and content ... Learn more|
|Regulatory Affairs: The European Centralized Procedure (CP): This online course describes the procedure's various players, the duration and sequence of the stages involved, and requirements on timing, format, and content of submissions. In the Centralized Procedure, one ... Learn more|
|Regulatory Affairs: The Mutual Recognition Procedure (MRP): The Mutual Recognition Procedure is one of three routes available to applicants to gain multinational Marketing Authorization within the European Economic Area (EEA) on the basis of a single application. A nati ... Learn more|
|Regulatory Affairs: Variations to Marketing Authorizations in Europe: Changes to the terms of marketing authorizations for medicinal products, called variations in Europe, must be notified to or approved by the relevant regulatory authorities. Variations include changes to the co ... Learn more|
|Regulatory Affairs: The Decentralised Procedure (DCP): The DCP is one of three routes available to applicants to gain multinational marketing authorization within the European Economic Area (EEA) on the basis of a single application. It can be used only for a produ ... Learn more|
|Regulatory Affairs: Registration of Drugs Based on Monoclonal Antibodies: This course addresses characteristic issues influencing the registration of medicinal products based on monoclonal antibodies (mAbs), for use in humans. Regulatory requirements for the registration of biologica ... Learn more|
|Regulatory Affairs: The Regulatory Pathway to Licensing Follow-on Biologics (Biosimilars) in the USA: The regulation of biological medicinal products is governed by different laws from those that apply to small-molecule synthetic drugs. Producing faithful copies of therapeutic proteins is more challenging than ... Learn more|
|Regulatory Affairs: Essentials of Monoclonal Antibodies: Monoclonal antibodies (mAbs for short) are the leading products of biotechnology. Drugs based on mAbs dominate the list of top-selling medicines worldwide. In addition, mAbs have many uses in medical diagnosis, ... Learn more|
Online Training: The Benefits of eLearning
- Immediate access to training: Instructions, username, password and receipt of payment emailed instantly upon online enrollment
- Optimized for learning: Courses include voice-overs, easy navigation, progress checks, and high-quality animations to increase retention of subject matter
- Self-paced courses: 24/7 access to individual courses for 90 days; and 180 days for professional certification programs
- Flexible final assessments: Tests include multiple-choice questions and can be taken repeatedly until a passing score is achieved
- Direct access to certificates: Documentation instantly available once course requirements have been fulfilled
- Verification of training: Certificates can be verified online, and electronic badges are issued for all Professional Certification programs
- Tuition reimbursement: Some employers may reimburse for training expenses; check on your company's requirements
- Purchase orders (POs) accepted: If POs are required, request an invoice to start the procurement process
- Corporate LMS compatibility: All courses are SCORM compliant and can be delivered from most corporate Learning Management Systems
- Secure and safe access: Website and LMS offer an encrypted connection with firewall protection and daily scans for optimal level of security and performance
- Career advancement: Professional certifications could be helpful for those seeking new careers or transitioning to different positions within their organization
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.