Duration: 2 hours, Online (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.
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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.
The Pharmaceutical 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: This part explains the rationale for the CTD, including information on the ICH and EU, US and Japanese regulatory authorities. It also gives information on full and abridged/abbreviated applications.
Use of the CTD: This part explains the format, data requirements and limitations of the CTD, differences between the EU and USA and how to get guidance from the ICH, US, EU and Japanese regulatory authorities. Information is also provided on drug master files, certification of suitability, formatting and updating the dossier.
Structure of the CTD: This part explains what should be included in the five courses of the CTD from an EU, US and Australian perspective.
Conversion of other Formats to CTD: Two tools are provided to assist with obtaining CTD section codes and headings from the old EU NTA format and US FDA NDA format.
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.
Online Training Program Benefits:
- 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
- Corporate reimbursements: Employers may pay for or reimburse employees for training. Purchase orders (POs) for both individual and group training are accepted
- Corporate LMS solutions: 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 may 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.