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 $195.00
Training Program: Regulatory Affairs: Submitting a New Drug Application (NDA) to Obtain Approval to Market in the US
Training Provided By: BioPharma Institute
Availability: Immediately available upon ordering.
Description: Online training with immediate access upon enrollment.
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 requirements are needed in order to comply with guidelines set up by the FDA? How does one plan a submission timetable? This course provides answers to these questions, and will assist regulatory professionals with understanding the requirements to, not only complete NDA's for approval by the FDA, but also how to submit them for approval.
This course includes a general overview, sessions on administrative information, statistical and clinical information, nonclinical information, CMC (chemistry, manufacturing, and controls) information, NDAs: content and formatting, accelerated approval options, NDA review and approval process, and a key point summary.
The entire program must be viewed by students in order to pass. An online, multiple-choice final assessment score of 80% or better is required. Course takers can attempt the final assessment any number of times, as needed, in order to achieve a passing grade of 75% or greater. Once all course requirements have been satisfied, a certificate of completion is immediately available.
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: Submitting a New Drug Application (NDA) to Obtain Approval to Market in the US course is found in the following professional certification program(s):
Overview - Provided in this session is information on the module: the scope, the areas not covered, module objectives and US legislative framework. The background and history of NDAs is also included in this session.
Introduction - This session defines the NDA, outlines the history of related legislation, describes desirable interaction with the FDA, and introduces the US regulatory framework.
High-level content and formatting - This session provides an overview of the fundamental content and format requirements of an NDA for submission to the FDA.
Quality information - The chemistry, manufacturing and controls information that must be detailed in the application is described in this session.
Nonclinical information - The nonclinical information that must be provided in an NDA is summarized in this session.
Clinical information - This session sets out the components of the clinical information required in an NDA.
Administrative information and summary - The administrative and prescribing information and the summaries required in an NDA are outlined.
NDA review and approval process - Details of the FDA's review and approval process are provided.
Expedited development and review - This session describes priority review, accelerated approval, fast track development, and breakthrough therapy designation.
Assessment - Multiple-choice mastery assessment.
Who will benefit from this course?
This module is intended primarily for regulatory affairs professionals who are new to the NDA or who seek a refresher course. It will also be of interest to others involved in drug development and/or who interact with the FDA.
- Summarize the content and format requirements for a New Drug Application.
- Outline the procedural requirements for an NDA submission to the FDA.
- Describe the role of the FDA in the NDA review and approval process.
- List the principal provisions available from the FDA for expedited drug development and review, and summarize the criteria that apply to them.
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.