Enrollment Period: 6 months.
Average Learning Time: ~210 minutes.
Additional Resources: Supplemental materials/activities.
Accredited Program: 3.5 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.
Final Assessment: Multiple choice; unlimited attempts.
Certificate: PDF with validation code (See sample).
Price: $225.00 USD
Document your dedication to compliance, safety, and job performance by earning a training certification from Biopharma InstituteTraining Program: Regulatory Affairs: Submitting a New Drug Application (NDA) to Obtain Approval to Market in the US
Training Provided By: Biopharma Institute
Schedule: Self-paced. Immediate access to training materials 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.
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.
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.
Regulatory Affairs: Submitting a New Drug Application (NDA) to Obtain Approval to Market in the US is included in the following professional certification programs:
Price: $1795.00 (USD) | Learn more
Price: $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 which have been developed to promote the retaining of key knowledge, access to references, case studies, and other important information necessary to assist with learning. Since 2003, Biopharma Institute has been aiding both professionals and corporations with their training requirements. Biopharma Institute certifications are recognized by a wide spectrum of industries and companies, and our training solutions are customizable to any organization's training needs. Today, Biopharma Institute offers over 200 courses training on clinical research, drug manufacturing, regulatory affairs, validation systems, pharmacovigilance, good clinical laboratory practice (GCLP), data integrity, and medical devices.
Employee / Corporate Training: For corporations seeking a method to train employees, economically, without having to set aside time for travel, webinars, or live, in-person training, Biopharma Institute is the training partner you can rely on. Our training provides an effective, engaging, self-paced learning experience which fits conveniently into the day-to-day activities of most types of learners. Our eLearning modules are SCORM-compliant and can be delivered from most corporate learning management systems (LMS). We catering to both small-scale (1-100 students) and large-scale (100+ students) training requests.
Online Training: The Benefits of Remote Learning & eLearning
- Immediate access to training: Instructions, username, password, and receipt of payment are 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 for professional certification programs for 180 days.
- Flexible final assessments: Assessment testing include multiple-choice questions and can be taken repeatedly until a passing score is achieved.
- Direct access to certificates: Certificate of completion is instantly available once course requirements have been fulfilled.
- Verification of training: Certificates can be verified online, and digital badges are issued for all Professional Certification programs.
- Tuition reimbursement: Some employers may reimburse for training expenses; check on your company's training reimbursement policy.
- Financial assistance: Payment plans are available to those who qualify. These are offered when paying electronic invoices, online. You must first request an invoice to be considered. Alternatively, purchasing individual courses one at a time is also an option.
- Purchase orders (POs) accepted: If a PO is required by your company, 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 provide an encrypted connection with firewall protection and daily scans for optimal level of security and performance.
- Career advancement: Professional certifications help demonstrate your interest and dedication to job performance, and may be helpful for those seeking a new career or transitioning to different positions within their organization.