Regulatory Affairs: Submitting a New Drug Application (NDA) to Obtain Approval to Market in the US
Enrollment Period: 12 months.
Average Learning Time: ~210 minutes.
Additional Resources: Supplemental materials/activities.
Accredited Program: 3.5 CPD Credits.
Method of Training: Online, asynchronous, 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: $225.00 USD
Document your dedication to quality, compliance, safety, and job performance by earning a training certification.Training 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 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 course and successfully pass an online, multiple-choice final assessment within a 12-month period. 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.
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:
Global Pharmaceutical Regulatory Affairs Professional Certification ProgramCourse ID: PRA00A1
Price: $1795.00.00 (USD) | Learn more
US Pharmaceutical Regulatory Affairs Professional Certification ProgramCourse ID: PRA00B1
Price: $1295.00.00 (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 relevancy 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.
Group Training for Employees: 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 and large-scale training requests, with the same goal in mind: To make this a good experience for everyone involved, from the students to those managing the group training.
Benefits of Training with Biopharma Institute
|Immediate access to courses:||Username, password, instructions, and receipt of payment are immediately emailed upon online enrollment.|
|Self-paced, asynchronous eLearning:||24/7 access to all course materials and assessments for 12 months.|
|Open enrollment:||No prior course prerequisites or work experience required.|
|Expertise:||Courses developed by subject matter experts (SMEs) in the area being taught.|
|Current and validated:||Training is current with respect to regulations, procedures, and 3rd party validated and/or accredited.|
|Optimized for learning:||Courses include voiceovers, easy navigation, reading materials, case studies, progress checks, and high-quality animations to increase retention of subject matter.|
|Secure and safe access:||Encrypted website and LMS connections, firewall, and daily malware scans deliver optimal security and performance.|
|Flexible final assessments:||Multiple-choice questions can be taken repeatedly until a passing score is achieved.|
|Direct access to certificates:||Certificate of completion is instantly available once requirements have been fulfilled.|
|Verification of training:||Certificates verifiable online with digital badges issued for all professional certification programs.|
|Training manager access:||A proprietary portal offers access to download enrollment reports, training records, account balance, and more.|
|SCORM-compliant courses:||Courses can be delivered directly to most corporate Learning Management Systems (LMS).|
|Purchase orders (POs):||POs are accepted from all companies. Request an invoice when starting the procurement process.|
|Reimbursement:||Some employers may reimburse their employees for training expenses. Check your company's policy.|
|Financial assistance:||Payment plans are available to those who qualify. Alternatively, purchasing individual courses one at a time is also an option.|
|Career advancement:||Professional certifications help demonstrate interest and dedication to career and job performance. They may be helpful for those seeking to grow their career or transitioning to a different position within an organization. Professional certifications are a great addition to a resume, offer talking points for the interview, and practical knowledge for performing duties.|