|Duration: 2 hours (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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Training Program: Pharmaceutical Regulatory Affairs: The NDA Process: Requirements for Obtaining Approval for a New Drug in the USA
Training Provided By: BioPharma Institute
Availability: Immediately available upon ordering.
Description: Online training with immediate access upon enrollment. A New Drug Application (NDA) is a regulatory vehicle through which Sponsors formally propose that the FDA approve a new drug for sale and marketing in the USA. For successful FDA approval, what content and format requirements are necessary to comply with FDA guidelines? How do you plan your submission timetable? This online course provides regulatory professionals with the requirements to complete and submit NDAs for FDA approval.
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.
Online Training Programs Include:
The Pharmaceutical Regulatory Affairs: The NDA Process: Requirements for Obtaining Approval for a New Drug in the USA course is found in the following professional certification program(s):
Overview: Provided in this session is information on The course: the scope, the areas not covered, course objectives and US legislative framework. The background and history of NDAs is also included in this session.
Students completing this course should be able to: Outline the format and content requirements of a New Drug Application (NDA). Outline the necessary forms required for an NDA application. Review an NDA via a checklist prior to submitting it to the FDA. Summarize the role of the FDA in the NDA review and approval process. Define the programs implemented by the FDA to expedite the drug development and approval process.
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.