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Saturday, January 19, 2019
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Pharmaceutical Regulatory Affairs: The NDA Process: Requirements for Obtaining Approval for a New Drug in the USA (PRA007)

Certification Training 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.

THIS COURSE IS CURRENTLY NOT AVAILABLE.
Contact the BioPharma Institute for more information.

BioPharma Institute LogoTraining Program: Pharmaceutical Regulatory Affairs: The NDA Process: Requirements for Obtaining Approval for a New Drug in the USA
Training Provided By: BioPharma Institute
Website: https://www.biopharmainstitute.com

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:

  • Immediate access to training: Instructions, user name, 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 training: 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
  • 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
  • Career advancement: Professional certifications may be helpful for those seeking new careers or transitioning to different positions within their organization


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):


Professional Designation in US Pharmaceutical Regulatory Affairs: … Learn more


COURSE OUTLINE:


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.

NDAs: Content and formatting: This session provides an overview of the fundamental content and format requirements of an NDA for submission to the FDA. The four sessions that follow describe requirements for specific sections of the NDA. Chemistry, Manufacturing and Controls (CMC) information. The CMC information that must be detailed in the application is described in this session.

Nonclinical information: The nonclinical information that must be detailed in an NDA is described in this session.

Clinical and statistical information: This session provides an overview of the content and format requirements of the NDA’s clinical data section.

Administrative information: The content and format requirements of the index, labeling and application summary are addressed in this session.

NDA review and approval process: In this session, the review and approval process, and the FDA’s role and actions in it, are described.

Accelerated approval options: The FDA offers expedited approval programs for drugs designed to treat serious or life-threatening conditions that demonstrate the potential to address unmet medical needs. These programs are discussed in this session.

Key point summary: Key point summary for all topics covered in This online course. Ideal for review, a refresher or consolidation of learning points.

COURSE OBJECTIVES:


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.

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