|Credits: 3.0 CPD Credits
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: How to Gain Approval to Market Generic Drugs in the US
Training Provided By: BioPharma Institute
Availability: Immediately available upon ordering.
Description: Online training with immediate access upon enrollment.
This course outlines the legislative and regulatory context for the development of generic drugs and describes the essential role of the Abbreviated New Drug Application (ANDA) in gaining marketing approval. The use of information in the ‘Orange Book’ is explained, as is the role of patent certification in the application. The importance of establishing bioequivalence between a generic and its reference product is emphasized. The module specifies the content and format requirements for an ANDA submission and describes the FDA’s review and approval process. An outline is given of the Generic Drug User Fee Amendments (GDUFA) and the law’s effects on industry players.
This course includes sections regarding bioequivalence, the Orange Book, the review and approval processes of ANDA, ANDA submission, patent certification, ANDA and generic drugs, and a regulatory overview.
The entire program must be viewed by students, and a multiple-choice, online final assessments must be completed with a passing grade of 75% or more. Once the program requirements are succeeded, a certificate of completion is immediately achieved. Course takers can attempt the final assessment any number of times, as needed, in order to achieve a passing grade.
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.
Online Training Programs Include:
The Regulatory Affairs: How to Gain Approval to Market Generic Drugs in the US course is found in the following professional certification program(s):
Module overview – An outline of the module’s scope and objectives, and notes on terminology.
Generic Drugs and the ANDA – An overview of the legislative and regulatory context for the development and approval of generic drugs, particularly the Hatch-Waxman Act; a summary of the criteria for therapeutic equivalence of drugs; obtaining guidance from the FDA; controlled correspondence.
Patent certification – The role of patent certification in an ANDA submission, the different types of certification, what happens when a patent is challenged, and the circumstances under which marketing exclusivity may be afforded to a generics sponsor.
The Orange Book – The use of the Orange Book in generic drug development, the format and content of the Book’s listings, and how to extract information for an ANDA.
Bioequivalence – The crucial importance of establishing bioequivalence with a reference listed drug; tests of bioavailability and bioequivalence; the statistical criteria for bioequivalence; waivers of in-vivo studies.
ANDA compilation and submission – Planning and managing an ANDA project; regulatory requirements on content and format; quality (CMC), labeling, and bioequivalence information; submitting an ANDA to the FDA’s Office of Generic Drugs.
ANDA review and approval – The process of review by the FDA; review duration and success rate; communication between applicant and FDA; expedited review; petitions; amendments and easily correctable deficiencies; outcomes of review, and the applicant’s options in response to those outcomes.
The Generic Drugs User Fee Amendments – The types of fees that the generics industry must now pay to the FDA; requirements for self-identification of generics industry players; the FDA’s performance goals for review and inspection; changes brought about by GDUFA II.
Assessment – Multiple-choice mastery assessment.
Who will benefit from this course?
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.