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Wednesday, December 01, 2021
Home » Regulatory Affairs: How to Gain Approval to Market Generic Drugs in the US

Regulatory Affairs: How to Gain Approval to Market Generic Drugs in the US

Certification Training
 
Rated 4.00/5
17 reviews
Program/Course ID: PRA06
Enrollment Period: 6 months.
Average Learning Time: ~180 minutes.
Additional Resources: Supplemental materials/activities.
Accredited Program: 3 CPD Credits.
Method of Training: Online / Self-paced eLearning.
Accessibility: 24/7 access to all program materials.
CPD Accredited TrainingCatalog: 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 Institute

Training Program: Regulatory Affairs: How to Gain Approval to Market Generic Drugs in the US
Training Provided By: Biopharma Institute
Website: https://www.biopharmainstitute.com

Schedule: Self-paced. Immediate access to training materials upon ordering.

Description: Online training with immediate access upon enrollment. Biopharma Institute Reviews

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.

The course is up to date with the many final and draft publications released by the FDA in US fiscal year (FY) 2017 that provide guidance for industry on applications for approval of generic drugs. It is also up to date with the provisions of the second authorization of GDUFA, applicable from FY 2018.

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.

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.


Outline:


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.

Objectives:


Who will benefit from this course?
This module will benefit staff working in regulatory affairs, medical affairs, clinical development, quality/CMC, analytical methods, and quality assurance departments, and other personnel who contribute to the development and registration of generic drugs.

Learning objectives
  • List the criteria for therapeutic equivalence of drugs
  • Outline the types of patent classification for an ANDA submission
  • Explain how to use the Orange Book in the development of a generic drug
  • Describe methods for determining bioequivalence of drug products
  • Outline the content and format requirements for an ANDA submission
  • Describe the ANDA review and approval process
  • Outline the provisions of the Generic Drug User Fee Amendments and summarize their effects on generics sponsors

Regulatory Affairs: How to Gain Approval to Market Generic Drugs in the US is included in the following professional certification programs:



Professional Certification Program:

International Pharmaceutical Regulatory Affairs Professional Certification Program

Course ID: PRA00A1
Price: $1795.00 (USD) | Learn more

Professional Certification Program:

US Pharmaceutical Regulatory Affairs Professional Certification Program

Course ID: PRA00B1
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.

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