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Regulatory Affairs: How to Gain Approval to Market Generic Drugs in the US (PRA06)

Certification Training
 
Rated 4.33/5
9 reviews
Method of Training: Online / Self-paced eLearning.
Credits: 3.0 CPD Credits.
Duration: ~3.0 hour(s).
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
CPD Accredited TrainingCatalog: Pharmaceutical Regulatory Affairs.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.

PRICE: USD $225.00

Document a dedication to your career and job performance by earning a training certification from Biopharma Institute.

Biopharma Institute LogoTraining 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.

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 all course requirements have been satisfied, students will immediately receive a certificate of completion (PDF) and have been introduced to appropriate guidelines and pharmaceutical industry standards. This program assures that the student will understand the federal regulation compliances and how to conduct work which adheres to these standards.

This online training program includes immediate access after enrollment. Username, password, and instructions are emailed to the student following the enrollment into the program. Course takers can attempt the final assessment any number of times, as needed, in order to achieve a passing grade. Once all course requirements have been satisfied, a certification of training has been achieved and a certificate is immediately made available to the student.

Benefits of Getting Certified at Biopharma Institute

Throughout many of our courses, students will engage in active learning using interactive eLearning modules developed to promote the learning of key knowledge and information. For companies seeking a method to train employees, economically, without having to set aside an entire day for them to attend a live course, Biopharma Institute is the training partner you can rely on. Our training provides an effective, engaging, interactive, self-paced learning experience which fits in with most types of learners. We cater to both small-scale and large-scale training requests, customizing your employee's education.


Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment with passing score within a 90-day period of time (180 days for Professional Certification Programs). Certificate is accessible in PDF format immediately after satisfying requirements.


COURSE 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.

COURSE 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

The Regulatory Affairs: How to Gain Approval to Market Generic Drugs in the US Course is Included in the Following Professional Certification Programs:


International Pharmaceutical Regulatory Affairs Professional Certification Program: This professional certification program includes descriptions of the decentralized procedure (DCP), EU variations procedure, the mutual recognition procedure (MRP), the European centralized procedure (CP); requ ... Learn more

US Pharmaceutical Regulatory Affairs Professional Certification Program: This online professional certification program describes the essential requirements for obtaining approval of a new drug in the USA, the 'NDA Process'. The program describes preparing submissions using the Comm ... Learn more

Online Training: The Benefits of eLearning

  • Immediate access to training: Instructions, username, password, and receipt of payment are 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 courses: 24/7 access to individual courses for 90 days, and for professional certification programs for 180 days.
  • Flexible final assessments: Assessment testing include multiple-choice questions and can be taken repeatedly until a passing score is achieved.
  • Direct access to certificates: Certificate of completion is instantly available once course requirements have been fulfilled.
  • Verification of training: Certificates can be verified online, and digital badges are issued for all Professional Certification programs.
  • Tuition reimbursement: Some employers may reimburse for training expenses; check on your company's requirements.
  • Financial assistance: Payment plans are available to those who qualify. These are offered when paying electronic invoices, online. You must first request an invoice to be considered. Alternatively, purchasing individual courses one at a time is also an option.
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  • Career advancement: Professional certifications help demonstrate your interest and dedication to job performance, and may be helpful for those seeking a new career or transitioning to different positions within their organization.

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