Regulatory Affairs: How to Gain Approval to Market Generic Drugs in the USA
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Price: $225.00 USD  |
Download Showcase your commitment to quality, compliance, safety, and professional excellence by earning a recognized certification of training.Training Program: Regulatory Affairs: How to Gain Approval to Market Generic Drugs in the USATraining Provided By: Biopharma Institute Website: https://www.biopharmainstitute.com Schedule: Self-paced eLearning. Immediate access to training materials upon enrollment. Description:  Learn the complete process for developing and gaining approval for generic drugs in the USA. This course explains the role of the Abbreviated New Drug Application (ANDA), the importance of bioequivalence, and the FDA's review and approval process. You'll also explore the impact of the Generic Drug User Fee Amendments (GDUFA) and how to use the FDA's Orange Book to your advantage.
Take the next step in your professional growth and earn an industry-recognized certification from Biopharma Institute -designed for professionals who want to excel in ensuring the safety and effectiveness of medicinal products. These programs not only give you up-to-date regulatory and compliance insights but also deliver practical skills that employers value. Whether you're enhancing your current role or preparing for a new opportunity, Biopharma Institute certifications are designed to set you apart in the competitive and highly regulated pharmaceutical industry. |
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
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 | Global Pharmaceutical Regulatory Affairs Professional Certification ProgramProgram ID: PRA00A1Price: $1795.00 (USD) |
 | US Pharmaceutical Regulatory Affairs Professional Certification ProgramProgram ID: PRA00B1Price: $1295.00 (USD) |
Certification Requirements: To earn a certificate, students must complete the entire course and pass an online, multiple-choice final assessment within 12 months of enrollment. Upon meeting these requirements, a certificate of completion is instantly available in PDF format.
Biopharma Institute's online training provides immediate access after enrollment. Students receive their username, password, and instructions via email directly after registering. The final assessment can be attempted as many times as necessary to achieve a passing score. Once the course is successfully completed, the certificate is generated instantly in an encrypted PDF format, featuring a watermark, unique validation code, and QR verification barcode.
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Since 2003, Biopharma Institute has helped professionals and their employers meet training requirements. Our certifications are recognized by a wide range of industries, regulatory bodies, and organizations worldwide. Training solutions can be customized to meet the needs of any organization. We currently offer over 300 courses covering topics such as clinical research, drug manufacturing (cGMP), regulatory affairs, validation systems, pharmacovigilance, good laboratory practice (GLP), and data integrity, serving the clinical research, pharmaceutical, and medical device sectors.
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Benefits of Training with Biopharma Institute
| Immediate Course Access: | Login details, instructions, and payment confirmation are emailed immediately upon online enrollment. |
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