Who should attend
This advance online training provides fundamental understanding of ANDA and Para IV filing submission, process and strategic pathway. Regulatory Norms are ever-changing. There have been significant changes in FDA expectations of Abbreviated New Drug Applications (ANDAs). Since implementation of Generic Drug User Fee Act (GDUFA) in 2012, there is lot of changes in ANDA guideline. Therefore, there is also significant chnage in USFDA expectations regarding abbreviated new drug application. In this course participants will learn about FDA regulations and expectations. Course will effectively cover the content, submission, and review of ANDAs. Moreover, course will focus on regulatory strategy in the age of GDUFA.
The major part of the course will have detail explanation on concept of generic drugs and technical filing requirement. Course will also discuss about ANDA format. The other important topics which will be part of the course is FDA expectations, fees, timelines under GDUFA, and the nuances of ANDA strategy for the regulatory professional including patent certification, and exclusivity periods. The course will also focus on suitability petitions and the 505 (b)(2) NDA as a strategic option.
Core Area of Learning: ANDA, Generic Drug Launching Strategies, Para IV submission, 180 Days Exclusivity Handling, Drug Master File, GDUFA, Suitability petitions, 505B(2), FDA meeting handling detailed understanding.
- Course Title: RYD-051
Course Code: Fundamental Training on ANDA and Para Four Filing
- Duration of the course : 3 Days
- Nature of the course: Online micro learning course. So, course can be accessed online across anywhere 24×7.
Any body who wants to acquire competency regarding abbreviated new drug application process, should attend the course.
Who should attend this course?
- This course is ideal for those who requires detailed generic drug filing understanding. For example, those working in Analytical Development, Analytical Chemistry, Stability Testing, Formulation Development, Regulatory Affairs, Pharmaceutical & Biopharmaceutical Production, Product Development, Technical Operations.
- Fresher/Beginners, Those who want to make a career in drug regulatory or pharmaceutical products.
Certificate will be provided at the end of the successful completion of the course
Features of the course:
- This course provides detailed understanding on stability program which need to be adopted by the pharmaceutical producers. Hence, this course is ideal for the regulatory, QA/QC professions, or those who are handling drug dossier for regulatory submission.
- The course focus on the implementation of stability study.
- Moreover, course also provide clear cut understanding of the various stability zones.
- Finished pharmaceutical and active pharmaceutical ingredients stability program covers under the course.
Few of the similar courses
- ANDA filing strategic management
- US Pharmaceutical and Biopharmaceutical Regulatory Affairs
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- Drug Discovery and Development to Commercialization
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- UAE Drug Regulation and Registration
- Training on New Drug Application
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NDA and ANDA
- NDA means New Drug Application. New Drug application is the permission for market launch. When the sponsor of a new drug completes the entire clinical trial, they submit the new drug application to FDA for review. FDA review the drug’s safety and effectiveness of the new drug. Hence, new drug application is the key for launching of the new drug. In other words, when a pharmaceutical company develops a new drug, company must involve in the clinical trial. Clinical trial data is submitted to FDA for review along with the other prerequisite details. In fact, the FDA review is a comprehensive analysis of clinical trial data and other information prepared by the FDA drug application reviewers. A review is divided into sections on medical analysis, chemistry, clinical pharmacology, bio pharmaceutics, pharmacology, statistics, and microbiology.
- ANDA means Abbreviated New Drug Application. An abbreviated new drug application (ANDA) contains data that, when submitted to the FDA, provides for the review and ultimate approval of a generic drug product. Generic drug applications are called “abbreviated” because they are not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. Instead, a generic applicant must scientifically demonstrate that its product is bioequivalent (i.e., performs in the same manner as the original drug). Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the public.
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