Who should attend
Core Learning Area
This self paced online course on ANDA fling and Strategic management provides training on the Abbreviated New Drug Application (ANDA) filing process.
Regulatory Norms are ever-changing. Hence, there have been significant changes in FDA expectations of Abbreviated New Drug Applications (ANDAs) since the passage of the Generic Drug User Fee Act (GDUFA) in 2012. So, in this Abbreviated New Drug Application filing training course participants will learn about FDA requirements for for the content, submission, and review of ANDAs. Most importantly, this course will provide comprehensive training on ANDA submission dossier and related important topics. For example, ANDA format and technical submission requirements, FDA expectations, fees, timelines under GDUFA. Above all, the course will cover comprehensive strategic planning for the regulatory professional including patent certification, patent and exclusivity periods, Para IV certification, 180 days exclusivity, suitability petitions and the 505 (b)(2) NDA pathway. To sum up, this course focus on the ANDA filing and strategic management steps which is must learn course for regulatory affairs, business development, strategic management professionals.
Course Title: Competency Development Program in ANDA filing and strategic management
Course Code: RYD-030
Online distance learning course. Therefore, the course can be accessed online across anywhere 24×7.
This ANDA filing training course utilizes interactive learning tools to guide each participant through to understand of the abbreviated new drug application filing process. Indeed, advance simulation in the Abbreviated New Drug Application course will challenge students to apply what they have learned from the course. In addition, there are advance learning tools like interactive exercises, reflection questions, expert live chat which makes the course very interesting.
Key features of the course
- 24×7 Online Access. Therefore, access the course anytime from anywhere across globe.
- Students can download the course materials from dashboard. Hence, it helps them to study offline even after completion of the course.
- Access the e-lectures, case studies, self assessment modules and practical sessions through personalized web page.
- Moreover, final examination is online. Hence student can attend the final examination own convenient date and time.
Anyone who want to enhance the knowledge about Abbreviated New Drug Application Filing.
Core Area of Learning in ANDA filing course
- Fundamentals of the Abbreviated New Drug Application (ANDA).
- Generic Drug Launching Strategies.
- Para IV Filing, Para IV notices.
- 180 days exclusivity.
- GDUFA. Introduction to GDUFA. Fees and FDA review timelines under GDUFASubmission expectations and content under GDUFA.
- Chemistry, manufacturing and controls.
- ANDA Filing and submission dossier preparation.
- Drug Master Files.
- Site Master Files.
- Overview of therapeutic ratings, patent certification, 180-day exclusivity.
- What is a suitability petition and when to submit one.
- 505 (b)(2) NDA. When does a “generic-like” drug become a 505 (b)(2) NDA.
- Above all, FDA meeting and handling FDA expectation.
Who should attend this course?
- Those who are in strategic management or handling regulatory affairs of the generic drugs.
- Who are working on ANDA filing, requires clear cut understanding on FDA submission process.
- Similarly, those who require an overview of ANDA and generic drug approval.
- Regulatory strategic professions who requires in depth training on the ANDA and generic drugs.
- Experienced staff from related disciplines, e.g. manufacturing, marketing, strategic management, business development professionals.
Certificate will be provided at the end of the successful completion of the course.
- Attend the course 24×7 by login to your dashboard. So, you can attend lectures, simulation, self assessment tests and final certification examination.
- You will also eligible to receive the course study modules, which you can download by login to your course page.
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What is ANDA?
An Abbreviated New Drug Application (ANDA) is an application for a U.S. generic drug approval for an existing licensed medication or approved drug. After that, ANDA is submitted to FDA’s Center for Drug Evaluation and Research, Office of Generic Drugs, which provides for the review and ultimate approval of a generic drug product. Once approved, an applicant may manufacture and market the generic drug product. Above all, it will provide a safe, effective, low cost alternative to the American public.
About Abbreviated New Drug Application (ANDA)>> Learn here