Who should attend
Core Learning Area
This online training on ANDA fling Strategic management provides training on the approval pathway, submission and strategic planning 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 and strategic management training course participants will learn about FDA requirements for for the content, submission, and review of ANDAs. Therefore, objective of this course is to provide hands on experience on ANDA filing process.
Most importantly, this course will provide comprehensive training on ANDA submission dossier preparation, filing 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.
- Title of the course: Competency Development Program in ANDA filing and strategic management
- Course Code: RYD-030
- Nature of the course: Online distance learning course. Therefore, the course can be accessed online across anywhere 24×7.
- Course duration: 1 Week
- Course certification: Certificate will be provided at the end of the successful completion of the course.
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.
Core Area of Learning in ANDA filing course
- First of all, the course covers fundamental of drug disovery development process.
- Followed by advanced understanding on generic drug approval process.
- Thirdly, the course covers Abbreviated New Drug Application (ANDA) submission process in detail.
- Most importantly, course provides in-depth understanding on the Chemistry, manufacturing and controls and ANDA Filing and submission dossier preparation.
- The course comprehensively covers ANDA strategic management aspects like therapeutic ratings, patent certification, First to File, Para IV Filing, Para IV notices, 180 days exclusivity.
- Concept and applicability of the GDUFA is one of the core aspects which discussed in the course. It covers Fees and FDA review timelines under GDUFA and Submission expectations and content under GDUFA.
Associate Must Have Key Learning Knowledge
- Drug Master Files and Site Master file preparation and filings are covered in the course.
- Next, under ANDA strategic management section, 505(b)(2), suitability petition application rationality and submission process explained in detail. In fact, course offers in-depth understanding on course 505 (b)(2) NDA. When does a “generic-like” drug become a 505 (b)(2) NDA.
- Also this course provides all inclusive understanding on Bioavailability and Bioequivalence study (BA BE study) which is key for ANDA approval.
- Above all, a brainstorming session includes in 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.
Few of the similar courses
- International Drug Regulatory Affairs
- Drug Biologic Medical Device Regulatory Affairs
- Medical Device Regulatory Affairs
- Drug Regulatory Affairs
- Bioavailability and Bioequivalence (BA / BE Study)
- Latam drug regulatory affairs
- European Drug Regulatory Affairs
- GCC Drug Regulatory Affairs
- UAE drug registration and approval
- Drug Registration and Regulation in China
- US (FDA) pharmaceutical and biopharmaceutical regulation
- Drug discovery development to commercialization
- Biopharmaceutical Regulatory Affairs
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