InstructorRoyed Training
TypeOnline Course
Student Enrolled1
Price$290 USD / 15950 INR
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About ANDA

ANDA Filing and strategic management

This online training on ANDA fling Strategic management provides training on the approval pathway, submission and strategic planning process.
anda filing strategic management

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 the content, submission, and review of ANDAs. Therefore, the objective of this course is to provide hands-on experience on the 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 focuses on the ANDA filing and strategic management steps which is a must learn course for regulatory affairs, business development, and strategic management professionals.

Course snapshots

  • 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 the globe.
  • Students can download the course materials from the 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 pages.
  • Moreover, the final examination is online. Hence students can attend the final examination at their own convenient date and time.

Core Area of Learning in ANDA filing course 

  • First of all, the course covers the fundamentals of the drug discovery 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, the 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 is 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 generic drugs.
  • Who is working on ANDA filing, requires a clear cut understanding of the FDA submission process.
  • Similarly, those who require an overview of ANDA and generic drug approval.
  • Regulatory strategic professions who require in depth training on the ANDA and generic drugs.
  • Experienced staff from related disciplines, e.g. manufacturing, marketing, strategic management, business development professionals.

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

Section 1Introduction to ANDA | ANDA Submission Process
Lecture 1R&D Process & Introduction to drug discovery
Lecture 2Investigational New Drug Application (INDA)
Lecture 3New Drug Application (NDA) 
Lecture 4Basic concept and understanding of the Generic Drug
Lecture 5Abbreviated New Drug Application (ANDA) 
Lecture 6Practical Training on INDA, NDA, ANDA filing
Lecture 7505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 8Authorized Generics: Key Understanding
Lecture 9Advance Learning on 505B2 Pathway
Lecture 10Chemistry, Manufacturing & Controls 
Lecture 11Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Lecture 12FDA Forms and How to fill the resources
Lecture 13Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !
Lecture 14ANDA Submission Format: Common Technical Document (CTD) | Advance training on CTD filing
Lecture 15Electronic Common Technical Document (ECTD)
Lecture 16Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 17Importance of effective dossier management
Lecture 18Detailed Understanding on ANDA Submission Dossier 
Lecture 19Prior Approval Submission 
Lecture 20Detailed Understanding on ANDA Fees
Lecture 21Detailed Understanding on 505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 22NCE Vs. 505b2 application - Case Based Learning 
Lecture 23FTF - 180 Days Exclusivity - Case Based Learning
Lecture 24Classic case study of the 505b2 filing : Case Based Learning
Lecture 25Strategic Planning in Combating 30 months stay strategies of innovator company- Case Based Learning
Lecture 26Discussion on 85 common deficiency in CTD submission dossier
Lecture 27Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter 
Lecture 28Data Integrity issues in Pharmaceutical Industry
Lecture 29Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity
Lecture 30Stability Testing Requirement for ANDA
Lecture 31Key Consideration for Drug Master File Preparation and Submission 
Lecture 32Practical Understanding on Drug Master File Preparation and Submission
Lecture 33Site Master File - Detailed Understanding 
Lecture 34Drug Master File - Fees
Lecture 35ANDA Annual Report
Lecture 36Changes in approved ANDA
Lecture 37Introduction to Variation Management | Reasons for Variation | Working in Variation Department 
Lecture 38Variation Classification | Basis of Classification | US and EU Variation Classification | Other region variation guideline.
Section 2Strategic Planning related to ANDA management
Lecture 39Regulatory Strategies in different phases of Clinical Trial
Lecture 40Advance study on Para IV Filing
Lecture 41Para IV Notices
Lecture 42Evergreening - Patent Life Extension Strategies
Lecture 43Pay For Delay Strategy
Lecture 44LOE Strategies for Innovator Brands with case study
Lecture 45ANDA Case Study
Lecture 46ANDA case study
Lecture 47ANDA case study
Lecture 48ANDA Case Study
Section 3Bioavailability (BA) and Bioequivalence (BE) Study
Lecture 49PKPD in Drug Discovery | PK-PD trial | Understanding PKPD from regulatory perspective in drug approval process
Lecture 50Bioequivalence Study | Study design | Different types of BE Studies
Lecture 51Bioequivalence Study | Study design | Parallel Study | Crossover study design | Other alternative study designs | Blood Sampling Planning  | Analyte | Bioanalytical Methods Validation  | Statistical Model  | Ln Transformation  | Dose normalisation | Confidence interval acceptance criteria
Lecture 52Biopharmaceutical Classification System (BCS) | Types | Biowaivers | BCS tool for drug development and regulatory submission 
Lecture 53Bioequivalence Study - Discussion - Timeline of stability study and bioequivalence study 
Lecture 54Bioequivalence Study - Discussion - Dissolution Testing
Lecture 55Bioequivalence Study - Generic Approval and Additives Labeling Requirements 
Lecture 56IVIVC - Importance | Significance | Case Study on IVIVC level