TypeOnline Course
Price$180 / Rs. 12500
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Admission Process

Admission Process

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Regulatory Norms are ever-changing. 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. In this course participants will learn about FDA regulations and expectations for the content, submission, and review of ANDAs and the importance of regulatory strategy in the age of GDUFA. The ANDA format and technical submission requirements, FDA expectations, fees, timelines under GDUFA, and the nuances of ANDA strategy for the regulatory professional including patent certification, and exclusivity periods will be discussed. The course will also focus on suitability petitions and the 505 (b)(2) NDA as a strategy option.

Core Area of Learning: Focused Area of learning: ANDA, Generic Drug Launching Strategies, Para IV, 180 Days Exclusivity Handling, Drug Master File, GDUFA, Suitability petitions, 505B(2), FDA meeting handling detailed understanding.

Duration: Access for 7 days

Course Code: KPE-C-052

Who should attend this course?

  • Those who are in strategic management or handling regulatory affairs of the generic drugs
  • Experienced staff from related disciplines, e.g. manufacturing, marketing and sales
  • Support staff
  • Anyone requiring an overview of ANDA and generic drug approval

Course Syllabus:

  • Fundamentals of the Abbreviated New Drug Application (ANDA)
  • Submission expectations and content under GDUFA
  • Chemistry, manufacturing and controls
  • Bioequivalence
  • Drug master files
  • Introduction to GDUFA. Fees and FDA review timelines under GDUFA
  • Overview of therapeutic ratings, patent certification, 180-day exclusivity
  • What is a suitability petition and when to submit one
  • When does a “generic-like” drug become a 505 (b)(2) NDA

Certification: Certificate will be provided at the end of the course after completion of the final examination.

Section 1Fundamental Understanding in Generic Drugs
Lecture 1Introduction to drug discovery
Lecture 2Concept of Generic Drugs
Lecture 3Detailed Understanding on ANDA
Lecture 4Generic Drug User Fees Act  (GDUFA)
Lecture 5Handling of orange book
Lecture 6Differentiation of 505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 7First to File Generics
Section 2Generic Drug - Strategic Understanding
Lecture 8Concept of Authorized Generics
Lecture 9Concept Building on LOE Strategies
Lecture 10Strategic Discussion on Evergreening - To Keep Generic Away
Lecture 11Advance Understanding on Para IV Filing
Lecture 12Para IV Notices - Handling and Managing
Section 3ANDA Application Filing
Lecture 13Introduction and Overview of ANDA Submission Format
Lecture 14ANDA Application Format
Lecture 15Detailed understanding of DMF
Lecture 16Pratical Understanding on DMF preparation and filing
Lecture 17Understanding on GDUFA, DMF Fees and ANDA Approval
Lecture 18Approval Pathway - 505(b)(2)
Lecture 19Prior Approval Submission (PAS)
Lecture 20ANDA Fees
Lecture 21505(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
Lecture 25Strategic Planning in Combating 30 months stay strategies of innovator company- Case Based Learning
Section 4Final Certification Examination