Section 1Drug Discovery Development to Commercialization Training
Lecture 1R&D Process & Introduction to drug discovery
Lecture 2Investigational New Drug Application (INDA)
Lecture 3Basic concept and understanding of the Generic Drug
Lecture 4Basic concept and understanding of the Generic Drug
Lecture 5Abbreviated New Drug Application (ANDA)
Lecture 6Understanding the concept of authorized generics
Lecture 7Patent & Exclusivity Training - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Lecture 8Advance Understanding on Clinical Trial and Clinical Trial Management
Lecture 9Evergreening - Patent Life Extension Strategies
Lecture 10LOE Strategies for Innovator Brands with case study
Section 2Marketing Authorization Submission & Dossier Preparation Training
Lecture 11Submission Strategic Pathways : 505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 12Chemistry, Manufacturing & Controls
Lecture 13Advance Learning on 505B2 Pathway
Lecture 14FDA Forms and How to fill the resources
Lecture 15Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !
Lecture 16Advance study on Para IV Filing
Lecture 17Para IV Notices
Lecture 18Introduction to Common Technical Document (CTD)
Lecture 19Introduction to Electronic Common Technical Document (ECTD)
Lecture 20Advance Practical Training on Dossier Preparation focusing on drug registration in export countries
Lecture 21Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 22Black Box Warning
Lecture 23Importance of effective dossier management
Lecture 24Certificate of Analysis
Lecture 25Detailed Understanding on ANDA Submission Dossier
Lecture 26Prior Approval Submission
Lecture 27Key Consideration for Drug Master File Preparation and Submission
Lecture 28Practical Understanding on Drug Master File Preparation and Submission
Lecture 29Associated Learning: Site Master File - Detailed Understanding
Lecture 30DMF Completeness Assessment
Lecture 31Drug Master File - Fees
Lecture 32Drug Master File - Global Perspective [Across Different Regions]
Lecture 33Detailed Understanding on ANDA Fees
Lecture 34Detailed Understanding on 505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 35NCE Vs. 505b2 application - Case Based Learning
Lecture 36FTF - 180 Days Exclusivity - Case Based Learning
Lecture 37Classic case study of the 505b2 filing : Case Based Learning
Lecture 38Discussion on 85 common deficiency in CTD submission dossier
Lecture 39Full, Full-mixed, hybrid applications. Generic, Similar biologic application pathway, Well-established use application, Fixed combination application, Informed consent application
Lecture 40Data Exclusivity and Market Protection - Supplementary Patent Protection, Exclusivity, 6/10 Rule, 8+2+1 Formulae
Lecture 41Summary of Product Characteristics
Lecture 42Marketing Authorization Variation Types, Requirement & Planning - IA, IAIN, IB, II ; US FDA Variation AR, CBE-0, CBE-30, PAS - Strategic Discussion | Similarities & Differentiation
Section 3GMP - Quality Management System; Plant Inspection
Lecture 43GMP - Introduction and Important Discussion
Lecture 44Certification Pharmaceutical Companies / Plants
Lecture 45ISO Certifications
Lecture 46Premises & Plant Layout Designing
Lecture 47Sanitation and Hygiene
Lecture 48Equipment
Lecture 49Production Module
Lecture 50Documentation
Lecture 51Quality Control
Lecture 52Product Complaint
Lecture 53Storage Module
Lecture 54ISO and ISO Audits
Lecture 55Pharmaceutical SOPs Management from regulatory perspective
Lecture 56SOP Automation in Pharmaceutical Industry
Lecture 57Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter
Lecture 58Advance Training on Effective Management of Data Integrity issues in Pharmaceutical Industry