Introduction
Features
Duration
Biologic Regulatory Affairs online course provides training on biotech and biosimilar drugs development process and regulation. The course is designed to challenge users to apply what they have learned through the use of interactive exercises, reflection questions, expert live chat and a final assessment at the end of the course.
Course Code: KPE-C-22
Course Title: KPE’s Certificate Program in Biologic (Biotech & Biosimilar) Regulation & Strategic Management
Course Objective: Working Professionals & B.Pharm/D.Pharm/ B.Sc/ Any graduates or those who are in 3rd / final year of those courses, who want to make career in biopharmaceutical marketing, business development and regulatory affairs, can pursue the course.
Nature of the Course: Distance & e-Learning
The course can be completed at any pace, allowing the user to stop and start at their leisure.
Features of the Course:
1. Comprehensive study material covering all important aspects of Biosimilar regulation.
2. Understanding/ Decision Making/ Strategy Creation in the field of Biosimilar regulation.
3. Live Pharma Case Study – File for easy understanding in biologics-biosimilar regulations and its implications.
4. Specialized modules on demand
5. Certificate will be issued at the end of the course.
1 Month
Section 1Introduction to Biopharmaceuticals
Lecture 1Introduction: Biopharmaceuticals
Lecture 2Classification & Detailed Understanding on Biopharmaceuticals
Lecture 3Introduction to Biologics and Biosimilar | Key differences | Concept of Reference Product
Lecture 4Chemical Drugs Vs. Biologic Drugs
Lecture 5Principle of Naming of Biologics
Lecture 6Moving Average | Moving Annual Total | YTD | How to calculate
Lecture 7Compound Annual Growth Rate | CAGR Calculation
Section 2Global Biopharmaceutical Market
Lecture 8Current Trends in Biopharmaceutical Market
Lecture 9Dynamics of Biopharmaceutical Market
Lecture 10Challenges of Biopharmaceutical Industry
Lecture 11Biopharmaceutical Market Segmentation
Lecture 12Blockbuster Biologic - Classifications, Indications, Global Sales
Section 3Detailed Understanding of different therapeutic classes of Biologics
Lecture 13Recombinant Proteins
Lecture 14Monoclonal Antibodies Vs. Polyclonal Antibodies
Lecture 15Monoclonal Antibodies : Detailed Understanding
Lecture 16Synthetic Immunomodulators
Lecture 17Production of Monoclonal Antibodies
Lecture 18Cytokines
Lecture 19Interferon
Lecture 20Erythropoiesis-stimulating agent (EPOs)
Section 4Biopharmaceutical Regulatory Approval Process
Lecture 21R&D Process & Introduction to discovery, development to commercialization process
Lecture 22Investigational New Drug Application
Lecture 23New Drug Application (NDA)
Lecture 24Biological Licensing Application (BLA) | 351(a) application | Form 356h | Differentiation with NDA | Timeline | Handling FDA queries
Lecture 25Basic concept and understanding of the Generic Drug
Lecture 26Abbreviated New Drug Application (ANDA) - Filing Requirement
Lecture 27Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
Lecture 28505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 29Purple Book: Significance | Searching | Assignments
Lecture 30Nomenclature of biosimilars
Lecture 31Vaccine development and approval Process
Lecture 32REMS Strategic Planning
Lecture 33PDUFA & BsUFA For Biologics
Lecture 34Clinical Trial - Advance Understanding
Lecture 35Advance Learning on 505B2 Pathway
Lecture 36FDA Forms and How to fill the resources
Lecture 37Chemistry, Manufacturing & Controls
Lecture 38Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !
Lecture 39Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE)
Lecture 40USFDA expedited programs for Biologic Approval
Lecture 41Orphan Drug Designation
Lecture 42Fundamental of CMC | Detailed understanding of CMC section writing | Important Points regarding CMC | Drug Product and Drug Substance | Excipient, FP, Analysis and Stability Study Requirements
Section 5Bio Manufacturing Process
Lecture 43Stages of Biosimilar development
Lecture 44Strategic Consideration for Biosimilar Development
Lecture 45Concept of Reference Biologics
Lecture 46Detailed Manufacturing Process
Lecture 47Concept of Interchangeability in Biosimilar Development
Lecture 48Studies required for approval of biosimilar
Lecture 49Demonstrating Biosimilarity: A More Complex Task
Lecture 50Difference between Bioreactor and Fermentor
Section 6Biopharmaceutical Patents - Biosimilar Entry / Exclusivity - Case Learnings
Lecture 51Introduction to intellectual Property Management
Lecture 52Patent
Lecture 53Scope of Patentability
Lecture 54Stages of Patent Grant Procedure
Lecture 55Steps Know How & Key Points - Patent Application
Lecture 56Differences in US and European Patent
Lecture 57Patent Claim | Types of Patent Claims
Lecture 58Patent Cliff | How to calculate the patent cliff
Lecture 59Patent Infringement
Lecture 60Introduction to Trademark | Trademark filing procedure
Lecture 61Trademark Searching Process | EUIPO Searching | USPTO Searching | IPINDIA Searching
Lecture 62Trademark Infringement | Passing off | Practical Cases
Lecture 63Trademark Classes | How to search the right trademark class for for filing trademark application
Section 7Principles for Development of Similar Biologics
Lecture 64Selection of Reference Biologics
Lecture 65Manufacturing Process Development for Biosimilar
Lecture 66Quality Based Considerations for Similar Biologics
Lecture 67Data Requirements for Preclinical Studies
Lecture 68Post-Market Data for Similar Biologics
Section 8Biosimilar Guidelines in Different Regions
Lecture 69WHO Regulatory Guidelines
Lecture 70European Union (EMA)
Lecture 71United States of America (US FDA)
Lecture 72Japan - PMDA
Lecture 73Korea (KFDA)
Lecture 74Canada (Health Canada)
Lecture 75China - SFDA
Lecture 76India (Central Drugs Standard Control Organization)
Lecture 77Jordan (Jordan Food and Drug Administration)
Lecture 78Middle East
Section 9Biosimilar Development to Commercialization : Case Studies
Lecture 79Biosimilar Development Timeline
Lecture 80Case Study New mAB approval: Avelumab for metastatic Merkel Cell Carcinoma (mMCC)
Section 10Biopharmaceutical Strategic Management
Lecture 81Patents Vs. exclusivity
Lecture 82Regulatory Strategies in different phases of Clinical Trial
Lecture 83Advance study on Para IV Filing
Lecture 84Para IV Notices
Lecture 85Evergreening - Patent Life Extension Strategies
Lecture 86Pay For Delay Strategy
Lecture 87In-Licensing Vs. Outlicensing
Lecture 88Leading Biologic Company's Analysis : Strategic Point of view
Lecture 89Strategic alliance Termination / Failure in strategic alliances in biopharmaceutical industry
Lecture 90Compulsory Licensing
Lecture 91Licensing & Technology Transfer
Lecture 92LOE Strategies for Innovator Brands with case study
Lecture 93Paediatric Exclusivity and Paediatric Study Plan Development
Lecture 94Drug Repurposing
Lecture 95Summary of Regulatory & Strategic Differences
Section 11Final Examination
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