Introduction
Features
Duration
Content Deliverables
Course Syllabus
Admission Process
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:Â 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
Course Content Deliverables:
1. Printable Module can be downloaded by visiting to your dashboard.
2. Access the E-Modules online with user id and password.
3. Attend e-lectures.
4. Access to case study file online
5. All e-study material contains self assessment computer based test.
6. Flexible online final examination.
Printable ModulesÂ
| Module 1 | Drug Discovery and Development Process |
| Module 2 | Biopharmaceutical – Detailed Understanding |
| Module 3 | Biosimilar |
| Module 4 | Biosimilar Development Process |
| Module 5 | Biopharmaceutical Industry |
| Module 6 | EU Biosimilar guidelines |
| Module 7 | Biosimilar guidelines in different regions |
| Module 8 | Licensing and Technology Transfer in Biopharmaceutical Industry |
| Module 9 | Biopharma Case Studies |
Other than books, you will also get the online modules – electures, case studies etc. which you can access by login with your access credentials.Â
Biologic & Biosimilar Regulation and Registration course is structured as follows:
- Biotech Drug Development Process
Overview of the development of a biotech product – clarify the difference between synthetic drugs, biologics and biotech products . - Biotech Regulation – Key Understanding
US drugs vs. Biologics Law: Understand the differences in regulatory philosophy between small molecules and biotech product regulation - Preclinical and Clinical Research Design
An examination of preclinical and clinical research designs. Emphasis is on identifying and addressing challenges associated with elements of good laboratory and clinical practice and qualifying and managing a laboratory for a clinical trial. Discussion covers best practices for planning research and collecting, analyzing, and reporting data from drug/device development studies. - Analytical techniques for the Biotech Drugs
Understand the need for using a range of analytical methods in the characterization of biotech product. - Product Life Cycle Approval, Production, and Marketing for Bio-pharmaceuticals
An in-depth study of the product life cycle for biopharmaceuticals. Focus is on the various stages within the life cycle from conceptualization of a product pipeline in research and development through postmarket surveillance and production. Topics include regulatory submission, approval, production, and the postmarket environment for both drugs and devices. Challenges surrounding the approval and naming of follow-on biologics are addressed. Discussion also covers combination medicines, the stages of a drug pipeline and risk assessment at each stage, and the decreasing productivity of the drug pipeline. The role of a contract research organization in testing and approval is explained, and the nature of the support services they provide to the biotechnology and devices industry is explored. - Global Biotechnology Business
Topics include international biotechnology issues, global harmonization efforts, and the cultural impact of biotechnologies. Discussion also covers domestic and International business considerations and international regulatory requirements.
Practical Case Studies – Applications of Biotech Regulatory Affairs
A capstone study of regulatory affairs related to the biotechnology industry that integrates knowledge and skills gained from previous study.
- Introduction to Global biopharmaceutical Industry. Overview of General Regulation.
- Biotech Drug Discovery and Development Process
- Biotech Drugs Classification. Important classes.
- Introduction to Biotech Industry – Global and Indian. Leading Biotech companies and their product and pipeline analysis
- Regulation in Biotech Industry
- Overview of patent in biotech industry.
- Introduction to Biosimilar. Meaning of Biosimilar vs. Follow on biologics.
- Difference between biosimilar and generic drugs.
- Key important issues in Biotech and biosimilar product manufacturing.
- GMP requirements in biotech industry.
- General approval process of biosimilar products.
- Biosimilar Development project management – timeline creation with business outcome
Country specific regulation in Biosimilar Products –
- Biotech and Biosimilar regulation in US
- Biotech and Biosimilar regulation in EU
- Major differences in US and EU
- Biosimilar regulation and registration in India
- Biosimilar policies in the UK, Use of biosimilars in Europe, EMEA regulation on biosimilar
- Registration of biosimilar in other different countries
Course Flow and Timeline
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 calculateÂ
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)Â
Lecture 24Biological Licensing Application (BLA)Â | 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)Â - 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 PlanningÂ
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 & ControlsÂ
Lecture 38Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !
Lecture 39Learning from New Drug Approvals
Lecture 40Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE)Â
Lecture 41USFDAÂ expedited programs for Biologic Approval
Section 5Bio Manufacturing Process
Lecture 42Stages of Biosimilar development
Lecture 43Strategic Consideration for Biosimilar DevelopmentÂ
Lecture 44Concept of Reference Biologics
Lecture 45Detailed Manufacturing Process
Lecture 46Concept of Interchangeability in Biosimilar Development
Lecture 47Studies required for approval of biosimilar
Lecture 48Demonstrating Biosimilarity: A More Complex TaskÂ
Lecture 49Difference between Bioreactor and Fermentor
Section 6Biopharmaceutical Patents - Biosimilar Entry / Exclusivity - Case Learnings
Lecture 50Practical Training on understanding of Biopharmaceutical Patent
Lecture 51Biopharmaceutical Exclusivity / protections
Lecture 52Patent Protection Small Molecules Vs. Innovator Biologics
Lecture 53Regulatory Exclusivity for Small Molecules Vs. Biosimilars
Lecture 54Steps Know How & Key Points - Patent Application
Lecture 55Fundamental Understanding of Patent, Trademark Licensing and related terminology
Section 7Principles for Development of Similar Biologics
Lecture 56Selection of Reference Biologics
Lecture 57Manufacturing Process Development for Biosimilar
Lecture 58Quality Based Considerations for Similar Biologics
Lecture 59Data Requirements for Preclinical Studies
Lecture 60Post-Market Data for Similar Biologics
Section 8Biosimilar Guidelines in Different Regions
Lecture 61WHO Regulatory Guidelines
Lecture 62European Union (EMA)
Lecture 63United States of America (US FDA)
Lecture 64Japan - PMDA
Lecture 65Korea (KFDA)
Lecture 66Canada (Health Canada)
Lecture 67China - SFDA
Lecture 68India (Central Drugs Standard Control Organization)
Lecture 69Jordan (Jordan Food and Drug Administration)
Lecture 70Middle East
Section 9Biosimilar Development to Commercialization : Case Studies
Lecture 71Biosimilar Development Timeline
Lecture 72Case Study New mAB approval: Avelumab for metastatic Merkel Cell Carcinoma (mMCC)
Section 10Biopharmaceutical Strategic Management
Lecture 73Patents Vs. exclusivity
Lecture 74Regulatory Strategies in different phases of Clinical Trial
Lecture 75Advance study on Para IV Filing
Lecture 76Para IV Notices
Lecture 77Evergreening - Patent Life Extension Strategies
Lecture 78Pay For Delay Strategy
Lecture 79In-Licensing Vs. Outlicensing
Lecture 80Leading Biologic Company's Analysis : Strategic Point of view
Lecture 81Strategic alliance Termination / Failure in strategic alliances in biopharmaceutical industry
Lecture 82Compulsory Licensing
Lecture 83Licensing & Technology Transfer
Lecture 84LOE Strategies for Innovator Brands with case study
Lecture 85Paediatric Exclusivity and Paediatric Study Plan Development
Lecture 86Drug Repurposing
Lecture 87Summary of Regulatory & Strategic Differences
Section 11Final Examination
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