Introduction
Features
Duration
Content Deliverables
Course Syllabus
Admission Process
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
Course Description:This online course – KPE’s Certificate Program in Biologic (Biotech & Biosimilar) Regulation & Strategic Management training course utilizes interactive learning tools to guide each participant through the steps of the 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.
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 Modules
| 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.
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 Biosimilar
Lecture 4Chemical Drugs Vs. Biologic Drugs
Lecture 5Principle of Naming of Biologics
Section 2Global Biopharmaceutical Market
Lecture 6Current Trends in Biopharmaceutical Market
Lecture 7Dynamics of Biopharmaceutical Market
Lecture 8Challenges of Biopharmaceutical Industry
Lecture 9Biopharmaceutical Market Segmentation
Lecture 10Market Share of Different Class of Biopharmaceuticals
Lecture 11Blockbuster Biologic - Classifications, Indications, Global Sales
Section 3Detailed Understanding of different therapeutic classes of Biologics
Lecture 12Recombinant Proteins
Lecture 13Monoclonal Antibodies Vs. Polyclonal Antibodies
Lecture 14Monoclonal Antibodies : Detailed Understanding
Lecture 15Synthetic Immunomodulators
Lecture 16Production of Monoclonal Antibodies
Lecture 17Cytokines
Lecture 18Interferon
Lecture 19Erythropoiesis-stimulating agent (EPOs)
Section 4Biopharmaceutical Regulatory Approval Process
Lecture 20New Biopharmaceutical Approval process Vs. Bissimilar Vs. New Molecule Vs. Generic Drug Approval Process
Lecture 21Biologic License Application (BLA)
Lecture 22Biosimilar Approval process
Lecture 23Difference : Drugs Vs. Biopharmaceutical Approval process
Lecture 24Nomenclature of biosimilars
Lecture 25Vaccine Development Process
Lecture 26Pricing and cost effectiveness of biosimilars
Lecture 27Exclusivity Protections for Biopharmaceuticals
Lecture 28Risk Evaluation and Mitigation Strategy (REMS)
Lecture 29Learning from New Drug Approvals - 2016
Lecture 30PDUFA & BsUFA For Biologics
Lecture 31Review : 351(a) vs. 351(k) pathway
Lecture 32Advance Learning on 505B2 Pathway
Lecture 33FDA Forms and How to fill the resources
Lecture 34Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !
Section 5Bio Manufacturing Process
Lecture 35Stages of Biosimilar development
Lecture 36Challenges in manufacturing of biosimilar
Lecture 37Concept of Reference Biologics
Lecture 38Detailed Manufacturing Process
Lecture 39Concept of Interchangeability in Biosimilar Development
Lecture 40Studies required for approval of biosimilar
Lecture 41Demonstrating Biosimilarity: A More Complex Task
Lecture 42Difference between Bioreactor and Fermentor
Section 6Biopharmaceutical Patents - Biosimilar Entry / Exclusivity - Case Learnings
Lecture 43Practical Training on understanding of Biopharmaceutical Patent
Lecture 44Biopharmaceutical Exclusivity / protections
Lecture 45Patent Protection Small Molecules Vs. Innovator Biologics
Lecture 46Regulatory Exclusivity for Small Molecules Vs. Biosimilars
Lecture 47Steps Know How & Key Points - Patent Application
Lecture 48Fundamental Understanding of Patent, Trademark Licensing and related terminology
Section 7Principles for Development of Similar Biologics
Lecture 49Selection of Reference Biologics
Lecture 50Manufacturing Process Development for Biosimilar
Lecture 51Quality Based Considerations for Similar Biologics
Lecture 52Data Requirements for Preclinical Studies
Lecture 53Post-Market Data for Similar Biologics
Section 8Biosimilar Guidelines in Different Regions
Lecture 54WHO Regulatory Guidelines
Lecture 55European Union (EMA)
Lecture 56United States of America (US FDA)
Lecture 57Japan - PMDA
Lecture 58Korea (KFDA)
Lecture 59Canada (Health Canada)
Lecture 60China - SFDA
Lecture 61India (Central Drugs Standard Control Organization)
Lecture 62Jordan (Jordan Food and Drug Administration)
Lecture 63Middle East
Section 9Biosimilar Development to Commercialization : Case Studies
Lecture 64Biosimilar Development Timeline
Lecture 65Case Study New mAB approval: Avelumab for metastatic Merkel Cell Carcinoma (mMCC)
Section 10Biopharmaceutical Strategic Management
Lecture 66Patents Vs. exclusivity
Lecture 67Regulatory Strategies in different phases of Clinical Trial
Lecture 68Advance study on Para IV Filing
Lecture 69Para IV Notices
Lecture 70Evergreening - Patent Life Extension Strategies
Lecture 71Pay For Delay Strategy
Lecture 72In-Licensing Vs. Outlicensing
Lecture 73Leading Biologic Company's Analysis : Strategic Point of view
Lecture 74Strategic alliance Termination / Failure in strategic alliances in biopharmaceutical industry
Lecture 75Compulsory Licensing
Lecture 76Licensing & Technology Transfer
Lecture 77LOE Strategies for Innovator Brands with case study
Lecture 78Paediatric Exclusivity and Paediatric Study Plan Development
Lecture 79Drug Repurposing
Lecture 80Summary of Regulatory & Strategic Differences
Section 11Final Examination
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