This course is designed exclusively to impart Induction Training for biopharmaceutical professionals working in sales department.
Maximum Access Duration: 1 Month
Core Learning Areas
- Basics of Biopharmaceuticals.
- R&D Fundamentals
- Understanding on various classes of the Biopharmaceuticals.
- Concepts of Biosimilar / Similar Biologics
- Development and Approval Pathways Biosimilars
- Selling skill training for Medical Representatives
Methodology: Login with your user id and password and access the course step by step.
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Corporate Training: Specialized designed for the employees of Celltrion Healthcare.
Usage Restricted to Celltrion Employees Only !
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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
Lecture 12Market Understanding: Leading Biosimilar Companies
Lecture 13Market Understanding: Top Leading Brands
Section 3Detailed Understanding of different therapeutic classes of Biologics
Lecture 14Recombinant Proteins
Lecture 15Monoclonal Antibodies Vs. Polyclonal Antibodies
Lecture 16Monoclonal Antibodies : Detailed Understanding
Lecture 17Synthetic Immunomodulators
Lecture 18Production of Monoclonal Antibodies
Lecture 19Cytokines
Lecture 20Interferon
Lecture 21Erythropoiesis-stimulating agent (EPOs)
Section 4Biopharmaceutical Regulatory Approval Process
Lecture 22R&D Process & Introduction to discovery, development to commercialization process
Lecture 23Investigational New Drug Application
Lecture 24Biological Licensing Application (BLA) | 351(a) application | Form 356h | Differentiation with NDA | Timeline | Handling FDA queries
Lecture 25Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
Lecture 26Purple Book: Significance | Searching | Assignments
Lecture 27Nomenclature of biosimilars
Lecture 28Vaccine development and approval Process
Lecture 29REMS Strategic Planning
Lecture 30Clinical Trial - Advance Understanding
Section 5Bio Manufacturing Process
Lecture 31Fundamental understanding in Biosimilar development
Lecture 32Strategic Consideration for Biosimilar Development
Lecture 33Detailed Manufacturing Process
Lecture 34Concept of Interchangeability in Biosimilar Development
Lecture 35Studies required for approval of biosimilar
Lecture 36Demonstrating Biosimilarity: A More Complex Task
Section 6Biosimilar Development to Commercialization : Case Studies
Lecture 37Biosimilar Development Timeline
Lecture 38Case Study New mAB approval: Avelumab for metastatic Merkel Cell Carcinoma (mMCC)
Section 7Selling Skill Training
Lecture 39What is Biopharma Selling? Definition and Fundamental Understanding
Lecture 40Growth Path / Career for Pharma Sales professionals
Lecture 41Qualities of Dynamic Sales Person
Lecture 42Job Description of Medical Representatives
Lecture 43Sales Territory Planning
Lecture 44Doctor List Preparation | SVL | MSL | Call Average | Call Frequency | Missed call analysis | Doctor Territory Matrix | Call Average | Day Wise work Plan
Lecture 45Understanding Sales Process | Call Planning | Pre-call Planning Process
Lecture 46Retail Chemist Prescription Audit - RCPA
Lecture 47Concept of Vital 3 Minutes | Understanding Prescribing Motives | Call Objective Setting
Lecture 48In Clinic Performance | Guideline | Dos and Don’ts | Detailing Talk
Lecture 49Advance Concept - Total Practice Call (TPC) |Pharma Brand Building Ladder (PPBL) | Top of Mind
Lecture 50Probable Reason for unsuccessful calls
Lecture 51Post Call Analysis
Lecture 52Preparing Checklist before sales call
Lecture 53Key Performance Indicator For Medical Representative Job
Lecture 54Simulation: Inclinic Performance [134.1]
Lecture 55Classification of Doctors
Lecture 56Types of Doctors and Physician
Lecture 57Medical Degrees
Lecture 58How to deal with rejection | A must have skill for outperforming sales professionals | Dealing with tough situation
Lecture 59Competency Development Test
