Technical Project Management For Generic Drug Development

What you'll learn
Introduce to Project Management
Learn Generic Drug Development
Understand Desk Research for Generic Drug Development
Learn Raw Material Selection for Generic Drug Development
Learn Pre-Formulation Studies for Generic Drug Development
Understand Analytical Method Development Studies for Generic Drug Development
Discuss Formulation Studies for Generic Drug Development
Learn Pilot Manufacturing for Generic Drug Development
Understand Bioequivalency Study for Generic Drug Development
Learn Registration Dossier for Generic Drug Development
Requirements
Require mobile/tablet/laptop/personal computer with internet
To be student, graduate and/or professional in related disciplines
Description
COURSE CONTENT 1 Introduction 2 Introduction to Generic Drug Development 2.1. Active Pharmaceutical Ingredient (API) & Finished Pharmaceutical Product (FPP) 2.2. Reference Listed Drug (RLD) & Generic (Multisource) Pharmaceutical Products 2.3. Pharmaceutical Bioequivalency (Therapeutic Equivalency) 2.4. Reference Listed Drug (RLD) Development 2.5. Generic Drug Development 2.6. Comparision of Reference Listed Drug (RLD) Development & Generic Drug Development 2.7. In-vitro & In-vivo Studies for Drug Product 3 Introduction to Project Management 3.1. Project & Elements of Project (Cost, Time, Scope) 3.2. Priorizitation of Project (Pipeline) 3.3. Project Phases 3.4. Project Manager 3.5. Project Team & Project Stakeholders 3.6. Project Management Tools 4 Project Management for Generic Drug Development 4.1. Project Diary for Generic Drug Development 4.2. Project Milestones for Generic Drug Development 4.3. Project Gantt Chart for Generic Drug Development 4.4. Generic Drug Development Project Phases (Execution Phase) 5 Desk Research for Generic Drug Development 5.1. Desk Research for Generic Drug Development 5.2. European Medicines Agency (EMA) 5.3. World Health Organization (WHO) & Food and Drug Administration (FDA) 5.4. Pharmacopoeias & Dailymed 5.5. Drugscom 5.6. DrugBank 5.7. Google Patents 5.8. Espacenet 6 Raw Material Selection for Generic Drug Development 6.1. Raw Material Selection for Generic Drug Development 6.2. Evaluation of Characteristics of API 6.3. Evaluation of Stability Characteristics of API 6.4. Evaluation of Suppliers of API 6.5. Evaluation of Inactive Ingredient and Packaging Material 7 Pre-Formulation Studies for Generic Drug Development 7.1. Pre-Formulation Studies for Generic Drug Development 7.2. Characterization of RLD 7.3. Defining Quality Target Product Profile (QTPP) 7.4. Evaluation of BE Requirements 7.5. Evaluation of Inactive Ingredient Required for Formula 7.6. Compatibility Study 7.7. Supplying New material / Apparatus / Equipment 7.8. Performing Pre-Formulation Trials 8 Analytical Method Development Studies for Generic Drug Development 8.1. Analytical Method Development Studies for Generic Drug Development-1 8.2. Analytical Method Development Studies for Generic Drug Development-2 8.3. Literature Search for Analytical Method Development 8.4. Supplying Chemicals / Materials / Equipments 8.5. Performing Method Development Studies 8.6. Determining Acceptance Criteria 8.7. Determining Dissolution Parameters 8.8. Performing Stress Studies 8.9. Performing Pre-Validation Studies 9 Formulation Studies for Generic Drug Development 9.1. Formulation Studies for Generic Drug Development 9.2. Performing Formulation Trials 9.3. Optimizing Formulation by using QBD 9.4. Supplying Chemicals / Raw-Materials / Equipments for Pilot Manufacturing 9.5. Preparing Formulations for Critical Material Attributes (CMA) 9.6. Preparing Formulations for Critical Quality Attribute (CQA) 9.7. Preparing Formulations for Critical Process Parameter (CPP) 9.8. Discriminitive Dissolution Parameters 9.9. Compatibility Study with Final Formula / Components 10 Analytical Studies for Generic Drug Development 10.1. Validation of Analytical Methods 10.2. Evaluation Bulk and Product Characteristic / Performance 10.3. Comparision Test Product with RLD In-vitro Conditions 10.4. Performing Analysis of Formulations for Critical Material Attributes (CMA) 10.5. Performing Analysis of Formulations for Critical Quality Attribute (CQA) 10.6. Performing Analysis of Formulations for Critical Process Parameter (CPP) 10.7. Performing Analysis of Formulations for for Discrimitive Dissolution Parameters 10.8. Performing Analysis of Formulations for Compatibility Study with Final Formula / Components 11 Pilot Manufacturing for Generic Drug Development 11.1. Evaluation of Chemicals / Raw-materials / Equipments used for Pilot Manufacturing 11.2. Performing Risk Assesment for Pilot Manufacturing 11.3. Performing Quality Procedures for Pilot Manufacturing 11.4. Documentation for Pilot Manufacturing 11.5. Manufacturing of Pilot Batches 12 Analysis of Pilot Batches for Generic Drug Development 12.1. Analysis of Chemicals / Raw-Materials used for Pilot Manufacturing 12.2. Analysis of Pilot Batches 12.3. Comparision Pilot Batches with RLD in In-vitro Conditions 12.4. Determining of BE Batches 13 Performing Bioequivalency Study for Generic Drug Development 13.1. Preparing Documentation for In-vitro Test Results 13.2. Preparation of Samples for BE Studies 13.3. Performing BE Studies 13.4. Documentating of BE Results 14 Preparation Registration Dossier for Generic Drug Development 14.1. Preparation of Registration Dossier 14.2. Performing of Registration Application 15 Conclusion
Overview
Section 1: Introduction
Lecture 1 Introduction
Section 2: Introduction to Generic Drug Development
Lecture 2 Active Pharmaceutical Ingredient (API) & Finished Pharmaceutical Product (FPP)
Lecture 3 Reference Listed Drug (RLD) & Generic (Multisource) Pharmaceutical Products
Lecture 4 Pharmaceutical Bioequivalency (Therapeutic Equivalency)
Lecture 5 Reference Listed Drug (RLD) Development
Lecture 6 Generic Drug Development
Lecture 7 Comparision of Reference Listed Drug (RLD) Development & Generic Drug Developmen
Lecture 8 In-vitro & In-vivo Studies for Drug Product
Section 3: Introduction to Project Management
Lecture 9 Project & Elements of Project (Cost, Time, Scope)
Lecture 10 Priorizitation of Project (Pipeline)
Lecture 11 Project Phases
Lecture 12 Project Manager
Lecture 13 Project Team & Project Stakeholders
Lecture 14 Project Management Tools
Section 4: Project Management for Generic Drug Development
Lecture 15 Project Diary for Generic Drug Development
Lecture 16 Project Milestones for Generic Drug Development
Lecture 17 Project Gantt Chart for Generic Drug Development
Lecture 18 Generic Drug Development Project Phases
Section 5: Desk Research for Generic Drug Development
Lecture 19 Desk Research for Generic Drug Development
Lecture 20 European Medicines Agency (EMA)
Lecture 21 World Health Organization (WHO) & Food and Drug Administration (FDA)
Lecture 22 Pharmacopoeias & Dailymed
Lecture 23 Drugs.com
Lecture 24 DrugBank
Lecture 25 Google Patents
Lecture 26 Espacenet
Section 6: Raw Material Selection for Generic Drug Development
Lecture 27 Raw Material Selection for Generic Drug Development
Lecture 28 Evaluation of Characteristics of API
Lecture 29 Stability Characteristics of API
Lecture 30 Evaluation of Suppliers of API
Lecture 31 Evaluation of Inactive Ingredient and Packaging Material
Section 7: Pre-Formulation Studies for Generic Drug Development
Lecture 32 Pre-Formulation Studies for Generic Drug Development
Lecture 33 Characterization of RLD
Lecture 34 Defining Quality Target Product Profile (QTPP)
Lecture 35 Evaluation of BE Requirements
Lecture 36 Evaluation of Inactive Ingredient Required for Formula
Lecture 37 Compatibility Study
Lecture 38 Supplying New material / Apparatus / Equipment
Lecture 39 Performing Pre-Formulation Trials
Section 8: Analytical Method Development Studies for Generic Drug Development
Lecture 40 Analytical Method Development Studies for Generic Drug Development - 1
Lecture 41 Analytical Method Development Studies for Generic Drug Development - 2
Lecture 42 Literature Search for Analytical Method Development
Lecture 43 Supplying Chemicals / Materials / Equipments
Lecture 44 Performing Method Development Studies
Lecture 45 Determining Acceptance Criteria
Lecture 46 Determining Dissolution Parameters
Lecture 47 Performing Stress Studies
Lecture 48 Performing Pre-Validation Studies
Section 9: Formulation Studies for Generic Drug Development
Lecture 49 Formulation Studies for Generic Drug Development
Lecture 50 Performing Formulation Trials
Lecture 51 Optimizing Formulation by using QBD
Lecture 52 Supplying Chemicals / Raw-Materials / Equipments for Pilot Manufacturing
Lecture 53 Preparing Formulations for Critical Material Attributes (CMA)
Lecture 54 Preparing Formulations for Critical Quality Attribute (CQA)
Lecture 55 Preparing Formulations for Critical Process Parameter (CPP)
Lecture 56 Discriminitive Dissolution Parameters
Lecture 57 Compatibility Study with Final Formula / Components
Section 10: Analytical Studies for Generic Drug Development
Lecture 58 Analytical Studies for Generic Drug Development
Section 11: Pilot Manufacturing for Generic Drug Development
Lecture 59 Pilot Manufacturing for Generic Drug Development
Section 12: Analysis of Pilot Batches for Generic Drug Development
Lecture 60 Analysis of Pilot Batches for Generic Drug Development
Section 13: Performing Bioequivalency Study for Generic Drug Development
Lecture 61 Performing Bioequivalency Study for Generic Drug Development
Section 14: Preparation Registration Dossier for Generic Drug Development
Lecture 62 Preparation Registration Dossier for Generic Drug Development
Section 15: Conclusion
Lecture 63 Conclusion
Learners who desire to take a part in Pharmaceutical Industry,Existing pharma professionals who are looking to progress in their jobs,Anyone who is looking to get entry in pharmaceutical industry




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