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所在平台: Udemy |
课程主页: https://www.udemy.com/course/technical-project-management-for-generic-drug-development/
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本课程名为《通用药物开发的技术项目管理》，旨在帮助学员掌握通用药物开发过程中所需的项目管理技能与知识。课程内容涵盖以下几个主要部分： 1. **通用药物开发概述**：讲解活性药物成分（API）和成品药（FPP），参考列药（RLD）和通用药物的定义，以及药物的生物等效性等基本概念。 2. **项目管理基础**：介绍项目及其要素（成本、时间、范围），项目优先级、项目阶段、项目经理及其团队和利益相关者，并探讨项目管理工具的应用。 3. **通用药物开发的项目管理**：包括项目日记、里程碑、甘特图和执行阶段等。 4. **桌面研究**：强调在通用药物开发中进行文献查阅的重要性，以及相关机构如欧洲药品管理局（EMA）、世界卫生组织（WHO）和美国食品药品监督管理局（FDA）等的作用。 5. **原材料选择与预配方研究**：涵盖原材料评估、稳定性、供应商选择以及配方定义和兼容性研究。 6. **分析方法开发研究**：寻求和验证分析方法的过程，包括压力测试与预验证研究。 7. **配方研究与分析**：涉及实施配方试验、优化和分析配方以满足关键质量属性等。 8. **试点制造**：评价试点制造所需化学品和原材料，风险评估以及制造文档的准备。 9. **生物等效性研究**：涉及BE研究样本准备、执行和结果文档编制。 10. **注册文档的准备**：为药物注册准备相关文件并进行申请。 课程最后总结了通用药物开发的技术项目管理要点，帮助学员更好地理解药物开发过程中的项目管理各个环节。本课程适合希望在制药行业从事项目管理的专业人士。
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
