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所在平台: Udemy |
课程主页: https://www.udemy.com/course/drug-development/
课程评论：没有评论
《药物研发及制药研发业务框架》课程总结 此课程为有志于进入生物制药行业的个人，或药物研发领域的新入职员工、非技术背景人员提供了一个全面的药物开发流程概览。课程内容涵盖从新药发现到监管提交的各个环节，并深入探讨团队结构、项目管理框架、治理与报告机制。通过本课程的学习，学员将能够更熟悉并自信地在生物制药公司工作或与之合作。 **课程亮点：** * **核心流程理解：** 深入理解药物研发的关键步骤，特别是各个开发阶段的重点。 * **商业与运营视角：** 掌握药物研发项目的管理及其业务和运营层面的考量。 * **职责清晰：** 了解研发职能部门和项目团队在整个药物开发过程中的具体职责。 **学习目标：** * 夯实药物开发流程的基础知识，并识别生物制药公司中的主要角色。 * 准确识别药物开发过程中的关键步骤。 * 了解参与药物开发的关键职能部门。 * 识别药物开发项目的关键决策点、阶段、工作包和可交付成果。 **关键收获：** * **药物开发阶段：** 从发现、临床开发到最终提交的完整流程。 * **临床开发：** 临床试验的一般原则及不同阶段的特点。 * **全球药物开发计划与目标药品剖面 (TPP)：** 理解其重要性。 * **研发职能职责：** 涵盖化学、制造与控制 (CMC)、项目管理、法规事务、临床、非临床开发等关键职能部门的角色与责任。 * **项目管理框架：** 熟悉现代制药研发的项目阶段、里程碑和治理体系。 **目标受众：** * 药物开发和临床研究领域的新晋专业人士。 * 希望更深入理解药物开发项目推动的商业和运营方面的科学及非科学背景员工。 * 任何对药物开发流程感兴趣的学习者。
Are you considering a career in the biopharmaceutical industry? Are you a new employee or non-technical person working in Pharmaceutical R & D?About This CourseThis course will provide you with an overview of the whole Drug Development process, from drug discovery to regulatory submission, with insights into team structure, project management framework, governance & reporting. In essence, the course will provide you with the assets to be familiarised and make you more comfortable working for or with a biopharma company.Why You Should JoinTo improve the understanding of the essential steps in drug development process with focus on the development stagesUnderstand the business and operational aspects of managing drug development projectsUnderstand the responsibilities of R & D functions' and project teams along the drug development processLearning ObjectivesBy the end of this course, you will:Get a solid foundation in the drug development process and who are major actors in a biopharma companyIdentify the essential steps in the drug development process Identify the key functions involved in the drug development process Recognise the key decision points, phases, workpackages and deliverables in a drug development projectKey Take AwaysDrug Development phases from discovery, through clinical development to submissionClinical Development: general principles of clinical trials and phase specificitiesThe Global Drug Development Plan and the Target Product Profile (TPP) and their importanceRoles and responsibilities of R & D Functions (Chemistry, Manufacturing, and Controls, Project Management, Regulatory Affairs, Clinical, Non-Clinical Development)Project Management framework for modern pharmaceutical development: Project phases, milestones, governanceTarget AudienceProfessionals new to drug development and clinical research Scientific and non-scientific employee eager to better understand business and operational aspects of driving drug development projectsAnybody interested in learning more about the drug development process
