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  • Agile Management in Regulatory Affairs

Agile Management in Regulatory Affairs

Curriculum

  • 8 Sections
  • 24 Lessons
  • Lifetime
Expand all sectionsCollapse all sections
  • Module 1. Applying Agile Principles and Practices in the Pharmaceutical Project Management
    3
    • 1.0
      Lecture 1. Agile for Project Managers
    • 1.1
      Lecture 2. Where Can You Apply Agile in the Pharmaceutical Project Management
    • 1.2
      Lecture 3. How to Manage SCRUM-Like Meetings
  • Module 2. How to Manage International Projects
    3
    • 2.0
      Lecture 1. Why Do Companies Become International
    • 2.1
      Lecture 2. Challenges for Development Project Managers
    • 2.2
      Lecture 3. Practices for Managing International Projects
  • Module 3. How to Manage Drug–Device Projects
    3
    • 3.0
      Lecture 1. Establishing Regulatory Path
    • 3.1
      Lecture 2. Establishing the Project Plan
    • 3.2
      Lecture 3. Managing Drug Development vs Device Development
  • Module 4. Implementing Technology for Pharmaceutical Project Management
    3
    • 4.0
      Lecture 1. What Tools Do Project Managers Have
    • 4.1
      Lecture 2. Tools for Team Members
    • 4.2
      Lecture 3. The Future of Project Management Tools
  • Module 5. How to Assess, Select, and Implement a Project Management Information System
    6
    • 5.0
      Lecture 1. Assessing Requirements for Implementing a Project Management Solution
    • 5.1
      Lecture 2. What Is a Project?
    • 5.2
      Lecture 3. Templates
    • 5.3
      Lecture 4. Integrating Scheduling Directly with Resource Planning
    • 5.4
      Lecture 5. Effectiveness of a Transparent Data Flow
    • 5.5
      Lecture 6. Change Management
  • Module 6. How to Create an Asset Development Plan
    1
    • 6.0
      Lecture 1. What is an Asset Development Plan for a Project Manager
  • Module 7. How to Create a Clinical Development Plan
    3
    • 7.0
      Lecture 1. Creating CDP and dTPP
    • 7.1
      Lecture 2. Strategies for Developing Investigational and Trial Designs, Regulatory, and Operational Assumptions Plans
    • 7.2
      Lecture 3. Risk Assessment
  • Module 8. How to Create a Market Application Submission
    2
    • 8.0
      Lecture 1. Creating a MAS Plan Before TLR
    • 8.1
      Lecture 2. Creating a MAS Plan After TLR
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Lecture 1. Creating CDP and dTPP
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Lecture 3. Risk Assessment
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  • Courses
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    • Regulatory Affairs
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  • About
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    • Admissions and Studying
    • Reviews
    • Why study at LAI?
    • LAI Code of Ethics
  • Membership
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    • Psychology
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    • News & Updates
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