Introduction to Health Technology Assessment (HTA) of Medical Devices and IVDs

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• Select section General

  General

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  After completing this course, you will be able to:

  • Acquire knowledge about the Health Technology Assessment (HTA) principles in Medical Devices and in vitro diagnostics (IVDs)
  • Understand key definitions about HTA in Medical Devices
  • Acquire knowledge about the EU regulatory framework of HTA and the correlation with Medical Devices
  • Learn about the HTA methodologies, including the HTA core model
  • Understand about clinical effectiveness and Evidence generation for HTA
  • Acquire knowledge about the patient involvement in HTA in the context of Medical Devices

   

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• Select section Lesson 1: Introduction to Health Technology Assessment (HTA) of Medical Devices and IVDs

  Lesson 1: Introduction to Health Technology Assessment (HTA) of Medical Devices and IVDs

  • Select activity 1. Introduction

    

    1. Introduction Page

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  • Select activity 2. Definitions

    

    2. Definitions Page

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• Select section Lesson 2: New EU Regulation on HTA (Regulation (EU) 2021/2282)

  Lesson 2: New EU Regulation on HTA (Regulation (EU) 2021/2282)

  • Select activity 1. Introduction

    

    1. Introduction Page

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  • Select activity 2. Principles of the EU HTA regulation

    

    2. Principles of the EU HTA regulation Page

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  • Select activity 3. Key elements of the HTA regulation

    

    3. Key elements of the HTA regulation Page

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• Select section Lesson 3: HTA Methodologies

  Lesson 3: HTA Methodologies

  • Select activity 1. Introduction

    

    1. Introduction Page

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  • Select activity 2. HTA Core Model

    

    2. HTA Core Model Page

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  • Select activity 3. Clinical effectiveness and evidence generation for HTA

    

    3. Clinical effectiveness and evidence generation for HTA Page

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  • Select activity 4. Additional aspects

    

    4. Additional aspects Page

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• Select section Lesson 4: Patient contribution/involvement

  Lesson 4: Patient contribution/involvement

  • Select activity 1. Introduction

    

    1. Introduction Page

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  • Select activity 2. Setting

    

    2. Setting Page

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  • Select activity 3. Patient and social aspects

    

    3. Patient and social aspects Page

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  • Select activity 4. Non-comprehensive list of aspects for patient involvement in HTA of Medical Devices

    

    4. Non-comprehensive list of aspects for patient involvement in HTA of Medical Devices Page

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  • Select activity 5. Conclusions on HTA for Medical Devices and IVDs

    

    5. Conclusions on HTA for Medical Devices and IVDs Page

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• Select section Assessment

  Assessment

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