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    • Welcome to the INSAFEDARE Academy

      The INSAFEDARE Academy is the official online learning platform of the Horizon Europe project INSAFEDARE (Innovative Applications of Assessment and Assurance of Data and Synthetic Data for Regulatory Decision Support).

      The platform provides open educational resources and certification opportunities on:

      • Digital Health and Medical Device Regulation
      • Real-World and Synthetic Health Data
      • Artificial Intelligence in Healthcare
      • Data Quality, FAIR Principles and Interoperability
      • Regulatory Decision Support and Validation Frameworks

      Training Programme: "Regulatory Decision-Making in Digital Health and Medical Devices"

      The objective of the programme is to support researchers, healthcare professionals, medical device manufacturers, notified bodies, regulators, and students in developing competencies for the safe and effective use of health data and AI technologies in regulatory environments. Also, to enable manufactures, healthcare and regulatory professionals to competently design, assess, interpret, and use real-world and synthetic health data for medical device regulation, in alignment with EU legal, ethical, and quality requirements.

      Learning Pathway

      1. Complete Module 1 – Fundamental Understanding and Principles
      2. Continue with one or more stakeholder-specific modules
      3. Obtain your certificate of completion

    • The INSAFEDARE project receives funding under the European Union's Horizon Europe Research and Innovation Programme under grant agreement No. 101095661. The contents of this website do not necessarily reflect the position of the European Commission and the European Commission is not responsible for any use that may be made of the information it contains.

Available courses

Module 1 – Fundamental Understanding and Principles
INSAFEDARE Syllabus
Module 1 – Fundamental Understanding and Principles
Module 2 – Medical Device Manufacturers
INSAFEDARE Syllabus
Module 2 – Medical Device Manufacturers

Prerequisite: Successful completion of Module 1 – Fundamental Understanding and Principles is required in order to complete this stakeholder-specific training module and obtain the corresponding certificate.

Module 3 – Notified Bodies and Regulators
INSAFEDARE Syllabus
Module 3 – Notified Bodies and Regulators

Prerequisite: Successful completion of Module 1 – Fundamental Understanding and Principles is required in order to complete this stakeholder-specific training module and obtain the corresponding certificate.

Module 4 – Independent Technical Assessors
INSAFEDARE Syllabus
Module 4 – Independent Technical Assessors

Prerequisite: Successful completion of Module 1 – Fundamental Understanding and Principles is required in order to complete this stakeholder-specific training module and obtain the corresponding certificate.

Module 5 – Data Analysts and Healthcare Professionals
INSAFEDARE Syllabus
Module 5 – Data Analysts and Healthcare Professionals

Prerequisite: Successful completion of Module 1 – Fundamental Understanding and Principles is required in order to complete this stakeholder-specific training module and obtain the corresponding certificate.