Educational objective

This training course aims to provide the technical knowledge necessary for the management of cell, gene and CAR-T therapy products, with the construction of a highly qualified professional figure.

The course will qualify operators with a constant comparison between the perspective of the sponsor and that of the center that infuses the cellular product.

 

 

How Educational Training is structured

The training course is structured in 4 modules plus a final test.

Once qualified, the learner will officially join the international register of Car-T Specialists and Gene Therapy Experts.

 

Module 1 – The Cellular Therapy Process and the legislation 27 September 2024

The first module aims to analyze the centre's compliance with current European and national legislation.

During the meeting, we will try to understand the nature of the cell therapy product, from a regulatory, procedural and organizational point of view.

The integration of the various regulations with GMP requirements will also be explored in depth and attention will be paid to the Regulation (EC) on advanced therapy medicinal products.

Then the role of the Cell Therapy and Car-T Specialist will be analyzed in the two job perspectives: sponsoring company and clinical center

Program

• What is Gene Therapy Product and CAR-T?
• Drug or Tissue?
• Production or Administration
• • The European and national reference legislation
    • the transfusion legislation
    • the legislation on fabrics
    • the GMPs
  • l Regulation (EC) 1394/2007 on advanced therapy medicinal products
    • The classification and evaluation of advanced therapy medicinal products within the centralized European procedure
    • The role of the European Medicines Agency and the Committee for Advanced Therapies (CAT)
    • Scope (and limits) of the hospital exemption (so-called hospital exemption)
    • Protection tools in the event of a negative opinion
    • The EMA's experience in evaluating CAR-Ts

   

   

  • The role of the Cell Therapy and Car-T Specialist from the perspective of the Clinical Center
  • The role of the Cell Therapy and Car-T Specialist from the Company's perspective

  Pharmaceutical

   

   

  Module 2 - The Organizational System 28 September 2024

  The second module of the Cell Therapy and Car-T Specialist qualification aims to analyze the problems relating to the design of an organizational system capable of complying with the mandatory regulatory requirements and the Sponsor's requirements. We will also propose a model of integration with the regulatory requirements and the concept of process validation will be illustrated.

   

  Program

  • How to design an organizational system in the Center
  • The process map
  • The documentary structure
  • The double integration of the document system: towards the company and towards

  towards the Sponsor

  • Validation and validation in the processes of a Cell Therapy Center
  • Integration of a HSC Transplant Program with a Cell Therapy Center:
  • Exercises with working groups

    Module 3 – The actors involved: critical issues and elements 4 October 2024

    The 3rd module aims to illustrate in detail the activities carried out by the various company functions involved in the cell therapy management process.

    The activities that each function performs in the process for cell product collection, manipulation and infusion will be analyzed.

    Program

    • The unit that performs cellular product collection
    • The cell manipulation laboratory and the Tissue Establishment
    • Cryopreserved and fresh starting material: advantages and disadvantages
    • The role of the pharmacy
    • Drug infusion by the clinical unit: important aspects and critical issues

     

    Module 4 – The qualification process 5 October 2024

    The 4th module focuses on the qualification process of the Center by the company

    sponsor and on the various subjects involved in the process.

    After having illustrated in detail the qualification process, the different phases and methods, the different subjects and the various functions that intervene directly or indirectly in the activity will be identified.

     

    Program

    • The qualification path
    • The main critical issues encountered
    • How to anticipate and overcome qualification non-conformities
    • The subjects who intervene in the process
    • The organizational chart and the internal and external organization of the centre