General information

Advanced Therapy Medicinal Products (ATMPs), are medicines for human use based on genes, cells or tissue engineering. They represent one of the biggest changes in health care since the introduction of cell transplantations and their many refinements over the last 50 years.

In haematology, the most widely known group of ATMPs are gene therapy medicinal products (GTMPs) such as Immune Effector Cells (IECs). CAR-T (Chimeric Antigen Receptor T-cell), a type of IEC, is the most familiar product currently with many centres across Europe either recently or planning to deliver CAR-T alongside established hematopoietic stem cell transplantation. There are also somatic cell therapy medicinal products (sCTMPs), tissue engineered products (TEPs) and combined ATMPs (cATMPs).

The delivery of ATMPs involves a complex supply chain. The supply chain is the network of all the individuals, organizations, resources, activities and technology involved in the creation of a product. For ATMPs, supply chain needs to combine unique requirements derived from pharmaceutical rules for aseptic manufacturing of medicinal products on one hand, and on-demand manufacturing of single personalized batches of a medicinal product that is essentially made of cryopreserved human living cells. Although ATMPs (like CAR-T cells) can be considered as rationally-developed targeted therapies, they can trigger serious and potentially life-threatening complications.
 
As nurses, this change is accompanied with additional training needs that range from basic to advanced depending on centre and country experience. The EBMT Nurses Group is conducting a survey to identify information about member countries training needs for ATMPs, the most common currently being CAR-T therapy, with many other products expected to be in use over the next decade.

This initial survey is being distributed Europe-wide and findings will provide an overview of current training needs and inform the development of subsequent training materials and support, such as e-learning materials and workshops.
 
Please note
Your responses should reflect your own/your own centre experiences. You are not responding on behalf of your country.

This survey will take 20 minutes to complete.
 

We thank the Midlands-Wales Advanced Therapy Treatment Centre (MW-ATTC) for sharing a training needs analysis survey which was useful in the development of this work.
 

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* 1. EBMT membership CIC number of hospital (only the number)

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* 2. Your contact information

The personal data provided above will be processed solely to gather information on nurse ATMP training needs in EBMT Centres and according to the General Data Protection Regulation (GDPR 2016/679). The personal data will be incorporated to a database property of EBMT. Data Subjects have the right of access, rectification, erasure, restriction, data portability and objection to the processing of his or her personal. If as a data subject you would like to exercise any of the rights listed above please write to Anne Lippinkhof at EBMT_NursesGroup@lumc.nl. For further information please go to the Privacy Policy.

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* 3. Is your centre JACIE accredited?

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* 4. Do you work in an academic centre?

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* 5. With which patients do you work?

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* 6. What is your current practice area? (Please tick all that apply)

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* 7. What is your current role?

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* 8. How many years of experience do you have in haematology or bone marrow transplantation?

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* 9. What is your personal level of experience in delivering advanced therapies (ATMPs)?

  Experienced Some None Don't know
‘Unlicensed’ products delivered in the context of clinical trial
Licensed products

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* 10. Do you deliver ATMPs (such as CAR-T cells) at your centre?

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* 11. Do you follow-up patients who have received ATMPs (such as CAR-T cells) at another centre?

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