PROJECT
Study on Hospital Exemption in relation to the implementation of the Advanced Therapy Medicinal Products Regulation
A PROJECT FOR: European Health and Digital Executive Agency (HaDEA)
BRIEF
The
Challenge
The challenge of this project is rooted in the diverse interpretation and implementation of the Hospital Exemption (HE) rules across European Union (EU) Member States. The HE permits the use of Advanced Therapy Medicinal Products (ATMPs) in hospitals without full marketing authorization.
There are differences in the national HE rules and implementation of the HE across EU Member States. This project aims to gather evidence on how the HE functions in the EU Member States and will provide a comprehensive understanding of the role of HE within the Advanced Therapy Medicinal Products (ATMP) pathway.
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The overarching objective is to close the knowledge gaps, validate stakeholder perspectives, quantify the number of HE products, evaluate their accessibility and affordability, identify implementation barriers, establish best practices, and create a template for national implementation.
FOCUS
The
Approach
The project follows a structured approach to address the implementation of the Hospital Exemption (HE) in EU Member States.
This process includes creating an analytical framework through a literature review, engaging with stakeholders for data validation, preparing country reports, conducting surveys for evaluation, organizing a peer review for quality assurance, and ultimately delivering a final analysis report.
Additionally, a one-day stakeholders' meeting in Brussels will gather expert feedback to enhance the project's outcomes.
CONCLUSIONS
The Envisioned Result
The expected outputs of the study are: to garner a clear understanding of HE implementation and products in EU Member States, gain insights into the roles of stakeholders like university hospitals, provide a defined regulatory purpose for HE, and the provision of practical examples of best practices for HE implementation.
Partners Involved
We are collaborating with Intellera, CECOFORMA, and Empirica on this project.
PredictBy is responsible for multiple tasks in this project as an expert in PROJECT MANAGEMENT, INTERVIEWS, DESK RESEARCH,and DATA VALIDATION.
Our role in the project consists of conducting the following tasks:
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Literature review
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Search on websites
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In-depth analysis
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Design of the analytical framework
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Organisation of the peer review
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Public online survey
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Final report including the final analysis, recommendations/conclusions and the template for reporting
