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Research and Innovation Resource

Fundamental research

Discovery phase leading to Proof of concept

Three major classes of viral vectors

  • adenovirus (AD) (see: paper)  
  • adeno-associated virus (AAV) (see: paper)   
  • Lentivirus (see: paper)  

Gene editing tools

Pre-clinical model 

Good Laboratory Practice

Non-clinical development (safety and efficacy studies)  


Research on existing collections of samples  



Database for research 

Research on new collections of samples


Manufacturing phase  

Good manufacturing practices 

Chemistry Manufacturing Controls (CMC) 


Clinical Research

  • Guide on advanced therapy medicinal products - Clinical development flowchartEuropean Medicines Agency (EMA) 
  • NIHR Clinical Trials Toolkit, National Institute for Health Research (NIHR)
    • It is an interactive colour-coded routemap to help navigate through the legal and good practice arrangements surrounding setting up and managing a Clinical Trial of an Investigational Medicinal Product (CTIMP) 
  • ATMP Clinical Study guide, ATMP-Sweden

Clinical Trial 

Good Clinical Practice



ATMP certification procedure by CAT  


Intellectual Property rights   



Early interactions with regulators  


EMA- Innovation Task Force Briefing meetings

EMA- Scientific advice and Protocol Assistance  

Early support from national competent authorities 


Parallel advices (EMA/HTA, EMA/FDA) 


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