Multiprofessional Care Integration Challenges
October 15th 2021 - November 8th 2021
Susana Roncon (MD)
In recent times, the production of advanced therapy medicinal products (ATMP) has emerged with promising approaches for the treatment of advanced/refractory cancer diseases. Recent clinical trials have demonstrated that cellular-based immunotherapies have an impact on patient’s overall survival and quality of life. Simultaneously, patients are well informed about these cutting-edge technologies and demand the efficient and safe use of resources.
The aim of this course is to educate and train health care professionals in the innovative field of ATMP manufacturing and clinical application.
Participants will attend educational sessions about ATMP and cellular therapy products with minimal manipulation, understanding the activities performed by physicians, nurses, technicians and pharmacists inside a cellular therapy department and will be able to distinguish between adverse reactions, incidents and errors, and to correct and prevent them.
Participants will be challenged to develop new protocols that may support basic research or produce clinical grade cellular products for patient administration. At the end, participants will have the opportunity to present and discuss their work with a group of experts.
Health professionals with training in medicine, pharmacy or nursing
LEARNING OBJECTIVES >> KNOWLEDGE AND SKILLS TO DEVELOP
- To recognize the organizational structure of the collection centre, the manufacturing facility and their articulation with the clinical program;
- To know the ATMP circuit from cell collection to manufacturing process, cryopreservation, quality control and clinical application;
- To acquire expertise about export and import cellular therapy products including transport rules.
- To experience the use of personal protective equipment and hygiene rules for proper laboratory work within classified and controlled environment;
- To obtain technical and scientific information about cryobiology and know the potential risks of liquid nitrogen to the operator;
- To perform processing, freezing, cryopreservation and thawing techniques with cellular therapy products;
- To perform cell counts by flow cytometry, cell viability studies and clonogenic assays;
- To participate in verification steps and observe validation procedures and qualification reports;
- To analyse the quality of the final product and validate it for clinical use.
Curriculum vitae with evidence of the following criteria:
- Academic education: graduation degree certificate (mandatory) in medicine, pharmacy or nursing;
- integrated master degree in medicine or pharmacy
- Training and presentation of scientific studies
- Work experience: years of activity in the field
- Recommendation letter