Self-Paced Online Course

Learn at your own pace through interactive and structured online modules.

Flexible Access

On-demand access allowing learners to progress according to their own schedule.

European Advanced Cell Therapy Manufacturing & Regulatory

In partnership with the Andalusian Network for the Design & Translation of Advanced Therapies (ANd&tAT), ISCT is proud to offer this online Educational Program on Advanced Therapy Manufacturing free-of-charge for ISCT members. The program aims to foster the training of professionals in the fundamentals of ATMP regulations and the specific knowledge necessary for the development of medicinal products for cell therapy, gene therapy, and tissue engineering.

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Based on Past Participant Survey Results

98%

Said the course content was relevant

95%

Felt the course was well organized with adequate time per segment

94%

Found the training valuable to their work

Foundational principles of cell and gene therapy manufacturing, including media, equipment, and facility design
Quality control measures such as cell identity, sterility, and viral safety testing
Quality assurance frameworks to ensure clinical-grade product consistency and compliance
Product development pathways from laboratory research to clinical application
GMP compliance requirements specific to ATMP manufacturing
Structure and preparation of Investigational Medicinal Product Dossiers (IMPD) for clinical trials
Biosafety considerations in donor selection, cell manipulation, and regulatory oversight
Regulatory requirements for gene therapy products, including GMO and pharmacovigilance aspects
Strategic considerations for intellectual property, commercialization, and future ATMP innovations

Cell and Gene Therapy Manufacturing Methods
Quality Assurance Principles
Product Development Pathways
Good Manufacturing Practice (GMP) Compliance
Investigational Medicinal Product Dossier (IMPD) Writing
Biosafety Considerations

Designed For

Professionals seeking to learn more about EU regulations, cell therapy, gene therapy, tissue engineering, and best practices for ATMPs.

Access Instructions

First time users will be required to create an account on the ANd&tAT e-learning platform.

Program URL:
http://ws140.sspa.juntadeandalucia.es/masteratmps/course/index.php?categoryid=7

Enrolment Key: ISCT2025

A CMaT or ISCT membership is required for this course. Not an ISCT Member? Register now →

For full details on our course policies, including cancellations, complaints and appeals processes and our privacy policy, click here.

ELIGIBILITY REQUIREMENTS

None

ACCESS INSTRUCTIONS

First time users will be required to create an account on the ANd&tAT e-learning platform.

Member exclusive access, login required.

Program URL: http://ws140.sspa.juntadeandalucia.es/masteratmps/course/index.php?categoryid=7
Enrolment Key: ISCT2025

Not an ISCT Member? Register now → View Course Policies Contact Us

A CMaT or ISCT membership is required for this course.

The Resource Hub provides supporting materials to help reinforce learning before, during, and after the course.

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UPON COMPLETION, YOU WILL RECEIVE:

Certificate of Course Completion from ISCT

Note: Completion of all training modules and passing the quizzes is required to earn the certificate.

What Past Participants Are Saying

“Overall, I found the course to be very well designed and easy to follow. I especially appreciated the video-based format and having access to the slides, which made it easier to review key concepts afterward and apply them to my own work.”

Daniel K.

“Great course, very well organized and highly informative. The content was comprehensive and clearly structured, which helped me understand how the different components connect in real clinical and manufacturing settings.”

Sarah L.

“The material aligned closely with the learning objectives, and I really valued the interactive elements. The Q&A explanations and practical examples made the sessions engaging and helped reinforce the concepts in a meaningful way.”

Kevin P.

Principles & Applications of Cell Therapy Biomanufacturing, Characterization, Regulatory

Hybrid 9-Week Program Self-paced + Live Virtual

Learn More →

An online course blending self-paced modules with live discussions featuring CGT experts. Designed to deliver essential best practices in cell therapy biomanufacturing, characterization, and regulatory frameworks.

Format: 12 hours self-paced 4 hours live-virtual

European Advanced Cell Therapy Manufacturing & Regulatory

European Advanced Cell Therapy Manufacturing & Regulatory

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Principles & Applications of Cell Therapy Biomanufacturing, Characterization, Regulatory

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