About
The ATMP field encompasses products of different types including gene therapies, cell therapies, and tissue-engineered products, that, despite their differences, fall within the definition of an advanced therapy medicinal product. These cutting-edge treatments have the potential to revolutionize the way we approach complex diseases, offering innovative solutions that address the root causes of conditions at a genetic or cellular level.
Throughout this course, we will cover the fundamental science behind ATMPs, their development and manufacturing processes, regulatory frameworks, and the ethical considerations that come with their use.
This workshop will provide a comprehensive and practical guide to understanding key different features among ATMP classes and how to classify them correctly. In addition, the differing regulatory requirements of different health authorities will be briefly discussed. From a manufacturing point of view, the course delves into several practical changes that need to be considered when developing and marketing an ATMP to anticipate and avoid potential problems.
By the end of this program, you will have a solid understanding of how ATMPs are transforming medicine and how they are shaping the future of healthcare.
Programme
- Introduction and advanced therapeutic medicinal products (ATMP) classification
- ATMP vs traditional medicines
- ATMP market
- Classification
- Dissecting the different ATMP classes with examples of marketed ATMPs
- Differences between US and EMA regulations in ATMPs
- Manufacture of Gene Therapy Product
- General concepts
- Dissecting the manufacturing process of T-cell technology, passing through the description of some process-related criticalities, including the use of closed systems and equipment exploiting that technology
- ATMP challenges from development to pre-marketing authorization
- Starting and raw materials: identification and evaluation to establish a robust supply chain in a production-oriented view
- Process development: risk assessment and Quality by Design (QbD) as tools to identify, evaluate and monitor your process and product (QTPP, CPP, CQAs and CMAs)
- Practical tips to make as smooth as possible the transition from pre-GMP to fully-GMP production
- Manufacturing: technical features to consider to avoid the dreaded bottlenecks while scaling up the process
- Hints on non-clinical and clinical development
Lecturers
Lieve De Wolf
Lieve De Wolf is an industrial pharmacist who graduated in 2015. Her career spans several roles in the pharmaceutical industry, including Validation Engineer & QA Project Engineer at Alcon-Novartis, Downstream Process Expert at eTheRNA, External Quality Manager for CAR-T & Advanced Therapies at Johnson & Johnson and quality expert for Perrigo and Cellcarta.
In 2020, she joined the QbD ATMP core team, where she became the Core Team Leader in January 2023. In her free time, she likes to walk with her golden retriever Bruno and connect with family and friends.
Useful Information
The course will take place online on Zoom platform.
It will be activated in live online mode once a minimum number of interested people has been reached.
Registration Fee
Early Bird: € 915,00*
Ordinary: € 1.095,00*
Freelance – Individual – Academy – Public Administration: € 640,00*
* for Italian companies: +22% VAT
The fee includes: tuitions, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.
Who Should Attend
Addressed to people actively involved in the development and quality of ATMPs, such as:
- Manufacturing Science and Technology (MSAT)
- QA and Regulatory Affairs
Participant experience
Minimum GMP industry experience.
Teaching Methods
Interactive training based on a slide deck, with direct involvement of the audience.
Questions and quizzes before and after discussing a specific topic.
The course will be delivered as soon as the minimum number of interested people has been reached. Provide your details to be contacted as soon as the course becomes available.
At the end of the training, you will be able to
