Dr Sabine Hauck
dequra pharma consult hauck, Chair of ECA ATMP Interest Group
Referent:innen
Hintergrund
Advanced Therapy Medicinal Products (ATMPs) are an important component of innovative and personalized medicine. They offer ground-breaking treatment options for serious and often incurable diseases. These therapies include for example CAR-T cells, viral vectors (such as AAV, lentiviruses and adenoviruses), plasmid DNA and tissue engineering. To ensure that these products are of consistent quality, safe and effective, they must be manufactured in accordance with GMP (Good Manufacturing Practice) rules. These rules ensure that the manufacture and control of products is safe, standardized and traceable. To comply with these standards, it is important to understand the basics in the first place - and this is often a challenge.
In this training course, you will learn the basic GMP rules for ATMPs. We start with the fundamentals and cover the following topics:
In this training course, you will learn the basic GMP rules for ATMPs. We start with the fundamentals and cover the following topics:
- Basic terms: What does GMP mean, how does it look like to ATMPs, and what are ATMPs actually?
- Overview of the regulations: From EU regulations and EMA guidelines to GMP guidelines and important pharmacopoeia chapters for ATMPs.
- Special features of ATMPs: How do they differ from traditional medicinal products?
This course offers you the opportunity to develop a solid basic understanding of GMP and ATMPs - the first step on the way to the safe manufacture of these innovative therapies.
Zielgruppe
This webinar addresses itself to all, which are involved in Quality Assurance, Research and Development, Regulatory, Quality Control and Manufacturing of ATMP. This course creates a basic understanding of GMP and ATMP.
Technical Details:
To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.
Timing and Duration:
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Please be aware: The recording does not include the Q & A sessions.
Training Course Documentation and Certificate:
The presentation will be made available as PDF-files via download during the online training course. After the successful completion of the online training, you are able to download the certificate of attendance.
Please be aware: The recording does not include the Q & A sessions.
Training Course Documentation and Certificate:
The presentation will be made available as PDF-files via download during the online training course. After the successful completion of the online training, you are able to download the certificate of attendance.
Programm
The training will give a brief and concise overview of ATMP and GMP so that participants will hear the following presentations:
GMP – A first Approach
GMP – A first Approach
- Definition, context and history
- What makes GMP so special?
- GMP for ATMPs in the EU and outside Europe
ATMP - To be or not to be
- Which products are ATMPs?
- Overview of regulations
- Special features of ATMPs
Recording from 03 July 2025
Duration of Recording: 1h 28min
| ECA-Member*: | € 349,- |
| Regular Fee*: | € 399,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
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