Dr Sabine Hauck
dequra pharma consult hauck, Chair of ECA ATMP Interest Group
Referent:innen
All times mentioned are CEST
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.
Date / Technical Requirements / Presentations / Certificate
Date of the Webinar
Thursday, 03 July 2025, 14.00 – 16.00 h CEST
We use Webex for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our trainings and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.
The presentations will be made available to you prior to the Live Online Training as PDF files.
After the event, you will automatically receive your certificate of participation.
Thursday, 03 July 2025, 14.00 – 16.00 h CEST
We use Webex for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our trainings and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.
The presentations will be made available to you prior to the Live Online Training as PDF files.
After the event, you will automatically receive your certificate of participation.
Programm
Gesamtes Programm als PDF herunterladen
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
| ECA-Member*: | € 349,- |
| Non ECA Member*: | € 399,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
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E-Mail: info@concept-heidelberg.de
Teilnehmerstimmen
Seminarprogramm als PDF
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