Dr Sabine Hauck
dequra pharma consult hauck, Chair of ECA ATMP Interest Group
Referierende
Shortcuts: compact learning units of 1–3 hours – perfect for a quick overview or a focused deep dive into a specific topic. Book online, receive access within minutes and benefit from 7 days of on-demand availability, giving you maximum flexibility in your day-to-day work.
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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.
Zielsetzung
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.
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.
Programm
The shortcut 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
Weitere Informationen
The purchase process for the GMP & GDP Shortcuts is handled via the sales platform Digistore24 (www.digistore24.com). Please understand that it is not possible to place an order on account in this case.
By clicking the “Book now” button at the top right, you will be redirected to Digistore24. After successful payment, you will automatically receive a confirmation email from Digistore24 and an email from Memberspot (our streaming provider) asking you to register.
Afterwards, you will have access to the purchased video for 7 days.
Please note: The booking is valid only for the registered participants. The use by other persons is prohibited and constitutes an infringement of copyright.
Presentation and certificate:
Starting from the purchase date, the presentation will be available for you to download in Memberspot for 7 days. Afterwards, the participants can download a certificate of attendance.
Contacts
Questions regarding content:
Mr Clemens Mundo, +49 6221 84 44-45, mundo@concept-heidelberg.de
Questions regarding Organisation:
Mr Maximilian Bauer, +49 6221 84 44-25, bauer@concept-heidelberg.de
Duration of the shortcut: 1h 28min
Recorded in July 2025
Please note:
When you click on “Register”, you will be redirected to www.digistore24.com. Once your payment has been successfully completed, you will immediately receive 7 days’ access to the Shortcut you ordered via the Memberspot streaming platform. We kindly ask for your understanding that payment by invoice is not possible.
When you click on “Register”, you will be redirected to www.digistore24.com. Once your payment has been successfully completed, you will immediately receive 7 days’ access to the Shortcut you ordered via the Memberspot streaming platform. We kindly ask for your understanding that payment by invoice is not possible.
Teilnahmegebühr
| Regular Fee*: | € 399,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Aufzeichnung/weitere Termine nicht verfügbar
Aufzeichnung/weitere Termine nicht verfügbar
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