dequra pharma consult hauck, Chair of ECA ATMP Interest Group
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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.
Objectives
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:
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.
Programme
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
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
Further Information
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.
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