🧬 Cell and Gene products (CGTs) can cure diseases for which there has been no hope of recovery so far. From autologous therapies like CAR-T cells to allogeneic cell therapies, the market is growing at a rapid pace. Giving lot of patients a new chance.

But bringing Advanced Therapeutic Medicinal Products (ATMPs) to market is a rocky road. Process knowledge, manufacturing capacity and regulatory expertise are essential for success.

🍵 Take a coffee and find out how to proceed and what you need to consider in the virtual lecture:

“Introduction to the requirements on pharmaceutical manufacturing and testing of ATMPs”

You will receive a general overview of ATMPs and the mandatory national and European regulations. Furthermore, the focus will be the way from R&D to manufacturing authorization and the requirements for quality control, the manufacturing process, and the production facility.

Agenda:

• Part 1: ATMPs – Classification, therapeutic indications, examples
• Part 2: ATMPs – Regulatory basics in Germany and Europe
• Part 3: ATMP-GMP – Specific product and process related requirements
• Part 4: ATMPs – Quality Control, specifications and method validation
• Part 5: ATMPs – Introduction to facility concepts for cellular drug products
• Part 6: From R&D to GMP manufacturing license – a generic project plan
• Part 7: Discussion / Q&A
• Part 8: Test

The block lectures are organized in cooperation with the Fresenius University of Applied Sciences in Idstein as parts of their master's programs in WS 2025.

Dr. Hans-Georg Eckert, external lecturer at the Fresenius University Idstein, Senior GMP Consultant and CEO of Valicare and additional ATMP experts will introduce you to the exciting and promising world of ATMPs.

Valicare, Telstar, Syntegon – strategic life cycle management partner for seamless processes & sustainable solutions.

📍 Location: Fresenius University, Idstein/Germany (online)

📆 Date: October 30 & November 27, 2025, 01:00 - 06:00 pm

🌐 Language: English

The content of the lectures on both dates is identical.

Are you interested? Find all key information at a glance in the document below, including the online access details. Choose your preferred date!