The ATMPs have arrived in today’s reality.

🧬 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.

💡In our virtual lecture, our ATMP experts will present you an overview on what to consider:

“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 – Current news & views
• Part 5: ATMPs – Introduction to facility concepts for cellular drug products
• Part 6: ATMPs – Quality Control, specifications and method validation
• Part 7: From R&D to GMP manufacturing license – a generic project plan
• Part 8: Discussion / Q&A / Test

Participants who will pass a final test will receive a training certificate.

The block lectures are organized in cooperation with the Fresenius University of Applied Sciences in Idstein & Wiesbaden as parts of their master's programs. External participants are welcome!

The content of the lectures on both dates is identical.

📍 Location: Fresenius University of Applied Sciences, Idstein/Germany (online via Teams)

📆 Date: November 11, 2026 | 1:00-6:00 PM, UTC+1 (incl. breaks)

🌐 Language: English

Dr. Hans-Georg Eckert, external lecturer at the Fresenius University Idstein, Senior GMP Consultant and CEO of Valicare, as well as Dr. Robert E. Zoubek, Executive Consultant at Granzer Regulatory Consulting Services GmbH, Dipl. Ing. Peter Rehm, Facility Planning at Syntegon Technology, Dr. Stefan Löffler, Senior GMP Consultant at Valicare and Dr. Tom Teichmann, ATMP-GMP Consultant at Valicare will introduce you to the exciting and promising world of ATMPs.

📍 Location: Fresenius University of Applied Sciences, Wiesbaden/Germany (online via Teams)

📆 Date: December 4, 2026 | 9:55 AM-12:10 PM / 1:05-3:20 PM, UTC+1 (incl. breaks)

🌐 Language: English

Dr. Hans-Georg Eckert, external lecturer at the Fresenius University Idstein, Senior GMP Consultant and CEO of Valicare, as well as Dr. Stefan Löffler, Senior GMP Consultant at Valicare and Dr. Tom Teichmann, ATMP-GMP Consultant at Valicare will introduce you to the exciting and promising world of ATMPs.

Are you interested? Choose your preferred date and register now using one of the links below!

💠November 11, 2026 | 1:00-6:00 PM, UTC+1 | English (part of the master's courses "Medicinal and Pharmaceutical Guidelines and Regulatory Affairs" and "Regulatory Affairs and Ethics in Biomedicine)

💠December 4, 2026 | 9:55 AM-12:10 PM / 1:05-3:20 PM, UTC+1 | English (part of the master's course "Biopharmaceuticals and Biothechnology")