Do you know the regulatory requirements for medicinal products of advanced therapy, also known as ATMPs?
Dr Hans-Georg Eckert, Senior GMP Consultant at Valicare GmbH and lecturer at the Fresenius University of Applied Sciences in Idstein, will give the above-mentioned block lecture on 28 May 2021.
The virtual block event will take place as part of the module 'Legal Regulations and Ethics in Applied Biomedicine' via Zoom, from 10:00-12:00 and 13:00-15:30. It is divided into 4 sections, each concluding with a question and discussion session.
Part 1: Fundamentals, special features, 'game changer' qualities, products
Part 2: Regulatory fundamentals in Europe
Part 3: ATMP-GMP-Anforderungen
Part 4: Quality control, specifications, and method validation
Questions & Discussion
The event for students of Hochschule Fresenius will also be open to external participants.
If you know little about ATMPs so far but would like to learn about their special features and the specific regulatory requirements for their production, you are warmly invited to attend the event.
Just send us an email at (info@valicare.com) and register. You will then receive the access details for the Zoom meeting. But don't wait too long, as the number of external participants is limited to 30, and registrations will be processed on a first-come, first-served basis. We would be happy to issue a certificate of attendance after the event.
Dr. Hans-Georg Eckert is the Managing Director of Valicare GmbH based in Frankfurt, where he also serves as a Senior Project Manager and Senior GMP Consultant. He has been working in the GMP environment for over 20 years and has carried out more than 600 projects related to GMP topics in general, and ATMPs in particular. Read more about his background here.
Feel free to contact us independently of the event if you have questions about ATMPs or if you would like information about our specialized GMP services.