Biologics – From R&D to GMP

Content and aim of the webinar

It is a long journey from the first idea to an innovative new medication. 95 percent of potential pharmaceutical products fail even before entering the first clinical trial, often due to a lack of professional support for research e.g. with regard to GMP production or regulatory requirements.

In order to close this gap and to support the translation from the project idea to the first clinical trials, this webinar aims to bridge between early research and development and the first GMP-related productions.

For this purpose, five sessions are presented, which are structured as follows:

• Regulatory Framework in Germany and Quality by Design
• Cell line development and Tech Transfer
• GMP Cell Banking
• Manufacturing Process
• Risk-based approach

Schedule

The webinar will be weekly on Thursday at 2 pm CET with the first session on Thursday, 19.11.2020.

Registration

Please send an e-mail if you are interested in participating in the webinar. Please also indicate your TTU affiliation and your research topic in this expression of interest. You are welcome to list topics and questions, which should be reflected in the webinar.
Final registration will be required in mid of August after the agenda has been sent out.

E-mail to the organizer