Pharmaceutical Biotechnology for Non-Biotechnologists - Live Online Training
17/18 September 2025
Course No. 22066
Speakers
Dr Sabine Hauck
dequra pharma consult hauck, Chair of ECA ATMP Interest Group
Dr Marcus Fido
Mfi Bio-Consulting
Stephan Löw
CSL Behring
Dr Robert Gallitzendörfer
Local Government of Upper Bavaria, GMP Inspector
All times mentioned are CEST.
Background
From a historical view, biopharmaceuticals & biosimilars are no new business. Antibiotics and vaccines have been well known for more than 60 years. But with the marketing authorisation of the first biopharmaceutical product, produced by gene technology in the 80s, a new era of biopharmaceutical and biotechnological development and manufacturing started.
Future pharmaceutical products based on biotechnology and Biosimilars as well as Biologics will become more and more important and present a higher share of pharmaceutical products.
This course will provide non-Biotechnologists with an overview and insight in pharmaceutical biotechnology. It will also present the opportunities of biotechnology in GMP manufacturing and quality control.
Common aspects of product analytics will be discussed just as well as regulatory aspects of Biopharmaceuticals (bacteria, yeast and cell culture) and specific requirements on clinical studies and marketing authorisation. It will furthermore focus on topics like virus clearance reduction, cell banking, media fills and on dedicated rooms and personnel. The course will be completed by a presentation of the current comprehensive bodies of Legislation.
Target Group
This course is addressed to all people interested in pharmaceutical biotechnology related to GMP manufacturing, analytics, product release and marketing authorisation.
Date / Technical Requirements / Presentations / Certificate
Date of the Live Online Training Wednesday, 17 September 2025, 09.00 h – 17.30 h Thursday, 18 September 2025, 08.30 h – 16.00 h All times mentioned are CEST
We use WebEx for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our trainings and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
Testimonials
Seminar Programme as PDF