Annex 2 & Co. - GMP Compliance for Biopharmaceuticals
27/28 May 2025, Vienna, Austria
Course No. 21817
Speakers
Dr. Marcel Günther
Regierungspräsidium Tübingen
Dr. Matthias Leitritz
Rentschler Biopharma
Dr. Marcus Fido
Mfi Bio-Consulting
Stephan Löw
CSL Behring
Friederike Wedelich
Regierungspräsidium Tübingen
Objectives
This Education Course concentrates on regulatory and practical requirements regarding biopharmaceutical production. From clinical phases to routine manufacturing, practical examples and case studies will facilitate the implementation of GMP in your daily Business.
The course will treat the topics of routine inspection from regulatory bodies and customers, quality assurance and quality control as well as in laboratory and production.
Speakers from manufacturing, laboratory, consultancy and authority will show their expectations as well as their experiences in GMP implementation.
Background
In defiance of all throwbacks in the last years, a progression of new approvals of biopharmaceuticals is expected. Furthermore after the end of the protection of patents, biotechnical generics will be added.
Especially in the field of biotechnology you find often challenges to fulfil the regulatory requirements on production and quality assurance.
Industry and authorities have to face the new and expected changes in the regulatory Guidelines.
Target Group
This course is advisable to people who
are involved in regulatory inspections,
work in quality units at biotech companies,
implement GMP in biotech production,
are responsible for GMP requirements pre-approval phases.
Date / Venue / Presentations / Certificate
Tuesday, 27 May 2025, 09.00 h – 17.30 h (Registration and coffee 08.30 h – 09.00 h) Wednesday, 28 May 2025, 08.30 h – 17.30 h
Doubletree by Hilton Vienna Schönbrunn Schlossallee 8 1140 Vienna, Austria Phone +43/1/89110 Email info@doubletree-schonbrunn.at
The presentations for this event will be available for you to download and print before and after the event. Please note that no printed materials will be handed out on site and that there will not be any opportunity to print the presentations on site.
After the event, you will automatically receive your certificate of participation.
Testimonials
Seminar Programme as PDF