GMP and Quality Requirements for Radiopharmaceuticals - Live Online Training
29/30 April 2025
Course No. 21864
Speakers
Arjan Langen
GE Healthcare
Dr Franz Schönfeld
Regierung von Oberfranken
All times mentioned are CEST.
Objectives
During this course, representatives of regulatory authorities will present the current development of radiopharmaceutical regulations and their experiences during the inspection of manufacturing establishments including the possible impacts of the new Annex 1. Furthermore, speakers from contract laboratory and manufacturing will share their experiences with GMP implementation. You will become acquainted with possible solutions for the special challenges and practical approaches on room qualification for GMP-compliant manufacturing. They will cover the really “hot topics” in the world of pharmaceutical QA and QC like Qualification, Validation, Monitoring and Good Distribution Practice and more with a special focus on Radiopharmaceuticals.
The speaker team is set up to provide you with the unique possibility to discuss the current status and the future expectations with representatives of national authorities as well as professionals from universities, hospitals and engineering.
Background
The manufacturing of radiopharmaceutical products confronts the producing establishment with a collection of challenges. On the one hand, there is the challenge by the contradictory requirements of quality and safety guidelines of pharmaceutical products and the standards of staff safety and radiation protection. On the other hand, there are issues of small batch sizes and short shelf life. The short shelf life necessitates fast transportation and application to the patient. These circumstances mean that classical requirements like sterility testing before release and application cannot be fulfilled and GDP is a real challenge.
Target Group
This course is aimed at the personnel of hospitals, pharmaceutical companies, their suppliers and authorities who are involved in
Date / Technical Requirements / Presentations / Certificate
Date of the Live Online Training Tuesday, 29 April 2025, 08.30 h - 17.30 h Wednesday, 30 April 2025, 08.30 h - 17.30 h All times mentioned are CEST
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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.
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Testimonials
Seminar Programme as PDF