GMP and Quality Requirements for Radiopharmaceuticals
18/19 June 2024, Heidelberg, Germany
Course No. 21272
Speakers
Dr. Franz Schönfeld
Regierung von Oberfranken
Arjan Langen
GE Healthcare
Prof. Dr. Gerald Reischl
Universität Tübingen
Prof. Dr. Clemens Decristiforo
University Hospital Innsbruck
Dr. Nicholas Gillings
Copenhagen University Hospital, Rigshospitalet
Dr. Dirk Freitag-Stechl
CUP Laboratorien
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 nuclear medicine departments from universities and hospitals as well as from industry 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
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