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. Jacek Koziorowski

RadCad

Dr. Nicholas Gillings

Copenhagen University Hospital, Rigshospitalet

Objectives

During this Live Online Training, 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

Quality Control
Quality Assurance
Inspection and Audits
Qualification and validation
Radiopharmaceutical manufacturing.

Technical Details:

To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.

Timing and Duration:
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.

In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.

Please be aware: The recording does not include the Q & A sessions.

Training Course Documentation and Certificate:
The presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.