Level 3: High End Courses of EANM
15-16 de noviembre de 2018, Viena, Austria
The course focuses from the basics and fundamentals of Good Manufacturing Practice (GMP) through User Requirement Specification (URS), Validation, Deviations and Facility Planning. Moreover Radiation Safety, the question how to build up and manage a quality risk management system will be covered in the course.
Additionally it explains the increasing regulatory demands from laboratory work to clinical trials, going from laboratory notes to an Investigational Medicines Product Dossier (IMPD).
- Fundamentals of GMP
- Consequences of GMP Related Actions
- The Needs and Demands to get a Radiopharmaceutical into a Clinical Trial
- Points of Consideration when Planning a Radiopharmaceutical Facility
- Quality Risk Management
The target audience includes Radiochemists and Radiopharmacists with the interest to increase the understanding of GMP and the consequences of different GMP related activities (e.g. persons who have attended the EANM Radiopharmacy Courses) but as well Pharmacists who wants to gain a better understanding for GMP in the context of Radiopharmaceuticals. To sum up, persons working in the field of nuclear medicine who wants to gain a better understanding in GMP and what is needed for “First in Human” use, i.e. clinical trials.
Introduction to Radiopharmacy (Basic NM Webinar Series, part on “GMP and radiopharmaceuticals”: Minute 00:43:39-00:54:24)