Janevik-Ivanovska, Emilija (2018) Regulation of Radiopharmaceuticals - what is required for a good clinical application. In: 3rd International Scientific Conference of the Faculty of Medical Sciences - University of Tetova & 2nd Annual Albanian Congress of Trauma & Emergency Surgery, 8-10 November 2018, Ohrid.
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Abstract
The development and introduction of new radiopharmaceuticals in the last years is very rapid and highly innovative both for diagnostic and therapeutic applications. The translation into the clinic, however, is hampered by the high regulatory demands. Radiopharmaceuticals are highly regulated, because they are controlled both as regular medicinal products and as radioactive substances. This can pose a hurdle for their development and clinical use. Radiopharmaceuticals are fundamentally different from other medicinal products and these regulations are not always adequate for their production. Strict compliance may have a huge resource impact, without further improving product quality. The focus of this paper is to overview the most important players that provide safe and targeted application of radiopharmaceuticals - the European Pharmacopoeia and his important role in defining quality standards, relevant and current EU requirements, controversial Good Manufacturing Practice (GMP) and Good Radiopharmaceutical Practice (GRPP), International Atomic Energy Agency (IAEA) recommendations and Basic Safety Standard and European Association of Nuclear Medicine (EANM) Guidelines as supplementary documents in relation to GMP, documentation and toxicity studies supporting professionals in the application process. We argue that future legislation be further harmonized and state risk assessment as the gold standard for implementation of drug quality regulations for the preparation of unlicensed radiopharmaceuticals, both for diagnostic and therapeutic purpose.
| Item Type: | Conference or Workshop Item (Lecture) |
|---|---|
| Subjects: | Medical and Health Sciences > Clinical medicine Medical and Health Sciences > Other medical sciences |
| Divisions: | Faculty of Medical Science |
| Depositing User: | Emilija Janevik |
| Date Deposited: | 06 Feb 2019 08:12 |
| Last Modified: | 06 Feb 2019 08:12 |
| URI: | https://eprints.ugd.edu.mk/id/eprint/21517 |
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