The Web-Workshop organized by AIFA is targeted at GMP Inspectors, with the aim of providing an overview of the principles incorporated in the EU regulations concerning the radiopharmaceuticals lifecycle, from Quality assessment of CTD-Module 3 to EU GMP compliance inspections of commercial manufacturing facilities, covering topics and issues related to the whole regulatory process.

The Workshop also addresses resources, procedures and state-of-the-art technologies aimed at ensuring product quality and GMP compliance for radiopharmaceutical manufacturers.

The speakers’ panel includes regulators, experienced professionals from academia, nuclear medicine hospital departments, manufacturers and equipment/technology suppliers.

The Web-Workshop is organized in two days:

• day one is focused on regulatory aspects, end users’ and academic perspectives;
• day two is focused on manufacturers’ and technology suppliers’ perspectives.
• Industrially prepared radiopharmaceuticals are significantly different from “traditional” medicinal products in both their characteristics and their production process.

The peculiar features of radiopharmaceuticals involve a series of challenges for the manufacturer:

• sterile and radioactive injectables (contradictory requirements of quality and safety of pharmaceutical products and radiation protection for staff);
• small batches and short shelf life (fast delivery to hospitals and administration to patients);
• administration to patients prior to completion of some QC testing, such as sterility and radionuclidic purity.

The EU GMP requirements applicable to radiopharmaceuticals are in part determined by the nature of these products. The manufacturer Quality Assurance system is fundamental to minimize the possible risks to quality that may not be identified through QC pre-release testing and to prove that the critical aspects of the manufacturing operations are adequately controlled.

Registration

Registration to this event is intended for 2 participants from any Medicines Regulatory Authority belonging to EU/EES MS and EU Candidate Countries. Participation is free of charge, and attendants will receive a certificate of participation at the end of the workshop.

All registrations should be made by March 23.

For any further information, please contact training.gxp@aifa.gov.it

Published on: 18 February 2022