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Radiopharmaceuticals: Challenges in Regulation and Manufacturing

One of the topics at the 3rd International Forum of Pharmaceutical Inspectorates (IFPI) will be a discussion of issues related to the regulation and manufacturing of radiopharmaceuticals (RPP).

Radiopharmaceuticals represent one of the most specialized areas of the pharmaceutical industry. The unique nature of working with radioactive materials, requirements for manufacturing facilities and equipment, and the need to ensure product quality and safety present complex challenges for both manufacturers and regulatory authorities.

During the session, experts will examine the regulatory aspects of the production and distribution of RPPs, challenges encountered during inspections, and approaches to developing and implementing an effective quality management system.

Special attention will be given to GMP requirements for facilities, equipment, and personnel working with radioactive materials. Experts will highlight specific industry characteristics that must be considered when organizing production and conducting pharmaceutical inspections, and will list typical non-conformities identified during inspections of RPP manufacturing facilities.

Thus, the session will provide a practical perspective on radiopharmaceuticals—covering aspects of regulation, inspection, production organization, and quality assurance.

The III International Forum of Pharmaceutical Inspectorates will take place on 16–17 November 2026 in Hanoi, Vietnam.


Ask a question to the IFPI Speaker:

IFPI organizers are giving Forum participants the opportunity to ask questions to the speakers.*

Please submit your questions — the moderator will deliver the most interesting ones to the speakers during the session. This is a great opportunity to get direct feedback from experts and influence the direction of the discussion.

You can submit your question via email to info@ifpi-forum.com or via WhatsApp.

*Only participants who have registered for the Forum may ask questions to the speakers