Future-Proof Your EU Radiopharma Operations
If you are involved in radiopharmaceutical production in the EU, you have likely heard the news. The EMA and PIC/S have launched a joint revision of Annex 3, and a brand-new guideline on the quality of radiopharmaceuticals was drafted in December 2025. The regulatory landscape you have been operating under for the past decade is changing significantly.
These revisions bring stricter expectations for quality documentation, a clearer definition of active substance controls, and more stringent oversight of investigational products. The GxP Trainings Radiopharmaceutical Manufacturing program is your strategic advantage in navigating this evolving environment, ensuring you are not just compliant with the current Annex 3, but fully prepared for the upcoming changes.
Practical Training for New EMA Guidelines
We don’t just teach you what the regulations are today; we explain where they are heading. The course covers the hot topics of the new EMA quality guideline, including the four main product categories – ready-to-use products, kits, generators, and precursors – and how CMC expectations are shifting.
You will learn to adapt your documentation (Module 3 of the CTD) to meet new stability study requirements. The program provides frameworks for setting release specifications that are scientifically justifiable and practical under the new PIC/S alignment.
Training for Every EU Radiopharma Role
The course addresses the specific pain points of European manufacturing:
For Academic Research Centres – Get phase-appropriate GMP strategies to meet Regulation 536/2014 requirements without overcomplicating research workflows.
For Commercial Producers – Harmonize your quality systems to meet both EMA and global PIC/S standards, crucial if you operate in multiple regions.
For Quality Assurance Teams – Master revised expectations for environmental monitoring, personnel training, and sanitation emphasized in the new Annex 3.
Get Certified for the Annex 3 Overhaul
The GxP Trainings program includes 14 in-depth lessons, lifetime access, and a verifiable certificate recognized across the industry. When the new Annex 3 is officially published, you can come back to refresh your knowledge and ensure your systems are aligned.
Stay ahead of the regulatory curve in Europe. Secure your spot in the program now.
Radiopharmaceutical Manufacturing Training Course | GxP Trainings
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