Radiopharmaceuticals: A practical CMC and quality perspective - Navigating current and future EMA requirements/EU regulatory standards

- The new EMA quality guideline: Structure and core requirements - CDMO (Contract Development and Manufacturing Organisation) contribution to CMC strategy and regulatory dossier integration - The sponsors perspective: Owning CMC strategy across the lifecycleRadiopharmaceuticals are facing a pivotal regulatory moment. This seminar brings together experts from a regulatory authority, a CDMO, and a sponsoring company to provide practical, up-to-date guidance on CMC and quality requirements under current and forthcoming EU standards.LernzieleRadiopharmaceuticals are subject to a rapidly evolving regulatory landscape. At its centre stands the ongoing revision of the EMAs core quality guideline. Beyond this revision, further legislative updates are on the horizon (e.g. revision of ICH M4Q, emerging EU additional quality master file system).- This seminar provides a practical, application-oriented overview of the current and forthcoming EU regulatory framework for radiopharmaceuticals, covering CMC and quality requirements. Bringing together regulatory authority, CDMO, and sponsor perspectives in one program, participants gain both a solid understanding of regulatory requirements and direct insight into how they translate into daily practice, also at the interfaces.With major regulatory revisions still in progress, early awareness is key, giving your company the opportunity to assess implications and start preparing in good time.- Please note that the content addressed on the EMA Guideline on Quality of Radiopharmaceuticals refers to the draft version of the guideline currently in place.ZielgruppenThis seminar is designed for regulatory affairs specialists and CMC managers working with radiopharmaceuticals in pharmaceutical companies, hospital pharmacies, CDMOs, or regulatory authorities who need to navigate the current and upcoming EMA requirements with confidence.