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e-Learning in 5 modules: concept, data requirements and the AMNOG process up to the price negotiation
This online seminar provides a comprehensive overview of global regulatory affairs, covering strategies for setting regulatory policies, developing global regulatory dossiers, understanding HTA interfaces, enhancing global communication, and staying updated on ICH guidelines, ISO IDMP updates, and global regulatory trends.
This course offers a deep dive into patient involvement in HTA processes across Europe, with a focus on the UK and Germany - learn practical approaches, regulatory insights, and how to engage meaningfully with patient organisations.
The online training with details on development, quality, CMC, approval and market access (including an update on the upcoming EU HTA) for advanced therapy medicinal products. Qualifiy now!
This online conference offers compact expert talks and diverse perspectives on global regulatory strategies, digital transformation and evidence generation. Expect focused insights, practical takeaways and lively discussions with experienced speakers - and stay informed about the latest developments in global regulatory practices.