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The assessment of endometrial safety is one of the key requirements for the clinical development of new products for hormone therapy (HT) to treat menopausal symptoms in women who have a uterus. Both the Food and Drug Administration (FDA) in the United States and the European Medicines Agency (EMA) provide detailed guidance on the requirements for the evaluation of biopsies to prove endometrial safety. However, there are some discrepancies between the European and the US requirements, making it difficult to fulfil both guidelines simultaneously. In order to facilitate multinational clinical trials performed within clinical programs to develop novel HT products, we developed an approach considering both guidance documents as far as possible and proposed solutions for issues that are inconsistently described in these guidelines. A table with the required sample sizes is given. Our recommendation for a unified approach for the estimation of the hyperplasia rate for hormone therapies fulfils the intent of the recommendations of both the FDA and the EMA and thus leads to a globally harmonized drug development for hormone therapies.

Introduction: The introduction of hybrid imaging modalities such as combined positron emission tomography and computed tomography (PET-CT) has altered image analysis and reporting as well as the expectations of the referring physicians. The training in multimodality imaging is unsatisfactory at the moment because no specialisation is adequate for full analysis of the resulting image data. In the recent "White paper of the European Association of Nuclear Medicine (EANM) and the European Society of Radiology (ESR) on multimodality imaging", ways to adjust training opportunities and, thus, to improve the situation were proposed. We think that action is urgently required in order to provide optimal training in multimodality imaging., Opinion: Training in both nuclear medicine and diagnostic radiology should be restructured to allow for optional integrated training in multimodality imaging while maintaining the depth and detail of the individual specialties., Suggested Action: We propose criteria for the training in multimodality imaging that can be implemented locally and fast without precluding a yet to be defined regulatory framework.