APICES has been acknowledged in The Journal of Obstetrics and Gynaecology for its medical writing contribution to a retrospective study on fertility preservation counselling and practice among women with Hodgkin and non-Hodgkin lymphoma.
APICES acknowledged in lymphoma fertility study
We want to share the acknowledgment that APICES has received in a fertility retrospective study in the recent paper published in The Journal of Obstetrics and Gynaecology, in which APICES has collaborated in medical writing activities.
This means a great motivation to all the APICES team to give continuity to the implication we have in every project in which we collaborate. APICES is very proud of the recognition of our work, and we would like to thank Dra. Mariola Hernández Martínez, and Ferring for giving us the opportunity to appear in the acknowledgments of the publication and congratulate them and all the investigators for their project success.
This retrospective study aims to evaluate obstetric outcomes and the onset of menopause in patients with Hodgkin and non-Hodgkin lymphoma, by analyzing electronic medical records of individuals who attended the Haematology Department at the study site between 2000 and 2018, with follow-up data collected until December 2023.
Key Takeaways: First-in-human trials in the EU are governed by Regulation (EU) No 536/2014 and the EMA’s first-in-human guideline (EMEA/CHMP/SWP/28367/07 Rev 1). Sponsors must submit a complete Clinical Trial Application via the CTIS portal and obtain both Part I...
Key Takeaways: Phase I dose escalation design in the EU is governed by ICH E8(R1), EMA first-in-human guidance (EMA/CHMP/SWP/28367/07 Rev.1), and EU Clinical Trial Regulation 536/2014 via CTIS. The classical 3+3 design is increasingly replaced by model-based...
EU MDR clinical investigation requirements have fundamentally changed how Medtech sponsors plan and execute device studies in Europe. Regulation (EU) 2017/745 replaced the clinical investigation provisions of Directive 93/42/EEC (MDD) and introduced a more stringent, harmonised framework across all 27 EU member states. For sponsors running investigations in Spain, Germany, France, the Netherlands, or any other member state, understanding which pathway applies to their study is the single most consequential regulatory decision before CIP submission.