{"type":"rich","version":"1.0","provider_name":"Transistor","provider_url":"https://transistor.fm","author_name":"The Alzheimer's Research Podcast","title":"The Role of Regulatory Affairs in Advancing Alzheimer’s Research with Elizabeth Shaffer","html":"<iframe width=\"100%\" height=\"180\" frameborder=\"no\" scrolling=\"no\" seamless src=\"https://share.transistor.fm/e/a0b011fb\"></iframe>","width":"100%","height":180,"duration":2085,"description":"Regulatory affairs is one of the key mechanisms that keeps clinical trials moving forward — ensuring participant consent, overseeing the review process, and helping trials occur faster. In this episode, Elizabeth Shaffer joins the podcast to discuss her work as Regulatory Affairs Manager for the Alzheimer’s Therapeutic Research Institute (ATRI) and the Alzheimer’s Clinical Trials Consortium (ACTC). She shares an overview of the consent process for participants, explains what Institutional Review Boards (IRB) are, and how they oversee research.  She discusses some key advancements in the regulatory process for Alzheimer’s clinical trials throughout her career. Elizabeth also reflects on ATRI’s progress and shares some of her hopes for the future of Alzheimer’s research. \n\nEpisode Recap:\nIn this episode, we’re talking with ATRI’s Regulatory Affairs Manager, Elizabeth Shaffer (0:40)\nHow did you get involved with regulatory affairs? (2:27)\nWhat is regulatory, and how has it evolved since you started working in this field? (5:46)\nWhat role does the IRB play in clinical research? (8:37)\nHow do you make sure you’re communicating clearly to trial participants? (9:35)\nWhat are you most excited about in your work today? (13:10)\nHow does your work make research faster and more accessible? (17:09)\nWhat does the consent process look like for participants throughout a trial? (18:36)\nWhat keeps you motivated to do this work, and what are you most proud of? (24:49) \nWhat is your hope for the future of ATRI? (30:09)\n\nLearn more about ATRI\nConnect with Elizabeth Shaffer","thumbnail_url":"https://img.transistorcdn.com/x6BQT4am9b3UONiz06CLD2gyZ4nDsjxooaMyKpH7uw0/rs:fill:0:0:1/w:400/h:400/q:60/mb:500000/aHR0cHM6Ly9pbWct/dXBsb2FkLXByb2R1/Y3Rpb24udHJhbnNp/c3Rvci5mbS81ZGEw/YWFkYjg3MzdhMGY5/NTJjN2VkMGNhZDlj/NGRlNi5wbmc.webp","thumbnail_width":300,"thumbnail_height":300}