The Role of Regulatory Affairs in Advancing Alzheimer’s Research with Elizabeth Shaffer
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.
Episode Recap:
- In this episode, we’re talking with ATRI’s Regulatory Affairs Manager, Elizabeth Shaffer (0:40)
- How did you get involved with regulatory affairs? (2:27)
- What is regulatory, and how has it evolved since you started working in this field? (5:46)
- What role does the IRB play in clinical research? (8:37)
- How do you make sure you’re communicating clearly to trial participants? (9:35)
- What are you most excited about in your work today? (13:10)
- How does your work make research faster and more accessible? (17:09)
- What does the consent process look like for participants throughout a trial? (18:36)
- What keeps you motivated to do this work, and what are you most proud of? (24:49)
- What is your hope for the future of ATRI? (30:09)
