Colorado Chapter: Keeping Up with the FDA’s Changing Ways (ACRP 2025 Conference Replay)
This event will be presenting a ACRP webinar replay session
Location:
Virtual via Zoom
Event Description:
The landscape of clinical trial design, conduct, and regulation continues to shift thanks to the rapid infusion of technology and an increased emphasis on inclusion and access. As a result, the U.S. Food and Drug Administration (FDA) and Congress are reevaluating their stances in a number of areas in order to further speed the path to healthcare innovation. However, these changes in policy can present operational challenges for sites and sponsors in the day-to-day management of trials and patient care. This session will run through the latest guidance changes and what they mean for sites and sponsors in 2025. Areas of focus will be the updated guidance on informed consent, diversity action plans, digital health technologies, decentralized clinical trials and Form FDA 1572 reform, use of real-world evidence, and changes to the FDA's Bioresearch Monitoring Program inspection processes. Additionally, the speakers will address the final ruling on taxing patient stipends, the Inflation Reduction Act, and the Food and Drug Omnibus Reform Act of 2022's mandate for innovation.
Speakers:
Sophia McLeod
Senior Director, Government Relations | The Association of Clinical Research Organizations (ACRO)
Catherine Gregor
Chief Clinical Trial Officer | Florence Healthcare
Learning Objectives:
- Identify major FDA and U.S. policy updates for 2025 that affect clinical trial design, conduct, and oversight.
- Describe how recent regulatory changes impact day-to-day trial operations at research sites and sponsor organizations.
- Recognize practical compliance considerations related to decentralized trials, digital health technologies, diversity requirements, and FDA inspections.
Registration & ACRP Contact Hour Information:
- Chapter Member (registration with or without contact hours): $0
- ACRP Member (registration only): $0
- ACRP Member (registration + contact hours): $15
- Non-Member (registration only): $0
- Non-Member (registration + contact hours): $75
After registering, please visit the event's community page to find the login information or any additional event updates, and to communicate with the event organizer.
To claim contact hours: Register and purchase the contact hours and attend the event. After attending the event, visit learning.acrpnet.org and log into your ACRP account. Click the “GO TO MY COURSES” box. Find the event in your dashboard, confirm your attendance, and take the event evaluation between 1 and 30 days following the event to obtain the online certificate. After 30 days, contact hours are no longer available.