Thursday, September 25, 2025

Hello, The FDA is rewriting the rules of clinical trials. Are you ready?

Greetings!


The story begins with a familiar scene. A protocol is finalized, enrollment opens, and within weeks cracks appear. Recruitment slows, eligibility proves too narrow, and the data no longer reflects what regulators expect. What once passed as “good enough” now holds development back.


The FDA has recognized this problem and issued new guidance. It is not a suggestion but a blueprint for change, pushing sponsors and CROs toward smarter, more inclusive, and evidence-driven trial models.


To help navigate this shift, we are hosting a free live webinar: The Modern Clinical Trial: FDA’s Blueprint for Change. The session will be led by Dr. Tigran Uzunyan, a clinical research scientist with over eighteen years of experience in academia, industry, and regulatory-driven trial design.


You will learn why outdated eligibility models are slowing enrollment, how PK/PD and clinical recovery can replace rigid calendar rules, and how risk-based approaches to concomitant medications create access without compromising safety. The discussion will also show how these strategies connect to decentralized trials and real-world evidence.


The session concludes with a live Q&A. Attendance is free. Reserve your spot today and prepare to align with the FDA’s evolving expectations.

Date & Time

Oct 9, 2025

2:00 PM - 3:00 PM (EST)


How is the Workshop delivered?

Live. Virtual. Interactive. Instructor-led.

Interested in this workshop?

Register today by calling our team at 416-628-7575 or email us at events@aapspharma.com

LinkedIn  Web

No comments:

Post a Comment