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Monthly FDA Guidance and Regulatory News Review - August 2026
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Where Regulatory Strategy Meets What’s Next
RAPS Convergence US: September 15-17, 2026 – Charlotte, NC
Veristat is pleased to attend RAPS Convergence 2026, where regulatory professionals, health authority representatives, and industry leaders come together to discuss the evolving requirements shaping healthcare product development. With more than 100 sessions spanning pharmaceuticals, biologics, medical devices, and other emerging areas, this year’s meeting puts regulatory innovation and collaboration at the center of the conversation.
We’re looking forward to connecting with regulatory leaders in Charlotte to discuss the challenges sponsors are navigating across increasingly complex global development programs. Veristat brings regulatory strategy together with clinical development, biometrics, and medical writing expertise to anticipate requirements, strengthen development strategies, and build a clearer path toward successful submissions and approvals.
Veristat on the Agenda
From Access to Insight: A Call for Transparency and Disclosure | Honz Slipka, Associate Principal Transparency Specialist
Wednesday, September 16, from 3:20pm to 3:50pm
In today’s world, public access to clinical trial data is non-negotiable for accountability, equity, and scientific advancement. High-profile calls for transparency from politicians and public figures urging pharmaceutical companies to release clinical data from studies such as those related to COVID-19 vaccines have highlighted gaps in public communication and regulatory clarity. Platforms such as ClinicalTrials.gov make study protocols and status updates publicly searchable; regulatory bodies, including the European Medicines Agency (EMA) and Health Canada, publish clinical trial data for approved products; and sponsor websites frequently provide detailed trial outcomes.
Solutions Circle: Navigating Lay Language 2026 and Beyond | Evan Richardson, Senior Director, Regulatory Services
Thursday, September 17, from 2:05pm to 2:35pm
This presentation explores the evolving regulatory requirements for lay language writing and how health authority expectations are being integrated into regulatory deliverables. It will address practical challenges in developing lay language summaries within demanding clinical and operational timelines, including template development, planning, and implementation. Through real-world examples, attendees will learn how to apply key lay language requirements, including those established by EMA, to create clear, user-friendly materials that meet regulatory expectations.
Meet with Us
Connect with us at the event to explore how Veristat’s scientific leadership and focused capabilities can help advance your clinical and regulatory milestones.
Angie Gray, Senior Manager, Regulatory Operations
Demetrius Carter, Senior VP, Services Operations & Regulatory Services
Evan Richardson, Senior Director, Regulatory Services
Honz Slipka, Associate Principal Transparency Specialist
Schedule a Meeting in Advance
Complete the form on this page to reserve time with our team. We welcome the opportunity to learn about your upcoming programs and explore how Veristat can support your development strategy.
Our Expertise
Whether you're launching a first-in-human study or navigating complex regulatory pathways, Veristat delivers integrated expertise and personalized support across the development lifecycle:
- Clinical Operations Excellence
- Global Regulatory Strategy & Submissions
- Full-Service Clinical Development Solutions
If you’ll be at the meeting, let’s make time to discuss how we can help move your programs forward.
Schedule A Meeting
Meet with us at the 2026 RAPS Convergence US Conference by filling out the form below.
8 min read
Monthly FDA Guidance and Regulatory News Review - July 2026
Aug 14, 2026 Veristat Blog
This July 2026 regulatory update focuses on the FDA finalizing six guidances that addresses antiviral next-generation...