With upcoming changes in regulatory expectations, Notified Bodies are placing stronger emphasis on scientific rigor, evidence defensibility, and traceability in Clinical Evaluation Reports (CERs) — not just check-the-box compliance. For medical device manufacturers, this means traditional CERs may no longer suffice.

This webinar helps you adapt your CER strategy to meet the 2026 standards. You’ll discover how to build audit-ready CERs, craft systematic literature reviews (SLRs) with clarity and traceability, and integrate documentation workflows that stand up to deeper scrutiny.

The ICH M4Q guideline is undergoing its first major revision in more than two decades, reshaping how pharmaceutical companies will organize, justify, and maintain quality information across the product lifecycle. As global expectations rise and regulatory scrutiny intensifies, understanding M4Q(R2) is essential for teams responsible for CMC documentation and submission strategy.

In this on-demand webinar, our expert breaks down the proposed updates in M4Q(R2) and explains how new elements such as Core Quality Information (CQI), Development Summary & Justification (DSJ), and Product Lifecycle Management (PLCM) will influence current and future submissions. Learn what is changing, why it matters, and how this modernization supports more structured, consistent, and efficient regulatory filings.

 

Why Watch

If your teams support CMC authoring, quality documentation, or lifecycle management, this session will help you understand how the revised M4Q framework may impact your processes, timelines, and submission readiness. The webinar outlines where the industry is heading and offers clarity on how organizations can prepare for a shift toward more structured and lifecycle-driven CMC information.

Watch the webinar recording now and gain insight into adapting your CMC documentation strategy for a modernized regulatory environment.

Watch Now: AI in Action – Tech-Empowerment in Medical and Technical Writing

Artificial Intelligence (AI) is already reshaping the way regulatory submissions are created, reviewed, and delivered across life sciences. This webinar, hosted in partnership with RAPS, explores how AI is actively transforming medical and technical writing for pharmaceutical and medical device companies.

From live tool demonstrations to real-world case studies, you’ll gain first-hand knowledge on how leading organizations are implementing AI to increase efficiency, reduce manual workloads, and elevate submission quality.

Don’t miss this opportunity to understand what practical AI adoption looks like today—and how your team can start leveraging it for measurable compliance and operational gains.

 

Watch Now: The Regulatory Landscape in 2025 – What You Need to Know

Pharmaceutical companies today are navigating an increasingly dynamic and complex regulatory environment. As we move through 2025, staying informed about regulatory changes and preparing for what lies ahead is essential for maintaining compliance and accelerating market access.

In this exclusive on-demand webinar, our experts explore key regulatory trends, submission challenges, and global authority expectations that will define the pharmaceutical regulatory landscape. Don’t miss this opportunity to gain strategic insights and practical knowledge from seasoned regulatory affairs experts.

Stay Ahead of 2025 Regulatory Shifts!