INSIGHTS ON CLINICAL TRIAL REGULATORY ISSUES

• Disclosure Management System: Build Or Buy?

  Clinical trial disclosure regulations are tightening worldwide. In order to maintain compliance, sponsors must determine whether to build an internal disclosure management system or buy a solution.

• Key Updates To Implementing Regulation (EU) 520/2012

  The evolving pharmaceutical landscape demands continuous regulatory adaptation to safeguard patient safety and ensure compliance, including making updates to reinforce a more centralized, transparent, and technologically aligned EU pharmacovigilance system.

• How Sponsors Can Drive Success With Central eSource At Investigator Sites

  Centralized eSource systems enable complex clinical trials to align with key regulatory frameworks, including ICH E6(R3), ICH E8(R1), and 21 CFR 312, to meet the highest standards of GCP.

• Validating Generative AI: A Framework For Reliability And Compliance

  With structured CSA-driven validation and expert guidance, organizations can harness generative AI’s advantages safely and effectively, ensuring accuracy, compliance, and operational excellence.

• FDA Shifts Reshape Drug Development

  6/13/2025

  Listen to regulatory leaders share CRO insights on how FDA changes are reshaping global clinical trials, sponsor strategies, and investment trends in a new podcast series debut.

• We Need Regulatory Clarity—Not Complexity In Clinical Trial Technology

  6/12/2025

  The current U.S. deregulatory momentum should not diminish compliance standards but instead serve as a call to streamline and modernize regulatory guidance.

• HTA In Japan: The Glass Remains Half Full (For Now)

  6/12/2025

  While Japan's current HTA system is seen as pro-innovation, potential reforms in 2026 could expand its scope, creating uncertainty for manufacturers in one of the world's largest markets.

• Early Access Program In France: How Much Of An Opportunity Is It?

  6/12/2025

  Navigating France’s Early Access Program is more complex than ever. Amid declining approval rates and mandatory data collection, here’s what pharmaceutical companies need to know about the changing landscape.

• Inclusion Of Health-Related Quality Of Life (HRQoL) And Other Patient-Reported Outcomes (PROs) In FDA Labels

  6/12/2025

  With a growing emphasis on patient-centric drug development, new research examines how frequently patient-reported outcomes are actually making it onto United States Food and Drug Administration labels.

REGULATORY MULTIMEDIA

• FDA Shifts Reshape Drug Development

  Listen to regulatory leaders share CRO insights on how FDA changes are reshaping global clinical trials, sponsor strategies, and investment trends in a new podcast series debut.

• Navigating Special Regulatory Pathways For Advanced Therapy Development Success

  Don't let regulatory hurdles slow you down. Learn from leading experts about special designations like RMAT and PRIME to accelerate your advanced therapy development and ensure success.

• Mastering GMO & Companion CDx Trials: The EU Regulatory Playbook

  This presentation offers strategic and operational guidance for navigating the regulatory challenges of conducting gene-modified organism (GMO) trials in Europe.

• Mastering The Complexities Of Gene Therapy Document Writing

  Gain the insight and strategic flexibility needed to confidently navigate the unique scientific, regulatory, and documentation challenges of gene therapy development.

• Balancing Science With Intellectual Property

  Joshua Kresh, Emily Michiko Morris, and Mark Schultz from IPPI: The Intellectual Property (IP) Policy Institute discuss the dos and don’ts of IP and trade secrecy protections for biotech.

• Achieving Regulatory Compliance With A Unified Immunogenicity Strategy

  This presentation equips viewers with the knowledge and tools needed to navigate the intricacies of designing immunogenicity assays that comply with both European IVDR and US FDA regulations.

• Assessing Diversity In Early-Phase Clinical Trials In A Rapidly Changing Regulatory Environment

  Learn more about structuring early-phase trials to address population variation and the contributing factors to safe drug administration, both of which are essential to a drug development plan.

• Illuminating IHC: Right-Sizing Your Validation And Regulatory Strategy

  In this presentation, expert speakers provide an in-depth exploration of the essential validation and regulatory strategies for Immunohistochemistry (IHC).

• Blueprint For Efficient Clinical Trial Disclosure

  Explore a comprehensive framework that helps organizations continuously assess and improve their clinical trial disclosure processes.

• Accelerating Clinical Data Review With Traceable Workflows

  Discover how streamlined workflows and enhanced collaboration between data managers and medical reviewers can boost clinical trial efficiency, improve data quality, and ensure patient safety.