INSIGHTS ON CLINICAL TRIAL REGULATORY ISSUES

• A New Era In Good Clinical Practice Guidelines

  Learn how the updated ICH GCP E6(R3) guidelines are reshaping trial conduct with simplified principles, stronger data governance, and a focus on risk-based, patient-centric research.

• Keep Up With The Latest Disclosure Regulations

  Failing to comply with disclosure rules can leave sponsors open to fines and penalties. Here, we present the latest disclosure requirements, enforcement mechanisms, and tips on how best to stay compliant.

• The Answer To Your Pharmacovigilance Challenges: AI-Powered Adverse Event Detection

  A proven, AI-powered safety platform can accelerate adverse event detection and safety data extraction to ease the burden on safety professionals and better protect patients.

• Expectations For Plain Language Summaries Continue To Evolve

  Plain language summaries (PLS) are growing in importance as a requirement in global transparency. Focusing on protocol and results summaries, we cover expectations and best practices for global PLS implementation.

• How Emerging Technologies Are Challenging Traditional IRB Oversight

  11/6/2025

  Uncover how sponsors, CROs, and study monitors can navigate FDA expectations and Institutional Review Board (IRB) requirements when integrating AI and Software-as-a-Medical-Device into clinical trials.

• How AI-Enhanced CAPA Systems Actually Work

  11/6/2025

  Learn how AI can accelerate root cause analysis, predict quality risks, and streamline CAPA without compromising compliance or overwhelming your team with practical strategies.

• Maintaining Compliance In Gene Therapy Trials For Neurological Conditions

  10/29/2025

  To identify efficacious treatments for neurological conditions, drug sponsors must design ethical clinical trials that protect participants and caregivers while ensuring compliance with regulators.

• Ensure IRB And IBC Success For Your Gene Therapy With Strategic Planning

  10/23/2025

  To successfully bring innovative gene therapies to patients with neurological disorders, drug sponsors must design safe and compliant clinical trials with rigorous approaches to ethics and consent.

• Empowering Mid-Size Pharma Companies With Integrated Drug Development, Regulatory Strategy, And AI Innovation

  10/23/2025

  A consultative, tech-enabled CRO can help mid-size pharma achieve targets by supplementing skillsets, expanding global reach, and designing an effective clinical, regulatory, and operational strategy.

REGULATORY MULTIMEDIA

• A New Era In Good Clinical Practice Guidelines

  Learn how the updated ICH GCP E6(R3) guidelines are reshaping trial conduct with simplified principles, stronger data governance, and a focus on risk-based, patient-centric research.

• Keep Up With The Latest Disclosure Regulations

  Failing to comply with disclosure rules can leave sponsors open to fines and penalties. Here, we present the latest disclosure requirements, enforcement mechanisms, and tips on how best to stay compliant.

• Expectations For Plain Language Summaries Continue To Evolve

  Plain language summaries (PLS) are growing in importance as a requirement in global transparency. Focusing on protocol and results summaries, we cover expectations and best practices for global PLS implementation.

• Beyond Traditional TRSM: Transforming Clinical Operations At Scale

  Explore how organizations can transform from managing dozens of siloed, protocol-specific RTSM implementations to achieving unified, portfolio-level clinical operations.

• Almac Clinical Leader Solutions Expo September 2025 - IRT

  Complexity is no longer the exception in high stakes clinical trials, it has become the rule.

• IQVIA Technologies Clinical Leader Solutions Expo September 2025 - IRT

  Have you seen an increase in the number of IRT inspections over the past 3 years?

• Patient Centered Research: Challenges And The Role Of HEOR

  This video features expert insights into the evolving landscape of Patient-Centered Research and the role of HEOR in risk-benefit assessments.

• Navigating Disclosure Complexity: The Power Of Human-Centered AI

  Identify key regulatory hurdles that sponsors face when integrating Artificial Intelligence (AI), as well as the impact of AI on clinical trial disclosure and transparency.

• Ensuring Compliance In Gene Therapy Trials: IRB And IBC Views

  Explore ethical and regulatory challenges in neurological gene therapy trials, with expert insights on IRB/IBC collaboration, consent protocols, and oversight for vulnerable populations.

• The New Era Of Project Optimus: Implications For Oncology Development Strategy

  In this presentation, expert speakers bring the impact of Project Optimus to life through real-world case studies and practical examples.