Being prepared for a good clinical practice (GCP) inspection requires ensuring compliance with regulations, maintaining data integrity and prioritizing patient safety. With the introduction of the ICH E6 R3 draft guidelines, a new risk-proportionate approach emphasizes the importance of processes aligned with trial design and execution.
Understanding GCP Inspections: Regulatory authorities expect organizations to be inspection-ready at all times, whether the inspection is announced, unannounced or part of the marketing authorization approval process. Inspections aim to verify compliance with GCP and other regulations, ensuring trial participant safety and data reliability.
Key Changes with ICH E6 R3: The new guidelines introduce principles around data governance, emphasizing the management of data integrity, traceability and security. They highlight the need for risk assessment processes to be embedded in trial protocols, requiring a proportionate approach based on the level of risk associated with each trial.
To ensure compliance, organizations should focus on developing robust risk management programs, implementing consistent risk-based approaches throughout the trial lifecycle and conducting audits and mock inspections to identify potential risks and prepare teams.
Inspection Challenges and Solutions: Common inspection findings often include issues related to data governance, documentation discrepancies and inadequate oversight. Addressing these requires effective collaboration between sponsors, service providers/vendors, and investigator sites, as well as a continuous commitment to refining processes.
Preparation for GCP inspections is an ongoing journey. While inspections can be perceived as daunting, they drive organizations to strengthen compliance and improve trial conduct. Embracing the principles outlined in the ICH E6 R3 draft can lead to better risk management, enhanced data integrity and more reliable trial outcomes.
Register for this webinar today to learn essential strategies for inspection readiness, with insights on the updated ICH E6 R3 guidelines, risk-proportionate approaches and how to build a robust compliance program.
Speaker
Ernesto Vera-Sanchez, MD, PhD, MPH, Vice President, Department Head GxP Strategy, Allucent
Dr. Ernesto Vera-Sanchez has nearly 20 years of experience as a regulator and an EMA & AEMPS GXP Inspector. His comprehensive knowledge of clinical trial regulations and guidance from EMA/FDA/MHRA/PMDA, as well as his extensive experience in inspection strategy and related procedures, lend to his wide-ranging expertise. Dr. Ernesto has led over 400 regulatory inspections at clinical investigator sites, CROs, sponsors and vendors.
Message PresenterWho Should Attend?
This webinar will appeal to VPs, Directors, Managers and Heads involved in:
- Clinical operations/Clinical research
- Quality assurance/compliance
- Regulatory affairs/strategy
- Clinical project management/trial oversight
- Research and development (R&D)
- Data integrity, clinical data management and biostatistics
- Clinical pharmacology/pharmacometrics
- Medical writing/medical affairs
- Preclinical/nonclinical research
- Chief Medical Officers (CMOs) and CEOs of small and medium-sized biotech/pharmaceutical companies
What You Will Learn
Attendees will learn about:
- Key strategies for ensuring inspection readiness, including proactive preparation, risk management and compliance best practices
- Insights on the upcoming ICH E6 R3 guidelines, focusing on risk-proportionate approaches, data governance and new regulatory expectations
- How to build and implement a robust inspection readiness program that aligns with the latest regulatory updates
- Practical advice on conducting audits, mock inspections and improving oversight of service providers and clinical trial sites
- The benefits of maintaining a continuous compliance culture to mitigate risks and enhance trial success
Xtalks Partner
Allucent
Allucent is on a mission to help bring new therapies to light by solving the distinct challenges of small and mid-sized biotech companies. The company is purpose-built through the convergence of leading providers to address this unmet need. Today, Allucent is a global provider of comprehensive drug development solutions, including consulting, clinical operations, biometrics, and clinical pharmacology across a variety of therapeutic areas. With more than 30 years of experience in over 60 countries, Allucent’s individualized partnership approach provides experience-driven insights and expertise to assist its clients in successfully navigating the complexities of delivering novel treatments to patients.
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