Key Session Takeaways:

• Align clinical, quality, and regulatory teams around a centralized inspection readiness strategy

• Build end-to-end visibility through system integration, ensuring consistency across TMF, CTMS, and quality platforms

• Use process mapping and ownership models to reduce ambiguity and ensure accountability across teams

• Implement inspection readiness frameworks that support new studies from startup through closeout

• Focus on process-driven preparation over fire-drill responses—by embedding compliance into daily workflows

• Leverage Priya’s experience leading mock inspections, BIMO preparation, and Veeva Vault rollouts to enhance cross-functional alignment

• Address challenges of data integrity, vendor oversight, and documentation traceability through unified processes

• Foster a culture where every team member is inspection-aware, not just inspection-ready

Priya Chaturvedi,
Global Vice President,
Clinical Quality Assurance, Eisai

Embedding Compliance into Clinical Operations Decision-Making as a Foundation for Inspection Readiness

• Explore how Clinical Operations leaders embed inspection readiness into decision-making across the study lifecycle
• Discuss strategies for balancing timelines, resources, and quality while maintaining GCP compliance
• Examine cross-functional collaboration with Quality, TMF, and Medical teams to support continuous inspection readiness
• Understand how inspection readiness is integrated from trial start-up through study closeout
• Learn how to build documentation practices that support clear, inspection-ready study narratives
• Review key operational levers and oversight mechanisms used to maintain inspection readiness at every phase
• Gain insights into fostering a culture of compliance and proactive risk management within clinical teams

Kathleen Frenia Cohen,
PharmD, Senior Vice President,
Clinical Development Operations, avalo Therapeutics

Andr’e Campos,
Senior Vice President,
Global Clinical Operations, ILiAD Biotechnology

Brian Dean,
Vice President,
Clinical Operations, Gameto

Adapting to a Modernized GCP Framework

• Overview of ICH E6(R3): What’s changed and why it matters for inspections

• Risk-based thinking in practice: Embedding quality and compliance into trial design and execution

• Documentation expectations: What inspectors may now ask under the R3 lens

• Shifting from reactive to proactive oversight: Real-time readiness across clinical operations, TMF, and vendors

• Training and cross-functional alignment: Building inspection readiness into roles and responsibilities
• Case examples: How early adopters are operationalizing E6(R3) and what inspection trends they’re seeing

• What regulators are signaling: Insights from recent inspection activity aligned with R3 principles

Stefan Van den Akker,
Executive Director,
Research Development Quality & Risk Management, ACADIA Pharmaceuticals

Dawn Lundin,
Vice President, Global Quality
Lykos Therapeutics

• Learn how to build a scalable inspection readiness program by understanding the systems and developing SOP to support the technology in place.
• Integrate TMF, quality, and regulatory systems through process mapping and technology implementation
• Coordinate cross-functional readiness across clinical, medical, and pharmacovigilance teams
• Prepare for FDA inspections using BIMO checklists, mock inspections, and real-time documentation practices

Cristina Monastero, M.S.,
Director of Clinical Document Management and Inspection Readiness,
Larimar Therapeutics

Maureen Cunningham, Senior Director, United Therapeutics

• Rebuilding inspection readiness process through QRBM, SOPs, and mock inspections to set the foundation of inspection readiness

• Developing study startup systems aligned with ICH E6(R3) to close gaps before they appear

• Lessons learned from EMA and Health Canada inspections during active trials
• Managing clinical monitoring CAPAs and CRO-related inspection risks

• Establishing clinical quality oversight outside of traditional QA to lead proactive readiness

Maureen Cunningham,
Senior Director,
United Therapeutics

• Establishing a State of “Inspection Steady”: Creating simple, scalable processes and systems that maintain constant readiness rather than scrambling before inspections.

• Optimizing Oversight Through CTMS and Analytics: Using clinical trial management systems and real-time data analytics to identify study hotspots, site-level risks, and trends that require proactive intervention.

• Collaborating With Vendors and System Owners: Building oversight tools and workflows in partnership with external providers to strengthen communication and cross-functional process alignment.

• Training, Access, and Lifecycle Controls: Ensuring training timelines, user access, and deactivation processes are tracked and documented within inspection-ready systems.

• System Validation and Communication Flow: Managing system validation activities while enabling consistent communication and collaboration across functional groups.

• Managing the Inspection Front and Back Rooms: Lessons from recent MHRA, Health Canada, and FDA inspections—including how to prepare teams, structure inspection support, and handle slow or incomplete data flow.

• Audit Trails, Quality Events, and Sponsor Accountability: Tracking audit trails, logging quality events, and ensuring sponsor-level oversight even when responsibilities are outsourced to CROs or vendors.

Robert Staszewski,
Associate Director, Clinical Oversight & Systems,
United Therapeutics

• Focused on site partnership over policing, emphasizing collaboration rather than audits

• Used metrics-driven quality management to proactively identify and resolve documentation gaps

• Developed a behind-the-scenes TMF process with a single-owner, integrated data structure

• Leveraged case models and quality briefs to provide structured insights into documentation flow

• Rebuilt site relationships by understanding data origins and respecting operational realities

• Shifted the approach from “auditing the site” to auditing the relationship and workflows

• Offered inspection coaching to help site staff understand regulator expectations and reduce anxiety

• Promoted long-term growth and operational maturity through trust and transparency
  
  Niloy Shah, MS,
  Executive Director, Research & Development Quality.
  Replumune

Empowering Teams, Systems, and Standards to Ensure High Quality and Impactful Sponsor/ Site Relationship

• How clinical sites can proactively prepare for FDA, sponsor, and internal audits

• Strategies for training site staff on GCP, documentation practices, and inspection protocols

• Leveraging technology (eISF, eLogs, CTMS, TMF) to streamline access to essential documents

• Coordinating with sponsors and CROs to align on inspection readiness expectations
• Identifying and addressing high-risk areas such as informed consent, protocol deviations, and source data

• Building a culture of quality through regular mock inspections, self-audits, and continuous learning

Monika Joshi, MD,
MRCP, Professor of Medicine,
Penn State Cancer Institute

Kevana Nixon, DCFT, LMFT, AAMFT-AS
On-campus clinical Supervisor
Drexel University

• A 360-degree inspection readiness strategy was implemented to align teams, documents, and systems across both sponsor and site inspections, ensuring all aspects of preparation were accounted for before regulators arrived.

• The presenter played a central role in leading mock inspections and interviews, helping study teams prepare for real-world scenarios through role-playing exercises and targeted feedback.

• During a live site inspection in South Korea, she supported the team in the backroom, managing document requests, tracking communication, and ensuring timely responses to inspector needs.

• Transitioning from mock to actual inspection involved applying lessons learned—such as clarifying document ownership, refining interview answers, and rehearsing response logistics—to reduce confusion and streamline inspection day operations.

• Effective document preparation and request management proved critical, with anticipated materials organized in advance and real-time request tracking ensuring a smooth and compliant inspection process.

Soyoung Chong,
Principal; Quality Lead, Quality Assurance Programs, Genentech,
A Member of the Roche Group

• How to design and conduct meaningful TMF mock inspections

• Who should participate, and what should be in scope?

• Creating checklists aligned with FDA/EMA expectations and ICH E6(R3)

• Lessons learned from mock inspection findings and how they translate to real audits

• Role-playing regulatory inspectors: internal vs. external simulation strategies

Jamie Toth

• Identifying which TMF metrics actually drive compliance and inspection readiness

• From lagging to leading indicators: setting up your TMF dashboard

• Using KPIs to trigger QC reviews and risk mitigation actions

• Communicating TMF health to senior leadership and quality teams

• Avoiding common pitfalls: metrics that mislead instead of inform

• Integrating TMF quality into protocol development and operational planning

• Establishing clear ownership and accountability across functions and partners

• Key metrics and leading indicators to monitor TMF health in real time

• Aligning your TMF with ICH E6(R3) and regulatory expectations

• Using TMF QC/QA outputs to drive inspection readiness

• Building audit trails and metadata strategies that withstand inspection scrutiny

• How globalization, technology, and regulatory harmonization are reshaping inspection expectations

• Insights from recent FDA, EMA, MHRA, and PMDA inspections

• Preparing for hybrid and remote inspections as a long-term standard

• Evolving risk-based inspection models: what sponsors and sites need to know

• Cross-border data sharing and privacy considerations during inspections

• How regulators are assessing digital systems, AI, and decentralized trial models

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