Let's Start With a Quick Snapshot

• Roughly how many individual case safety reports (ICSRs) does your team process per year? Options: < 1,000, 1,000–5,000, 5,001–25,000, 25,001–100,000, > 100,000
• Which product types generate the majority of your reports? Options: Prescription pharmaceuticals, Biologics / biosimilars, Over-the-counter products, Medical devices, Combination products, Clinical trial investigational products, Other
• How many distinct regulatory jurisdictions currently require expedited reporting for your products? Options: 1–5, 6–15, 16–35, 36–70, > 70
• Who currently owns expedited reporting and regulatory gateway relationships in your organization? Options: Head of PV / Safety, Regulatory Affairs, Quality / Compliance, VP/Director of Safety, Shared across functions, Third-party vendor
• In one sentence, what gives you confidence your safety operations are working today?

The Stakes: What Keeps You Up at Night?

• If a single missed expedited report could trigger a regulatory inspection tomorrow, where would you instinctively look first?
• How many instances of missed deadlines or late submissions have you recorded in the last 24 months? Options: 0, 1–2, 3–5, 6–10, > 10, Unsure
• Tell me about a recent near-miss or late submission: what broke, who noticed it, and what was the immediate consequence?
• What would the most serious consequence of a missed expedited report look like for your company? Options: Regulatory warning/letter, Fines or penalties, Product recall or suspension, Inspection with remediation, Reputational harm, Other
• How does your leadership react when compliance risk rises—do they mobilize resources, escalate to QA/regulatory, or treat it as operational noise? Options: Immediate executive escalation, QA/regulatory drives response, Operational team handles it, Mixed/varies by case, No consistent pattern
• When timelines compress unexpectedly, what emotions or pressures do you observe in your team?

Where Your Current Process Quietly Fails

• Which part of your intake-to-submission workflow do you suspect is most likely to silently cause a late report today?
• Which channels feed case intake into your system? Options: Call center, Email, Online safety portal, EHR/EMR integration, Clinical trial CRFs, Literature monitoring, Third-party vendor feeds, Other
• What is your average elapsed time from initial intake to case creation in the safety database? Options: < 1 hour, 1–24 hours, 1–3 days, 3–7 days, > 7 days, Varies widely
• Which manual tasks consume the most reviewer time and introduce the highest risk (e.g., MedDRA coding, narrative writing, causality assessment, QC)?
• How many separate systems or handoffs does a typical case go through before submission? Options: 1 system, 2 systems, 3–4 systems, 5–7 systems, More than 7
• Do you currently rely on any informal workarounds or one-off scripts to meet reporting obligations? If yes, describe what worries you about them.

Who Holds the Keys (and Who Actually Moves the Levers)?

• If an inspector asked for the person accountable for ensuring no expedited reports are missed, who would you point to—and why might that answer be uncomfortable?
• Which functions must be actively involved to keep reporting compliant? Options: PV/Drug Safety, Quality Assurance, Regulatory Affairs, IT/Integration, Clinical Operations, Legal, Supply Chain, External vendors
• Who is the executive sponsor or budget holder for safety system investments today? Options: Head of PV, CFO, Chief Medical Officer, Head of Regulatory, No clear sponsor, Other
• Describe your escalation path for high-priority or expeditable cases—who signs off, and how fast can they respond?
• How would you rate stakeholder confidence in your current systems' ability to prevent missed deadlines? Options: Very confident, Somewhat confident, Neutral, Somewhat concerned, Not confident

Signals, Success, and What 'Zero Misses' Actually Means

• Is 'zero missed expedited reports' a concrete KPI you track, or a rhetorical goal your team aspires to? Options: Formal KPI with targets, Tracked informally, Aspirational goal only, Not discussed
• Which metrics do you currently monitor to show compliance and operational health? Options: Missed/late reports, Time-to-submission, Case processing cycle time, Automation rate, Gateway success rate, Signal detection lead time, Audit findings
• How do you currently detect safety signals vs. false positives—what tools and thresholds are in place?
• Which dashboards or reports would you want on day one to feel confident compliance is maintained? Options: Missed deadlines dashboard, Expedited report queue, Gateway submission success, Signal heatmap, Reviewer workload and SLA tracker, Validation evidence pack
• What loss or harm threshold would make you treat a statistical 'signal' as actionable rather than noise?

Surges, Crises, and the Moments That Break Processes

• When volume spikes 3x–10x, what breaks first—and why hasn’t that fragility been fixed?
• Which recent surge events have you experienced (product launch, safety issue, litigation, market withdrawal) and how did your system perform?
• What SLAs or surge commitments do you require from a vendor during crisis periods? Options: Response time for critical issues, Guaranteed throughput increases, Temporary reviewer augmentation, 24/7 support, Audit and validation support, Other
• How do you currently scale reviewer capacity during surges (internal overtime, contractors, vendor support, automation)? Options: Internal overtime, Temporary contractors, Third-party vendor support, Reprioritization of cases, Automation/triage rules, Other
• What are the technical constraints that most limit your ability to scale quickly (licenses, API limits, gateway access, validation windows)?
• How do you validate vendor claims about surge handling and historical crisis performance? Options: Case studies, Reference checks, Proof-of-concept, SLAs in contract, Performance dashboards, Other

If We Could Build Your Ideal Safety Outcome Together

• If regulators never received a late report again, what organizational changes would that unlock for you?
• Which capabilities would be non-negotiable for you to achieve that guarantee? Options: Automated E2B generation, Global gateway coverage, Real-time deadline manager/escalation, Signal detection analytics, Traceable audit trail, Configurable workflows, Validation-ready evidence
• Which jurisdictions or specific health authorities are highest priority for you to cover first? Options: US (FDA), EU (EMA), UK (MHRA), Japan (PMDA), Canada (Health Canada), China (NMPA), Other
• What documentation or validation artifacts will QA/regulatory expect before accepting a new safety system? Options: Installation/Operational Qualification (IQ/OQ), Functional Validation (CSV), Traceability matrix, Gateway test evidence, User training records, SOP updates, Other
• What's a realistic timeline for you to commit to a pilot and initial deployment to materially reduce missed reports? Options: Immediate (30 days), 1–3 months, 3–6 months, 6–12 months, Longer / exploratory
• At 3, 6, and 12 months post-deployment, what measurable outcomes would convince you this was a success?

Next Steps: What Would Make This Conversation Valuable?

• If we leave this meeting with only one concrete deliverable, what must it be?
• Would you be open to a hands-on workshop where we run your redacted cases through the platform to demonstrate timelines and gateway behavior? Options: Yes — workshop with my team, Yes — but only with a subset of cases, Maybe — need internal approval, No
• Can you share a representative, redacted sample of cases or a recent expedited report dataset for a sandbox test? Options: Yes — will share within 2 weeks, Yes — will share after NDA, No — cannot share data, Unsure / need guidance
• Who else should be included in the follow-up deep-dive (names and roles)?
• What are the critical blockers that would prevent you from moving to a pilot in the next quarter? Options: Budget, Internal resource constraints, Validation timeline, Data access / integrations, Executive sponsorship, Other
• Preferred timing for a technical sandbox or proof-of-concept session? Options: Within 2 weeks, 2–4 weeks, 1–2 months, Later this quarter, Undecided

• Solution Experience: Prep & Current-State Alignment
• Solution Experience: Live Case Routing & Deadline Management
• Solution Experience: E2B Submission Simulation (Multi-Jurisdiction)
• Solution Experience: Signal Detection & Triage Using Customer Data
• Solution Experience: Validation, Acceptance Criteria & Next Steps

• Obtain customer sign-off on which signal types will be part of the formal validation.
• Customer to confirm escalation owners and desired alert cadence for the platform configuration.
• Session Goals & Preconditions
• Prove correct E2B content generation for the customer's cases across chosen jurisdictions.
• Demonstrate automated submission, validation response handling, and retry logic.
• Validate audit-trail and evidence collection meets regulatory inspection needs.
• Obtain explicit customer confirmation that the submission behavior satisfies their regulatory gatekeepers.
• Customer to provide sandbox HA endpoints/credentials or confirm seller-provided test endpoints.
• Seller to provide an E2B mapping summary per jurisdiction used in the demo.
• Customer to confirm any additional E2B flavors or local extensions required.
• Objectives & Metrics
• Show that the platform surfaces meaningful signals from the customer's dataset.
• Demonstrate end-to-end linkage from signal to case evidence and triage actions.
• Agree signal thresholds and baseline performance metrics for validation.
• Introductions & Objectives
• Customer to provide historical performance metrics (if available) and confirm which signal types are highest priority.
• Seller to run additional historical signal runs and deliver a performance summary for validation.
• Customer to nominate clinical reviewers who will validate surfaced signals during the validation window.
• Recap Proofs & Customer Confirmations
• Have an agreed, time-bound validation protocol with explicit pass/fail criteria.
• Lock acceptance criteria tied to regulatory compliance and operational metrics.
• Assign owners and schedule for validation execution and sign-off.
• Secure alignment to proceed to Mutual Commit and Deployment readiness when criteria met.
• Seller to deliver a written validation protocol and evidence template for the customer to review.
• Customer to confirm and sign acceptance criteria and provide legal/commercial contacts for Mutual Commit.
• Both parties to schedule the formal validation execution window and assign validation owners.
• Seller to prepare an evidence package format that satisfies inspection and audit requirements.
• Produce a one-sentence current state that all stakeholders accept.
• Quantify the consequence of current failures in measurable terms (time, regulatory risk, cost).
• Agree a clear one-sentence future-state outcome the experience must prove.
• Identify and commit delivery of representative real cases and sandbox access before live sessions.
• Assign owners and deadlines for all required prework artifacts.
• Customer to deliver 10–25 anonymized representative cases including at least one surge and one multi-jurisdiction case.
• Customer to provide list of active jurisdictions, reporting rules, and any special validations required.
• Customer to grant sandbox/gateway access or provide test endpoints and credentials.
• Customer to designate pharmacovigilance SME and IT contact for the live sessions.
• Seller to prepare mapped test scenarios and a one-page future-state statement to validate during demos.
• Recap Current State & Future State
• Demonstrate automatic timeline creation and SLA enforcement for the customer's cases.
• Prove that automated escalations prevent missed deadlines in the reviewed scenarios.
• Validate that exception handling meets the customer's surge and edge-case needs.
• Obtain direct customer confirmation that the workflow outputs match their expected future state.
• Customer to flag additional edge cases (if any) that must be shown in a follow-up routing demo.
• Seller to capture SLA mapping configuration and produce a one-page SLA control plan for customer review.
• One-Sentence Current State
• Run Live Signal Detection
• Map Case to Jurisdiction Rules
• Live Intake: Case Routing
• Review Proposed Validation Protocol
• Agree Acceptance Criteria & SLAs
• Map Signals to Clinical/Operational Consequences
• Timeline Generation & SLA Tracking
• Live Build: E2B Message Generation
• Quantify Consequence
• Roles, Responsibilities & Timeline
• One-Sentence Future State
• Escalation & Exception Handling
• Transmit to Sandbox Gateways
• Triage Workflow Walkthrough
• Dataset & Case Selection

• Adverse Event Case Intake and Triage
• Case Deduplication and Data Normalization
• MedDRA Coding for Events and Indications
• Medical Review, Causality Assessment and Narratives
• E2B ICSR Generation and Validation
• Automated E2B Submissions to FDA/EMA/Global
• Expedited Reporting Workflow with Deadline Escalations
• Periodic Safety Report (PSUR/PBRER) Generation
• Signal Detection Analytics and Statistical Monitoring
• Signal Management and Risk-Minimization Tracking
• Safety Database Hosting with Full Audit Trail
• Inspection-Ready Data Exports and Audit Package
• Computer System Validation and Validation Documentation
• End-User Training on Case Processing and Reporting

Adverse Event Case Intake and Triage

• Which intake channels do you require the platform to accept? Options: Phone/Paper, Email, Web form/Portal, EHR/EMR integration, Clinical trial eCRF, Third-party vendors/partners
• What is your average and peak monthly case intake volume? Options: Less than 100, 100-1,000, 1,000-5,000, 5,000-20,000, More than 20,000
• Do you require automated triage rules to prioritize serious/expedited cases? Options: Yes, No
• Which case prioritization criteria must be supported (select all that apply)? Options: Seriousness, Suspected product, Age group (e.g., pediatric), Reporter type (HCP vs consumer), Regulatory deadlines by jurisdiction, Other (specify)
• Do you need custom intake forms or structured data capture for specific products/studies? Options: Yes, No
• What turnaround time (SLA) do you expect for initial intake triage? Options: Within 1 business hour, Within 4 hours, Within 24 hours, Within 48 hours, Custom

Case Deduplication and Data Normalization

• Do you require automated duplicate detection across intake channels and legacy systems? Options: Yes, No
• Which identifiers are consistently available to support deduplication? Options: Patient initials/DOB, Medical record number, Reporter contact, No reliable identifier, Other (specify)
• What tolerance do you want for fuzzy-matching rules (name/address/narrative similarity)? Options: Conservative (low false merges), Balanced, Aggressive (reduce duplicate records), Undecided - need vendor recommendation
• Which data elements require normalization (select all that apply)? Options: Drug names (brand/generic), Dose units, Dates and times, Reporter roles, Concomitant medications, Other (list)
• Do you require a manual review queue to confirm or override deduplication matches? Options: Yes, No
• What duplicate rate (estimated) should we design capacity for? Options: Under 1%, 1-5%, 5-15%, Over 15%, Unknown - needs assessment

MedDRA Coding for Events and Indications

• Do you want automated MedDRA auto-coding, manual coding, or a hybrid workflow? Options: Automated only, Manual only, Auto-code with manual review, Hybrid - rules-based assignment
• Which MedDRA version policy should we support? Options: Always latest release, Fixed version (specify), Major version with quarterly updates, Customer-defined cadence
• Which coding scope is required for your use (select all that apply)? Options: Preferred Term (PT), Lowest Level Term (LLT), System Organ Class (SOC), Indication coding, Concomitant medication coding
• What is the expected language(s) of narratives that require coding? Options: English, Multilingual (specify languages), Primarily local language with English summaries, Other
• What SLA do you require for coding turnaround (e.g., initial code assigned)? Options: Within 1 business day, Within 3 business days, Within 7 business days, Custom
• Do you require audit trail and coder reconciliation workflows (second coder/medical review)? Options: Yes, No

Medical Review, Causality Assessment and Narratives

• Which causality assessment method should be supported? Options: WHO-UMC, Naranjo, Company-custom algorithm, Free text/No formal method
• Who will perform medical review and sign-off (roles)? Options: In-house physicians/medical officers, Contract medical reviewers, Shared responsibility with vendor, Other (specify)
• Do you require narrative templates or auto-generated narrative drafts? Options: Yes - templates only, Yes - auto-generated drafts for review, No
• What escalation criteria should trigger urgent medical review? Options: Death/Life-threatening, Hospitalization, Important medical event, Regulatory expedited criteria, Custom
• Do you require electronic signatures or attestation tracking for medical sign-off? Options: Yes (e-signature), Yes (simple attestation), No
• What target review timelines are required from initial intake to completed causality assessment? Options: Within 24 hours, 48-72 hours, Within 7 days, Custom

E2B ICSR Generation and Validation

• Which E2B specification(s) must the system generate and validate? Options: E2B(R2), E2B(R3) v2.x, Both R2 and R3, Other (specify)
• Do you require schema and business-rule validation prior to submission? Options: Yes - strict validation, Yes - warning-level validation, No - minimal validation
• Should supporting documents (e.g., redacted narratives, lab reports) be attached to E2B packages? Options: Yes - always, Conditional (serious cases only), No
• Do you require custom field mappings from your source systems to E2B fields? Options: Yes, No
• What is your tolerance for missing or incomplete fields during automated generation? Options: Zero tolerance - block submission, Allow submission with mandatory fields only, Allow and flag for manual completion
• Do you want automated validation reports and corrective action tracking for failed E2B files? Options: Yes, No

Automated E2B Submissions to FDA/EMA/Global

• Which jurisdictions/health authorities must the platform submit to? Options: FDA (US), EMA (EU), MHRA (UK), PMDA (Japan), Local authorities (specify), Other global HAs
• Do you already have submission gateway credentials/certificates for each HA or need vendor setup? Options: Customer has gateways/certs, Vendor to configure and maintain gateways, Hybrid - some customer, some vendor
• Do you need automated receipt/ACK processing and reconciliation? Options: Yes - automated, Yes - manual monitoring, No
• Will multiple Marketing Authorization Holders (MAHs) or affiliates be submitting from this instance? Options: Single MAH, Multiple MAHs/affiliates
• What monthly submission volume should the gateway and retry logic be sized for? Options: Under 100, 100-1,000, 1,000-5,000, 5,000+
• Do you require customized submission schedules or timed cutoffs for specific HAs? Options: Yes, No

Expedited Reporting Workflow with Deadline Escalations

• Which expedited reporting timelines and rules must be enforced? Options: US 15/7 rules, EU expedited timelines, Local HA-specific timelines, Clinical trial expedited rules, Other (specify)
• Do you require automated countdowns and escalation notifications for impending deadlines? Options: Yes - multi-channel (email/SMS/ITSM), Yes - email only, No
• Who should be included as escalation contacts and what escalation tiers are required? Options: Local safety team, Medical leadership, Regulatory affairs, Vendor support, Custom
• What SLA must the system meet for identifying and flagging missed-deadline risk? Options: Immediate (within 1 hour), Within 4 hours, Within 24 hours, Custom
• Do you need surge-handling rules (automated re-prioritization, additional reviewer pools) during safety events? Options: Yes - predefined surge plan, Yes - ad-hoc handling, No
• Should deadline escalation events generate auditable tickets or change control records? Options: Yes, No

Periodic Safety Report (PSUR/PBRER) Generation

• Which periodic report types do you need automated support for? Options: PSUR/PBRER, PADER, PSMF-related extracts, Aggregate safety reports (other)
• What reporting cadence do you require (e.g., quarterly, biannual, annual)? Options: Quarterly, Biannual, Annual, Custom
• Which data sources should feed the periodic reports (select all that apply)? Options: Safety database, Clinical trial databases, Literature surveillance, Sales/Exposure data, Other
• Do you require auto-populated narratives and sections in PSUR/PBRER drafts? Options: Yes - full drafts, Yes - data sections only, No - manual preparation
• Do you need regulatory region-specific annexes or templates included? Options: Yes - per HA templates, No - standard global template, Custom
• Should the PSUR generation include sign-off workflow and version control? Options: Yes, No

Signal Detection Analytics and Statistical Monitoring

• Which signal detection methods should be available out-of-the-box? Options: PRR, ROR, MGPS/EBGM, Disproportionality with stratification, Custom statistical models
• What historical data window should analyses use (e.g., 6, 12, 36 months)? Options: 6 months, 12 months, 24 months, 36+ months, Custom
• What thresholds/triggers should generate a signal alert (select all that apply)? Options: Statistical threshold breach, Increase from baseline, New seriousness pattern, User-defined rule, Other (specify)
• Do you require integration of external reference datasets (background rates, sales/exposure)? Options: Yes - pharmacovigilance benchmarks, Yes - commercial exposure data, No
• What output deliverables do you expect from signal detection (dashboards, scheduled reports, raw datasets)? Options: Interactive dashboards, Scheduled PDF/CSV reports, Raw data extracts, All of the above
• Do you need automated alert triage routing to specific users/roles? Options: Yes, No

Signal Management and Risk-Minimization Tracking

• Do you require a formal signal management workflow (detection -> triage -> assessment -> decision)? Options: Yes, No
• Which risk-minimization measures need to be tracked within the system? Options: Label changes, Dear Healthcare Provider letters, Restricted program management (REMS/RMM), Educational materials, Other
• Do you require linkage between signals and regulatory submissions/PSURs for evidence and auditability? Options: Yes, No
• What metrics or KPIs should be tracked for signal lifecycle (time-to-assessment, closure rate, action effectiveness)?
• Do you require stakeholder notification templates and decision logs for signal governance? Options: Yes, No
• Should the system support measurement of risk-minimization effectiveness over time? Options: Yes, No

• Non-Disclosure Agreement (NDA)
• Master Services Agreement (MSA)
• Statement of Work (SOW)
• Pricing & Payment Terms
• Service Level Agreement (SLA) - Standard & Surge
• Validation & Acceptance Test Plan (ATP)
• Regulatory Compliance & Audit Responsibilities
• Data Processing Agreement (DPA)
• Security & Hosting Addendum
• Implementation Schedule & Milestones
• Training, Support & Knowledge Transfer
• Change Control & Change Order Agreement
• Termination, Exit & Data Return Plan
• Intellectual Property & Licensing Terms
• Escrow & Business Continuity Assurance

• Quarterly Compliance & Regulatory Risk Review
• Operational Performance & SLA Review
• Signal Detection Performance & Prioritization Review
• Incident Retrospective & Corrective Actions
• Governance: Shared Issues & Enhancements Forum

• Publish final RCA and CAPA plan to the shared channel and regulatory team as required.
• Implement agreed escalation threshold changes and notify the support/ops teams.
• Schedule targeted training sessions for teams where process errors drove delays.
• Objective & Pre-work Confirmation
• Confirm the accuracy and operational performance of signal detection methods for the period.
• Prioritize candidate signals for formal investigation or other regulatory action.
• Set measurable changes to analytics or thresholds to improve future detection performance.
• Open investigation dossiers for signals approved for formal review and assign owners.
• Create analytics tuning tickets to adjust detection thresholds and schedule A/B testing.
• Run a retrospective analysis on any false positives to refine feature sets.
• Document required evidence for any signals that may trigger periodic or expedited reports.
• Retrospective Context & Goals
• Agree on a prioritized CAPA list with owners and measurable success criteria.
• Ensure there is a clear validation plan and evidence trail for each CAPA.
• Restore stakeholder confidence by documenting preventive controls and testing plans.
• Opening & Objectives
• Assign owners and dates for each CAPA and add verification tasks to the validation checklist.
• Schedule a verification test and evidence review to confirm CAPA effectiveness.
• Update runbooks and playbooks to reflect new preventive controls.
• Forum Objectives & Channel Rules
• Ensure a single, agreed-upon backlog with prioritization criteria tied to compliance and operational risk.
• Define and commit to triage/escalation responsibilities and SLAs for issue resolution.
• Schedule delivery windows for high-priority enhancements and assign owners.
• Update the shared ticket board with prioritized statuses and committed delivery dates.
• Create escalation contacts and publish the triage workflow in the shared channel.
• Open project plans for enhancements approved for the next quarter and assign PM owners.
• Publish a monthly governance summary for stakeholders summarizing progress and blockers.
• Confirm that all regulatory reporting obligations for the period were met or have approved remediation plans.
• Agree owners, timelines, and evidence required to close any compliance gaps or inspection findings.
• Ensure inspection packages and validation evidence are complete and accessible.
• Produce a consolidated compliance evidence packet for regulators and archive location.
• Assign remediation owners and deadlines for each high-risk compliance gap.
• Prepare regulator response drafts for any open queries and schedule reviews.
• Schedule follow-up check-in to confirm remediation progress prior to next quarter.
• Meeting Kickoff & Metrics Context
• Validate whether operational SLAs were met and identify causes for any breaches.
• Approve capacity or process changes to close performance gaps.
• Ensure owners are assigned for implementing operational improvements and surge plans.
• Update capacity forecast and resource plan to address identified shortfalls.
• Create action tickets for process automation opportunities with estimated impact on cycle time.
• Compliance Scorecard
• Signal Detection Metrics
• Core Ops Metrics Review
• Review Open High-Priority Tickets
• Timeline & Impact Summary
• Backlog Prioritization
• Root Cause Analysis
• Regulatory Correspondence & Inspection Updates
• Top Candidate Signals Walkthrough
• SLA & Escalation Performance
• Validation & Triage Decisions
• Audit Trail & Validation Evidence Review
• Corrective & Preventive Actions (CAPA)
• Root Cause Analysis for Variances
• Triage & Escalation Workflow
• Risk Heatmap & Prioritized Gaps
• Roadmap Alignment & Timelines
• Capacity & Resourcing Plan
• Validation & Evidence Requirements
• Analytics Tuning & Scope Changes