Scenarios

Master the critical distinction between severity and seriousness

Apply causality assessment principles to complex cases

Determine expectedness using Reference Safety Information

Recognize patterns that may indicate emerging safety signals

Practice responding to common inspector questions with confidence

Handle inspector document requests and navigate common inspection scenarios

Practice identifying valid cases from consumer phone reports

Evaluate a tricky email that may or may not contain a valid case

Identify reportable cases from published medical literature

Identify embedded adverse events in product inquiries

Identify reportable adverse events from social media monitoring

Process a Serious Adverse Event from a clinical trial setting

Practice determining correct reporting timelines for different scenarios

Manage follow-up information and determine when new reports are needed

Navigate different reporting requirements across regulatory regions

Triage and process a potential AE mentioned on the company's social media channel.

Ensure FDA E2B(R3) mandate (April 2026) is met and handle a late upgrade.

Use real-world data appropriately in a signal evaluation and document fitness for use.

Design and explain effectiveness evaluation for an aRMM (GVP XVI Addendum II).

Apply GVP VI Addendum II masking rules before submitting to EudraVigilance.

Address a finding from a mock inspection (training record gap).

Submit a serious domestic ADR to PvPI and CDSCO from your Mumbai office.

Decide whether two reports are the same case and handle linking.

Decide if a case is expedited (serious, unexpected) and set Day 0.

Process a case from a published paper and submit as ICSR.

Handle follow-up that upgrades a case to serious and triggers expedited reporting.

Respond to a regulatory request for a signal validation report.

Answer inspector questions on validation of your safety database.

Interpret PRR and decide next step (validate vs dismiss).

Explain REMS and ETASU to an inspector (FDA).

Present PSMF and keep it current.

Triage a call from medical information that mentions an AE.

Design case intake to collect only necessary data (GDPR data minimization).

Ensure PBRER reflects current benefit-risk and is not copy-paste.

Demonstrate oversight of outsourced case processing.

Address potential bias in AI used for case triage.

Stay updated with NCC-PvPI and CDSCO PV requirements.

Process a fatal case and request autopsy information.

Reconcile internal database with EudraVigilance submissions.

Apply ICH E2D(R1) definitions for post-approval safety data.

Handle a pregnancy case that is also in your company pregnancy registry.

Respond to inspector request for sample cases and SOPs.

Navigate ethical use of AI in signal detection and inspector questions on transparency.

Respond to an inadvertent disclosure of patient data and regulatory expectations.

Prepare for and respond during a CDSCO PV inspection in Mumbai.

Validate a signal using internal methodology equivalent to EMA expectations.

Handle a pregnancy exposure case and obtain birth outcome per GVP and company process.