Scenarios

Identify embedded adverse events in product inquiries

Handle inspector document requests and navigate common inspection scenarios

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

Respond to a regulatory request for a signal validation report.

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

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

Stay updated with NCC-PvPI and CDSCO PV requirements.

Recognize patterns that may indicate emerging safety signals

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

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

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

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

Reconcile internal database with EudraVigilance submissions.

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

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

Explain REMS and ETASU to an inspector (FDA).

Demonstrate oversight of outsourced case processing.

Apply causality assessment principles to complex cases

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

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

Triage a call from medical information that mentions an AE.

Address potential bias in AI used for case triage.

Navigate different reporting requirements across regulatory regions

Identify reportable adverse events from social media monitoring

Practice determining correct reporting timelines for different scenarios

Process a Serious Adverse Event from a clinical trial setting

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

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

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

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

Answer inspector questions on validation of your safety database.

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

Identify reportable cases from published medical literature

Determine expectedness using Reference Safety Information

Present PSMF and keep it current.

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

Process a fatal case and request autopsy information.

Practice responding to common inspector questions with confidence

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

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

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

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

Respond to inspector request for sample cases and SOPs.

Practice identifying valid cases from consumer phone reports

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

Master the critical distinction between severity and seriousness

Validate a signal using internal methodology equivalent to EMA expectations.