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Global PV updates, mapped to your role.

Safety, regulatory, device, AI/GxP and compliance updates with role-specific action guidance for QPPV, Signal, Labeling, PV Ops and Device Vigilance.

Updates
25+ this week
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13
Workflows
15
Regulators
FDA · EMA · TGA · HC · WHO
Role: Labeling LeadWorkflow: Local Affiliate ComplianceUrgency: high

Latest role-filtered intelligence

Country GuidesHealth CanadaCanada

Health Canada updates RMP submission guidance effective 1 July 2025

Relevant for
Local Safety OfficerSignal Management LeadLabeling LeadRegulatory Intelligence Lead+3 more
Action needed

1) Retrieve and review the updated “Submitting risk management plans guidance document” (PDF) and linked templates referenced from the overview (e.g., RMP note to reviewer, Canadian-specific addendum, RMP summary template) and map deltas vs the superseded 2015 approach. 2) Update Canada submission checklists/work instructions for the 1 July 2025 effective date, including the requirement that the RMP include a summary in English and French and use of the RMP summary attestation/acknowledgment form. 3) Ask Regulatory Intelligence/RA to brief PV leadership on the Agile Licensing notice timeline (RMP provisions in force 1 April 2027) and confirm how transitional provisions will be operationalized for existing RMPs submitted prior to that date.

Process impact
Label GovernanceRisk ManagementLocal Affiliate Compliance
SOP impact

5 SOPs may need review

Urgency: HighConfidence: high
Read impact brief
Company Watch

Lilly acquires Engage Bio; Hanmi–Organon Southeast Asia supply deal

Relevant for
QPPVLocal Safety OfficerLabeling LeadPV Operations Lead+3 more
Action needed

This update requires triage for Local Affiliate Compliance, ICSR Submission, Vendor Oversight; confirm local obligations and document follow-up actions.

Process impact
Local Affiliate ComplianceICSR SubmissionVendor Oversight
SOP impact

4 SOPs may need review

Urgency: HighConfidence: medium
Read impact brief
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