GVP Module XV: Safety Communication

Detection of any signal automatically requires an immediate variation A signal should never affect product information until a clinical trial confirms causality A signal prompts assessment of whether current product information reflects the evidence, but does not automatically determine the regulatory outcome Product information is unrelated to safety-signal management

Brand visibility, marketing budget and expected media coverage Seriousness, frequency, preventability, affected population, uncertainty and consequences of misunderstanding Number of employees available to draft the communication Whether the safety issue has already appeared on social media

Whenever any internal email mentions a safety issue When it forms part of risk minimisation or additional pharmacovigilance activity with a defined objective and implementation process Only when it is published in a scientific journal Never, because communication is separate from risk management

Urgency of the safety issue Audience and required action Complexity of the information The channel most convenient for the communications department

Wait until causality is proven before communicating under any circumstances State that the product causes the event so that the audience takes the issue seriously Communicate the observation, the current assessment, relevant uncertainty and interim action Avoid discussing the evidence and provide only a general reassurance

As proof that the medicinal product has become more toxic As proof that the communication failed As a finding that may reflect increased awareness or reporting behaviour and requires contextual assessment As evidence that the product should automatically be withdrawn

Continue using provisional wording until the next periodic report Ensure downstream materials and relevant internal functions accurately reflect the approved regulatory position Withdraw all communications, including those that remain accurate Allow each affiliate to decide whether the decision affects its materials

The desired preventive behaviour and evidence that could demonstrate improvement The number of recipients who opened the email only The amount of media coverage generated The preferred wording of the corporate communications team

Aggregate evaluations cannot generate communication needs Communications may both arise from changes in the safety profile and influence later reporting or exposure data PSURs replace the need for communication once submitted Communication events should be excluded from interpretation of subsequent safety data

Every signal requires immediate public communication Signal management and communication are unrelated processes A signal may require internal escalation without public communication, while an established risk may require communication without a new signal Communication can occur only after a signal has been closed