GVP Module XV: Safety Communication

Delay communication until all uncertainty has been eliminated Communicate rapidly when delay could affect patients, while clearly describing the evidence and remaining uncertainty Issue an unreviewed message immediately whenever media interest is high Communicate only after a final regulatory decision, regardless of risk severity

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

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

Only the final published message and a screenshot of its webpage The initiating assessment, decision rationale, approved content, review records, distribution evidence, implementation records and effectiveness results where applicable Only email correspondence between the communications team and the vendor Only the product's current promotional materials

Distribution records are never relevant to pharmacovigilance Delivery confirms reach but does not show whether the message was understood or acted upon Effectiveness can only be assessed through spontaneous adverse-event reports Only regulators can determine whether a communication was effective

It is primarily intended to support product promotion It communicates important safety information where specific action is required or recommended It is used only after a risk has been removed from the product information It must contain the same wording as every patient communication

Because translated materials must be longer than the source document Because a translation can alter the meaning, certainty or intended clinical action if not appropriately controlled Because only translators may approve the scientific conclusion Because translation eliminates the need for national implementation review

Use an urgent pathway with defined initiation, review, distribution and escalation responsibilities Release an unapproved message and document it later Wait for perfect certainty regardless of the risk Allow each Member State function to issue independent messages

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

It should change the underlying scientific conclusion to suit the audience It should change the level, format and terminology while preserving the underlying scientific meaning It should use identical wording for all audiences to prevent any variation It should omit uncertainty for patients and healthcare professionals