Germany

PV teams should review and potentially update their workflows, particularly in signal management and communications in light of the Bulletin's recommendations and insights.

PV teams should ensure that training on adverse reaction reporting is current and communicate the importance of the #MedSafetyWeek campaign. Update workflows and SOPs related to signal management and literature surveillance to reflect the emphasis on consistent documentation and timely reporting of suspected adverse reactions.

Teams should ensure compliance by reviewing and updating Standard Operating Procedures (SOPs) related to signal management and safety surveillance. Additionally, knowledge on PRAC recommendations from July to September 2026 must be integrated into ongoing assessments.

PV teams should update workflows to ensure compliance with the new reporting emphasis, implement clearer protocols for capturing adverse reaction reports, and communicate these obligations to healthcare professionals within their organizations.