Guideline on good pharmacovigilance practices (GVP) Module XV – Safety communication (Rev 1):
Introduction:
XV.B. Structures and processes
XV.B.1. Objectives of safety communication
XV.B.2. Principles of safety communication
XV.B.4. Content of safety communication
XV.B.5. Means of safety communication
XV.B.5.1. Direct healthcare professional communication (DHPC)
XV.B.5.2. Communication materials from competent authorities targeted at
healthcare professionals
XV.B.5.3. Documents in lay language to patients and the general public
XV.B.5.6. Social media and other online communications
XV.B.5.7. Bulletins and newsletters
XV.B.5.8. Inter-authority communication
XV.B.5.9. Responding to enquiries from the public
XV.B.5.10. Other means of communication
XV.B.6. Effectiveness of safety communication
XV.B.7. Quality system requirements for safety communication
XV.C. Operation of the EU regulatory network
XV.C.1. Coordination of safety announcements in the EU
XV.C.1.1. Process for exchange and coordination of safety announcements
XV.C.1.2. Exchange of safety information produced by third parties
XV.C.1.3. Requirements for the marketing authorisation holder in the EU
XV.C.1.4. Consideration for third parties
XV.C.1.5. Languages and translations
XV.C.2. Direct healthcare professional communications (DHPCs) in the EU
XV.C.2.2. Translation and dissemination of DHPCs
XV.C.2.3. Publication of DHPCs
GVP Annex II – Templates: Direct Healthcare Professional Communication
GVP Annex II – Templates: Communication Plan for Direct Healthcare Professional Communication