What are the pharmacovigilance tools that will be required for SEBS?
When? How often? A priority for participants with regard to pharmacovigilance is the trackability and traceability of specific products. They say it is important to have good records of who is taking which biologics and which patients have switched between different biologics in the same class. Education of health care providers and patients is mentioned by two tables as an important element of post-market oversight and risk management. Participants also mention PSURs as important pharmacovigilance tools. Two tables suggest that PSUR frequency should be aligned with ICH requirements and tailored to the risk associated with the product. Question 4: How will these be aligned with international regulatory partners? There is overall support for some harmonization/alignment with other jurisdictions. The two key points of alignment would be: • safety data sharing between governments using compatible data formats; and • coordination of reporting periods and timelines. The ICH was specifically
