As the expectations of regulators pivot from detailed description of adverse events to the conclusions of structured benefit risk analysis (sBRA) and planning of risk managment, Phlox PVMed Consultancy can offer
- support, training and mentorship to less experienced Pharmacovigilance teams planning their first RMP, Clinical Overview and Summary of Safety
- rapid review and documentation of a new or evolving safety signal within the framework of benefit risk assessment
- advanced comparative benefit risk with standard therapy or main competitors for regulatory communication or investor due diligence
- full assessment of current PV process against updated regulatory requirements
- departmental and cross functional team training on sBRA
- faciliation of sBRA kick off meeting for product teams