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Drug Safety: A Continuum Approach Linking Pre-Market and Post-Market Safety Assessment
Session Chair(s)
Susan Mayo, MS
Senior Mathematical Statistician, CDER Office of Biostatistics
FDA, United States
Seating is limited.
Pharmaceutical Drug Safety is of paramount importance to drug manufacturers, payers, regulators, and the society as a whole as it attracts public attention more so than effectiveness. While there have been significant efforts in monitoring safety thru internal safety groups within the drug manufacturers and independent external committees in the clinical development phase, not a lot of these pre-marketing safety information may be historically translated into a robust pharmacovigilance (PV) and safety monitoring plan in the post-marketing arena. The EMA GVP regulations encourage good PV planning during clinical development but at this stage have not offered recommendations. In order to provide more clarity into potentially suspected safety issues during the clinical trials, follow-up post-marketing real world evidence (RWE) studies could be undertaken. On behalf of the DIA/ASA Biopharm Safety Evaluation Scientific Working Group, currently focusing on safety monitoring during development, it would be important to discuss the possibility of bridging with the post-marketing safety planners in an informal interactive dialogue with subject matter experts in the PV, RWE and Safety area to plan for future collaborations in this important aspect of life-cycle of pharmaceutical drugs.
Learning Objective : Explain the planning objectives of the ASA Biopharm/DIA Safety Monitoring Assessment Scientific Working Group (SWG); Discuss ways to bridge pre-marketing safety planning recommendations of this SWG to safety planning in post-marketing.
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