Managing health authority requests and assessment reports
Interactions with health authorities have the potential to generate new requests and commitments. PSUR/PBRER assessment reports in particular require follow-up activities that can span even years into the future. Safety commitments can be challenging to address since they require work across pharmacovigilance, risk management, and safety surveillance functions– all while residing with Regulatory Affairs.
Join Katherine Long and Kevin Fetterman from the Orbit Team on August 31 as they discuss Orbit’s innovative approach to managing safety commitments and health authority requests.
Access the Recording
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