What are the key issues with regards to pharmacovigilance and risk management in pharma industry?
One of the Key Issues is for Pharmaceuticals and Biotech Companies to respond to FDA within the stipluated time period for events such as SUSAR’s . Specially in cases of multiple trial sites and clinical trials going global the ability to collate data and convert it to information for FDA with a proper medical assessment to be completed within a short time frame becomes a challenge .
