Risk Management Plans: reassessment of safety concerns based on Good Pharmacovigilance Practices Module V (Revision 2)-a company experience.

Suzan EsslingerLinda QuinnSami SampatMarijo Otero-LobatoWim NoëlAnja GeldhofNicole HerijgersSarah-Jane Reeder

Published in: Journal of pharmaceutical health care and sciences (2022)

The algorithm-driven process allows for consistent interpretation and application of the GVP Module V (Rev 2) guidance, which enables product teams to develop an actionable RMP using a thoughtful, evaluative, science-based approach that considers all available evidence.

Keyphrases

total knee arthroplasty
primary care
healthcare
public health
machine learning
deep learning
adverse drug
total hip arthroplasty
drug induced
neural network
electronic health record