Regulatory experience of handling risk management plans (rmps) for medicinal products in the EU
D Butler, K Vucic, S Straus, A Cupelli… - Expert Opinion on …, 2021 - Taylor & Francis
ABSTRACT Introduction: Risk Management Plans (RMPs) aim to optimize a medicinal
product's benefit/risk balance for the individual patient and the target population. Despite …
product's benefit/risk balance for the individual patient and the target population. Despite …
[PDF][PDF] Implementation of the new EMA methodology of defining risks and the HaRP methodology in the EU Risk Management Plan for Ibuprofen 40 mg/mL oral …
V Kostovski, I Dukovska, IT Aleksovska, A Kuzmanovski… - bulletin.mfd.org.mk
Risk is associated with every single aspect in pharmaceuticals from development of a
molecule to its way to the customer (Trivedi et al., 2016). The purpose of the risk …
molecule to its way to the customer (Trivedi et al., 2016). The purpose of the risk …