A risk management plan (RMP) describes the
current knowledge about the safety and efficacy of
a medicinal product and provides key information
on plans for studies and other activities to gain
more knowledge about the safety and efficacy of
the medicine.
It also describes measures to be undertaken to
prevent or minimize risks associated with the use of
the product and effectiveness of those measures.
The MAHs are required to submit RMP to the
European Medicines Agency (EMA) when applying
for a marketing authorization.
The overall aim of risk management is to ensure
that the benefits of a particular medicinal product
exceed the risks by the greatest achievable margin.
The primary aim and focus of the RMP remains that of
appropriate risk management planning throughout a medicinal product’s life cycle. The risk management
system shall be proportionate to the identified risks and the potential risks of the medicinal product, and the need for post-authorization safety data.
The RMP is a dynamic document that should be updated throughout the life cycle of the product(s).
Soterius can support sponsors in the following activities relevant to the RMP process:
Local Risk Management
Preparation, review and archival of RMPs as per applicable regulatory requirements.
Provide support in responding to any post submission regulatory authority requests regarding the RMP.
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