Risk management

Provide background information for Risk Management

Are you applying for a marketing authorisation and required by the EMA to submit a risk-management plan (RMP)? You will need a lot of information on a drug’s safety, plans for risk prevention or minimisation, proposed studies for post-marketing safety and efficacy, risk factors for adverse reactions and measurements to assess the effectiveness of your risk minimisation measures. PHARMO’s distinctive competence is extensive experience with designing, conducting and coordinating post-authorisation safety and effectiveness studies. The set up of the PHARMO Database Network is appropriate for risk management studies and evaluation of risk minimisation measures. Through the unique linkage of patient-centric data from various healthcare providers, we can create a complete profile of a patient’s medical history throughout their life, providing supportive information on whether there is a drug safety issue related to a specific drug or drug class. We can assist you with RMPs, contact us for more information.