Pharmacoepidemiology

Lifecycle Risk Management Planning

Risk management planning has to be a lifecycle activity, commencing well before entry into man and finishing only after the product is not on the market anymore.

We have designed and implemented integrated safety risk management solutions for companies of various sizes, from single product biotech to international top-10 pharma companies, focussing on approaches that maintain knowledge about drug safety issues, enable the prioritisation of safety issues as important risks, allow for the simple generation of RMP documents (development RMPs, company core RMPs, EU-RMPs, REMs and other types of RMP as required in various parts of the world), and integrate information on the effectiveness of risk minimisation into the risk knowledge base. These approaches have successfully contributed to more transparent decision making about risks and the associated risk management and pharmacovigilance measures.