Tag Archives: Drug Safety
Risk minimisation activities: What you need to know
Risk minimisation activities are required for each safety concern of a product listed in a Risk management Plan (RMP). These are interventions that aim to optimise the benefit-risk balance of a drug by minimising its risks in clinical practice. Risk … Continue reading
Risk Management Plans: Advice from the TGA
Members of our Drug Safety team were very interested to hear from the TGA at the 2015 ARCS Scientific Congress on the issue of Risk Minimisation Plans. Risk Management Plans (RMPs) are deemed necessary given that clinical trials generally cannot … Continue reading
Avoid Safety Data Exchange Agreements headaches
Safety Data Exchange Agreements (SDEAs) are an integral part of the collaboration we see in the pharmaceutical industry these days. Where multiple companies work together to develop and market drugs and devices, large amounts of information are collected by a sometimes … Continue reading
top 5 essentials to a seamless medical information transition
Partnering with a Medical Information services provider is a great way for you to focus your limited resources on key areas of your business. However, it’s important to give due consideration – as early as possible – to how the … Continue reading
Commercial Eyes recruiting: Drug Safety Coordinator
Commercial Eyes is recruiting a fulltime Drug Safety Coordinator. Based conveniently in the Melbourne CBD, the successful candidate will lead the Drug Safety team and provide protocol driven safety monitoring programs and pharmacovigilance services. For more information see our Drug … Continue reading
Pharmacovigilance Update
We look at how the TGA has made changes in the past year to strengthen pharmacovigilance through The Advisory Committee on the Safety of Medicines (ACSOM). Continue reading
