Tag Archives: Pharmacovigilance
TGA Inspections are Coming – Is your Company Ready?
The TGA has recently concluded its pilot program in Pharmacovigilance inspections in Australia. Numerous companies volunteered to take part in this inspection program, and from those volunteers the TGA selected ten companies. The selection process by the TGA considered a) … Continue reading
New Zealand Pharmacovigilance Guidelines Edition 2, effective in the New Year
In April this year, Medsafe released the new draft guidelines for pharmacovigilance (PV) in New Zealand. Interested parties were invited to provide comment and Medsafe provided feedback on these on their website. Part 8 of the Guideline of Therapeutic Products … Continue reading
Commercial Eyes joins Medicines New Zealand
While Commercial Eyes has been providing a full range of services to our clients across the Tasman for a number of years we have now highlighted our commitment to New Zealand by recently joining Medicines New Zealand. Two of our … Continue reading
A PV database to meet your needs… and your budget
Just as medicines and medical devices are held to stringent quality controls, so too is the software used to support the safety and efficacy of those same medicines and medical devices. Choosing a pharmacovigilance (PV) database for your business can … Continue reading
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
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
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
Medical Services Grows and Diversifies
Commercial Eyes’ Medical Services manager, Deidre Voss, brings her experience in process systems quality to an ever-expanding and increasingly diverse service offering. Continue reading
Risk Management Plans and Detailed Descriptions of PV Systems
We assess the complex area of Detailed Description of the Pharmacovigilance System components and show how sponsors can manage their vital requirements effectively. Continue reading
The Role of a Qualified Person for Pharmacovigilance
Commercial Eyes acts as the Qualified Person (QP) for many of its clients. Here, we review the TGA’s description of a QP and explore sponsors’ and QPs’ obligations. Continue reading