Continuing with our series on the current pharmacovigilance industry we spoke with Robin Geller, Director of Risk Management and Safety Writing Global Pharmacovigilance, at Baxter Healthcare Corporation
What is the biggest change that you are seeing in pharma's drug safety strategies at the moment?
The continuing shift from submission of individual case reports to aggregate analysis, signal detection and risk management. The implementation of these new processes has required the development of new methodologies and tools as well as greater cooperation between drug safety and other business functions.
What are the key challenges that pharma faces in effective benefit/risk communication?
There are several significant challenges for Pharmacovigilance functions. First, the analysis of benefit is not a topic generally undertaken by safety organizations. Thus there is a need to build a greater level of cooperation with clinical teams to develop and maintain robust benefit analyses. Then, there needs to be the development of generally accepted tools and methodologies for collecting and communicating information about benefit and risk both to regulators and the health care professionals. Finally, there also needs to be validated measures, taking into account both benefit and risk, that can be used for treatment decision making as well as for product approvals.