Ashfield Pharmacovigilance will host a live webinar that will focus on the differences between clinical and post market medical review.
Ashfield Pharmacovigilance will host a live webinar that will focus on the differences between clinical and post market medical review. The live broadcast will take place on Wednesday, March 30, 2016 at 11:00 am EDT (4:00 pm BST/ UK GMT +1), featuring industry expert Margaret McCulloch, Medical Director at Ashfield Pharmacovigilance as the presenter. Dr. McCulloch will begin by outlining the importance of choosing the most suitable physician as a medical reviewer in relation to safety monitoring.
It is crucial to keep in mind that the qualities and expertise that this key safety team member will be called upon to provide will differ depending on the particular safety scenario the company is facing. Knowing what is required and expected of the safety medical reviewer in these differing circumstances, and what factors determine the best choice, is integral to the overall smooth performance of the safety team.
There are two major categories of safety monitoring: “Clinical” which refers to safety monitoring of clinical trials and “Post-marketing”, safety monitoring of situations following approval and marketing, other than directly associated with clinical trials.
For both scenarios, monitoring consists of four basic elements: receiving safety information; processing and recording information; reviewing and analyzing information; and, lastly, acting upon information. The good safety medical reviewer is involved in all aspects of the safety cycle, although the level of involvement, and the specific tasks, may vary, depending on whether the scenario is clinical or post-marketing.