Communicating with Regulatory Agencies, Business Partners, Healthcare facilities & Media Communication with Media: Who are the media? Print -magazines, newspapers, community newspapers Electronic -radio, TV, internet Local and national levels Some basic questions a reporter will ask […]
Definition of Crisis: Any event that comes to public notice and threatens the health or safety of individuals or groups, or the reputation or stability of an organization. Crises usually erupt suddenly and dramatically; they require rapid and effective response […]
Communication: The act of sharing or exchanging information, ideas or feelings. Principles of Good Pharmacovigilance Communication Relate the messages to the audience’s perspective Avoid comparisons which trivialize the concern Ensure completeness of the message Be balanced, […]
Targeted clinical investigations When significant risks are identified from pre-approval clinical trials, further clinical studies might be called in to evaluate the mechanism of action for the adverse reaction. In some instances, pharmacodynamics and pharmacokinetic studies might be conducted to […]
CROSS SECTIONAL STUDIES These are primarily used to determine prevalence. Prevalence equals the number of cases in a population at a given point in time. All the measurements on each person are made at one point in time. Prevalence is […]
Comparative observational studies- Case control study is one of the type of Comparative observational studies. CASE-CONTROL STUDIES In contrast with cohort and cross sectional studies, case control studies are usually retrospective. People with the outcome of interest are matched with […]
Cohort, cross sectional, and case-control studies are often referred to as observational studies because the investigator simply observes. No interventions are carried out by the investigator. With the recent emphasis on evidence based medicine and the formation of the Cochrane […]
Ball and Socket Joint The ball and socket joint (or spheroid joint) is a type of synovial joint in which the ball-shaped surface of one rounded bone fits into the cup-like depression of another bone. The distal bone is capable of motion around […]
Pharmacovigilance Methods Active Surveillance Active surveillance, in contrast to passive surveillance, pursues to determine the particular number of adverse events through a constant pre-organized process. In common, it is more achievable to acquire wide-ranging data on discrete adverse event reports […]
I. Passive surveillance • Encompasses all spontaneous AEFI reporting • from immunization service providers / hospitals / patients •Up to next levels: state/territory then national (TGA) and then global a) Spontaneous reports A spontaneous report is a voluntary communication by […]