Pharmaceutical companies, clinical researchers and scientists are investing time and resources to innovate processes for
developing safe and effective medicines with risks minimized and benefits maximized. The discoveries in
pharmaceutical medicine over the last few years have transformed the canvas of healthcare. Like the coin
has two sides, the industry has seen successes and suffered qte significantly in certain situations
leading to qte a few product recalls and heavy penalties to some of the world renowned pharmaceutical
companies. Pre-approval clinical studies that run through phase 1 to 3 are conducted to evaluate safety
and efficacy of the medicine in development. The safety profile that develops during this transition will
be included into the Investigator’s brochure (reference document for product safety) and any serious adverse event,
as defined by the health authorities, that is identified new will have to be reported by the sponsor of the study
to the health authorities on an expedited basis and also the information has to be passed onto all investigations sites.
Timely identification of such events and alerting all stakeholders is crucial for the safety of the patient. Vigi Medsafe is highly experienced in such activities of identification of such safety events and alerting relevant stakeholders through appropriate procedures (generating SUSARs, INs etc) Even though the risk profile is fairly developed by the time authorization is granted for a particular medicinal product, there are many rare events and events that have longer latency periods that will be detected much later in the post-marketing phase. The information on risk events will be made available through periodically updated labels such as Summary of Product Characteristics (SmPC) or Prescribing Information (PI). There will be unsolicited, spontaneous reports from various sources like the healthcare professionals, lawyers, media etc. Any new event that is not mentioned in the SmPC or PI has to be reported to the health authorities on a timely manner. Vigi Medsafe has highly trained and experienced
workforce to analyze such events and has delivered (reporting to health authorities and updating labels) successfully in the past.