DIA India 9th Pharmacovigilance Conference: Evolving Safety Ecosystem – Pharmacovigilance for tomorrow

Managing patient safety during clinical trials is an unalienable component throughout the drug development life cycle. Considering the drug development life cycle to be similar to a 4X100 meter relay where the “baton” that is passed in every leg of the race is Safety, and if the “baton” is dropped then the race is lost. Therefore all parties involved in clinical development of therapies must work both proactively and collaboratively with all stakeholders to ensure a systematic and transparent approach to safety monitoring (seamless baton passing) . There has been a rapid transition from passive to active safety surveillance activities in recent years, and that transition is accompanied by a need for more comprehensive and innovative approaches that apply quantitative methods to accumulating and qualitative methods to analyzing data from clinical trial sources.