Webinars

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Leveraging Real World Evidence to Drive Patient Access and Affordable Care


Madhur Garg

Real World Data (RWD) is defined as data collected outside the controlled constraints of conventional randomized clinical trials to evaluate what is occurring in routine clinical practice. One of the characteristics of RWD is large sample size along with heterogeneity which needs...

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A Pragmatic Way to Navigate the Safety-Regulatory Continuum for Mature Products


David Balderson

In the face of dwindling drug pipelines, stringent drug regulations, and block-busters crossing their patent exclusivity, mature and established products offer an opportunity for companies to sustain their revenues and bottom lines in the increasingly challenging pharmaceutical market. Compared to new products,...

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Safety Operations Expert Panel Discussion: A New Approach to Ensuring Quality Safety Submissions the First Time


David Balderson

Poor quality ICSR data impacts the ability to conduct safety surveillance activities and forces regulators and independent groups to question the overall quality of the pharmacovigilance system. Learn best practices and recommendations that can be employed to improve case quality, avoid feedback...

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