Evaluating Regulatory Trends Globally and Regionally
Sarah Hardison, head of Regulatory and Pharmacovigilance Solutions, Clarivate Analytics, will regulatory tackle trends in her presentation on the World of Pharma Podium during the second day of CPhI Worldwide.
As industry witnessed the highest ever number of new drug approvals by FDA in 2018 and with overall drug evaluations and launches increasing on a global scale thanks to increased R&D productivity, various regulatory trends and evolutions are inevitable. Sarah Hardison, head of Regulatory and Pharmacovigilance Solutions, Clarivate Analytics, will look to tackle these trends in her presentation on the World of Pharma Podium during the second day of CPhI Worldwide.
Global pharma pipelines are becoming more focused on rare diseases and unmet medical needs. As a result of this trend and the various advances in drug technologies, regulatory guidelines have needed to adapt to allow for approvals in cases where there is less evidentiary data.
In her presentation, Hardison will discuss both global and regional trends impacting the regulatory landscape, such as global harmonization, real-world data, next-generation biologics manufacturing, and generics and biosimilars.
Global Regulatory Outlook and Regional TrendsWednesday Nov. 6, 2019 11:00–12:00 World of Pharma Podium (80B10)
Drug Shortages and Complying with FDA’s 21 CFR 211.110 Guidance
April 2nd 2025Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.
