Medical and Regulatory Affairs

Speed vs Safety: How Regulators Are Sizing Up Evidence Today

In drug development, there is always pressure to move quickly, and with today’s push to develop treatments and vaccines for COVID, those pressures are exacerbated. From sponsors and investors to investigators and regulators, everyone is trying to balance the dual needs for speed and safety.

The places where they find success are likely to change drug development forever.

Adopting decentralized trials and embracing real-world data allows COVID (and other) trials to proceed at a time when typical site visits are fraught. Once global regulators are secure that even under these new circumstances, the data are still valid and clean, these processes are likely to be more widely implemented. In the meantime, sponsors should be confident about working closely with regulators to understand potentially shifting requirements and to build a strong regulatory strategy.

In this webinar, the speakers will ground their predictions for the future in the historic response of regulatory bodies to epidemics, then explore recent shifts in the regulatory environment in response to COVID and the resulting new efficiencies in drug development.

  • How to start the study in the shortest time possible, beginning with an assessment of what country or countries can offer the fastest start-up
  • Strategies for engaging patients, making your study more appealing, safe, and rewarding than competing trials
  • Accelerating the timeline from country selection to first patient screened
  • Evaluating protocol considerations to increase the overall feasibility of the study and optimize regulatory start-up timelines

Presented by:

Linda McBride, Executive Director, Regulatory Affairs and Compliance Regulatory Professionals, a division of Premier Research

Daniel Semere, Senior Regulatory Submissions Manager