Most drug developers seek new drug approvals in both the U.S. and Europe as they are two of the largest markets. However, considering both entities have some of the most evolved regulatory guidelines, approvals in the U.S. and Europe are often complicated by different policies, making simultaneous submissions of drug applications to multiple health authorities difficult and inefficient. Steve Sibley, VP of Synchrogenix Regulatory Science at Certara shares his expert opinion on the biggest risks and rewards when pursuing simultaneous drug application submission and talks about the differences and commonalities between the FDA and EMA, and reviews frequent missteps to avoid that can streamline the submission and potential approval success.
Steve Sibley has 30+ years of pharmaceutical experience focused on regulatory writing, consulting, and project leadership roles. He has successfully supported projects from discovery through approval and life cycle management. He has played significant roles in 75+ submissions and, in several cases, led the entire submission team, overseeing all documentation from Modules 1-5, publishing, and transmission to the regulatory authority.