Description: Successfully advancing drug candidates requires a globally aligned regulatory strategy that accounts for region-specific requirements and expectations. This session will focus on developing a robust global clinical trial application whilst understanding divergent expectations from various health authorities.
Participants will compare and contrast key areas of focus from particular regions (e.g. US, EU, Asia), level of scrutiny, and how to anticipate regulatory challenges. Discussion on how best to align clinical, nonclinical and CMC documentation across regions (pre and post approval) and minimize/anticipate requests for information will be initiated to expeditiously advance investigational products in areas of high unmet medical need.
Learning Objectives:
Participants will learn and share key differences and similarities in regulatory expectations from various global health authorities (e.g. US, EU, Asian). Recent trends and key topics of interest from clinical trial application reviews will be shared.
Participants will learn ways to proactively develop a global CTA , anticipate potential questions and minimize region specific changes.
Participants will learn strategies on how best to integrate regional/country-specific changes post approval.
