Regulatory Science & Policy

The regulatory environment in 2027 is defined by accelerated approval reform under FDORA, the rolling implementation of the Inflation Reduction Act's Medicare drug price negotiation, and ongoing harmonization through ICH. WCPD 2027 will cover the FDA's post-Aduhelm tightening of confirmatory trial requirements, the new pre-approval inspection expectations for cell and gene therapy facilities, and the EMA's parallel moves on PRIME and conditional marketing authorization. Sessions will also examine the IRA's impact on R&D portfolio decisions, the small-molecule vs biologic price-negotiation timeline asymmetry, PBM reform proposals, and the global divergence on AI/ML-enabled software as a medical device.