Keynote: From Molecule to Milestone – Accelerating Clinical Pharmacology Submissions Through Project Management Excellence

Delivering high-quality clinical pharmacology submissions is no longer just a scientific challenge – it is an execution challenge. In an environment of rising regulatory expectations and compressed timelines, project managers who deeply understand clinical pharmacology are the ones keeping submission pathways on track, minimizing rework, and enabling faster, more robust filings. This keynote showcases how leading teams integrate structured project management with scientific expertise to transform submission planning and delivery.

• What clear critical paths, milestones, and risk logs reduce late-cycle surprises in clinical pharmacology submissions.

• Practical ways to harmonize cross-functional inputs (clinical, stats, regulatory, safety) and enforce data readiness checkpoints.

• The role of project managers in orchestrating authoring, review, and health authority interactions using digital and AI-enabled tools.

• Why excellence in submission project management is becoming a key differentiator for getting medicines to patients earlier.