This one-day CME on "Roadmap to Phase 1 Clinical Trials" will cover Human Equivalent Dose (HED) calculation, Phase 1 clinical trials from planning to execution, Bioavailability/Bioequivalence (BA/BE) studies from planning to interpretation, regulation of Phase 1 clinical trials in India, dose extrapolation for Phase 1 clinical trials, and decision-making for First-in-Human (FIH) studies. The program also includes interaction with experts from Contract Research Organisations (CROs), the pharmaceutical industry, and academia possessing vast practical experience in FIH studies, practical discussion on PK–PD calculations and biostatistical interpretation of FIH study data, and an overview of job opportunities in CROs and the pharmaceutical industry related to FIH studies.