IND/CTA Preparation, Submission and Agency Interfacing

This course provides a strong foundation in regulatory affairs during early-stage drug development, with a focus on preparing and submitting Investigational New Drug (IND) and Clinical Trial Application (CTA) filings.

Students will learn how regulatory professionals facilitate communication between cross-functional teams and regulatory agencies such as the U.S.

Food and Drug Administration and international health authorities throughout the clinical trial initiation process.

The curriculum covers IND- and CTA-enabling studies, submission components, regulatory compliance requirements, submission strategy, and processes for supporting accurate and successful regulatory review.

Learners will gain practical skills in regulatory submission planning, agency communication, project management coordination, regulatory documentation, and responding to regulatory inquiries to support the initiation of clinical trials.

This course prepares students for careers in regulatory affairs, clinical development, regulatory submissions, and early-stage drug development within the pharmaceutical and biotechnology industries.