Regulatory Submissions: From IND to Market Authorization

This course provides a comprehensive overview of the regulatory pathways and submission processes for drugs and biologics from early development through market approval.

Students will learn to prepare and submit Investigational New Drug (IND) applications, New Drug Applications (NDA), Biologics License Applications (BLA), and their global equivalents.

The course covers the structure, content, and technical requirements of regulatory submissions and the roles of key health authorities, including the FDA and EMA.

Emphasis is placed on strategic planning, electronic submission standards (eCTD), and post-approval obligations.