Program Scope

This training program covers the entire drug development and approval process from discovery through post-approval lifecycle management. You will learn the complete drug approval pathway, then dive deep into each component of the New Drug Application (NDA) organized into the five CTD modules.

Case studies are integrated throughout for oral solid (tablets), parenteral (injectable vials), and oral solution (liquid) dosage forms.

Program Objectives

Upon completion of this training program, participants will be able to:

• Describe the complete drug approval pathway from discovery to post-approval.
• Submit a complete NDA organized into the five CTD modules.
• Draft and organize all five modules of the CTD.
• Prepare CMC sections for different dosage forms.
• Compile nonclinical and clinical reports to support safety and efficacy.
• Manage post-approval changes and labeling requirements.

Target Audience

• Regulatory Affairs Specialists and Associates
• Clinical Research Associates
• Medical Writers
• CMC Associates and Managers
• Nonclinical Scientists
• Quality Assurance Professionals
• Project Managers
• Compliance Officers
• Legal and Patent Professionals

Certifications

Learners who successfully complete the program will receive a dated, traceable certificate that provides verifiable proof of their achievement for professional records.