Drug Development course Syllabus

Overview: This course provides a comprehensive introduction to the drug development process, guiding learners through each stage from initial discovery to post-market monitoring. Designed for beginners in health sciences, it spans approximately 12 weeks of part-time study with a total time commitment of 40–50 hours. Modules blend foundational science, regulatory principles, and real-world applications to deliver an industry-relevant understanding of how new medicines are brought to patients.

Module 1: Introduction to Drug Discovery

Estimated time: 10 hours

• Identification of drug targets in disease pathways
• Molecular screening techniques for potential compounds
• Selection and optimization of lead compounds
• Overview of early-stage laboratory research in drug development

Module 2: Preclinical Development

Estimated time: 12 hours

• Principles of toxicology and safety assessment
• Basics of pharmacokinetics (how the body affects the drug)
• Basics of pharmacodynamics (how the drug affects the body)
• Design and evaluation of preclinical studies
• Regulatory requirements for transitioning to clinical trials

Module 3: Clinical Trials and Regulatory Approval

Estimated time: 14 hours

• Structure and objectives of Phase I, II, and III clinical trials
• Data collection, monitoring, and analysis in clinical studies
• Role of regulatory agencies in drug review and approval
• Understanding approval standards and submission pathways

Module 4: Post-Market Surveillance and Pharmacovigilance

Estimated time: 8 hours

• Introduction to Phase IV trials and long-term safety monitoring
• Pharmacovigilance systems and adverse event reporting
• Risk assessment and management after drug approval

Module 5: Commercialization and Manufacturing

Estimated time: 10 hours

• Drug manufacturing processes and quality control standards
• Marketing authorization and regulatory compliance
• Strategies for market launch and access

Module 6: Final Project

Estimated time: 6 hours

• Synthesize knowledge across the drug development pipeline
• Develop a case study outlining a drug’s journey from discovery to market
• Include key milestones, regulatory interactions, and safety considerations

Prerequisites

• Basic understanding of biology or chemistry helpful
• No prior industry experience required
• Familiarity with scientific terminology recommended

What You'll Be Able to Do After

• Describe the complete lifecycle of drug development
• Explain the purpose and design of clinical trial phases
• Understand regulatory processes and compliance requirements
• Identify safety evaluation and risk assessment practices
• Apply knowledge to careers in pharmaceuticals, biotech, or clinical research