Pharmacokinetics and Pharmacodynamics for Beginners and Professionals

Understanding the scientific principles behind how drugs move through the body and exert their effects is essential for ensuring product quality, regulatory compliance, and patient safety. This course is designed to help pharmaceutical and healthcare professionals navigate the core principles of pharmacokinetics (PK) and pharmacodynamics (PD), highlighting their role in drug development, regulatory review, and safety monitoring.

Developed by experts in regulatory affairs, pharmacovigilance, and clinical science, this self-paced course translates complex PK/PD concepts into actionable knowledge using real-world examples, case studies, and cross-functional scenarios.

Upon successful completion, you will receive a validated certificate accredited with CPD/CEU credits and recognized by auditors.

✅ Who should enroll?
This course is designed for professionals involved in clinical trials, regulatory submissions, safety monitoring, or quality assurance, including:

• Regulatory Affairs specialists
• Pharmacovigilance and drug safety professionals
• Quality Assurance and CMC teams
• Clinical research and medical affairs personnel
• R&D scientists and formulation developers
• Professionals preparing regulatory submissions or reviewing PK/PD data

🎯 What you’ll learn?

• Grasp the fundamental principles of pharmacokinetics (PK) and pharmacodynamics (PD)
• Distinguish between how the body affects a drug (PK) and how the drug affects the body (PD)
• Understand the role of PK/PD in drug development, dose optimization, and regulatory approval
• Learn how PK/PD data is presented and reviewed in regulatory submissions
• Apply PK/PD insights in pharmacovigilance, risk evaluation, and safety monitoring

Curriculum:

Lesson 1: Introduction to Pharmacokinetics (PK) and Pharmacodynamics (PD)

Lesson 2: Fundamentals of Pharmacokinetics (PK)

• The four stages of ADME: Absorption, Distribution, Metabolism, Elimination
• Key PK parameters and their regulatory relevance
• Interpreting PK data in regulatory documents

Lesson 3: Fundamentals of Pharmacodynamics (PD)

• What is PD?
• Mechanisms of drug action and therapeutic effect

Lesson 4: PK/PD Integration

• How PK and PD work together
• Why PK/PD integration is important
• Examples of PK/PD integration in practice

Lesson 5: PK/PD in Regulatory Submissions

• FDA and EMA expectations for PK/PD data
• Typical PK/PD data included in submissions
• CTD structure (NDA)

Lesson 6: PK/PD in Safety and Pharmacovigilance

• PK/PD in safety monitoring
• Dose–response vs. exposure–response
• Identifying high-risk populations and applying REMS
• Case example: Zyprexa Relprevv REMS

Lesson 7: Practical Applications Across Roles

• Who PK/PD belongs to across functions
• Interpreting data as a cross-functional team (mini case study)

Conclusion

Assessment