SECTION I REGULATORY PROCESS 1. Introduction to the Regulatory Process for Biologicals 2. International Regulatory Convergence 3. Quality by Design (QbD) Approach to Discovery and Development 4. Communications and Formal Meetings With Regulators: Focusing on the Process Before Clinical Trial 5. Clinical Trial Authorization and investigational New Drug Applications 6. Marketing Authorization 7. Alternative Regulatory Pathways and Special Programs 8.

Variations or Changes to an Approved Application 9. Good "X" Practices 10. Audits and Regulatory Compliance inspections SECTION II REGULATORY SCIENCE PART I PRECLINICAL 11. Preclinical Safety and Toxicology 12. Preclinical Pharmacology , Proof-of-Principle 13. Institutional Biosafety Committees and Regulation of Genetically Modified Organisms 14. Risk Assessments PART II PRODUCT 15. Product Construction, Manufacture, and Process Validation 16.

Analytical Method Development and Validation Leading to Control Strategy and Lot Release PART Ill CLINICAL 17. Regulatory Aspects of Clinical Trials 18. Pharmacovigilance and RiskMAPs 19. Clinical Trial Ethics, Human Subjects Protections, and the Informed Consent process 20. Independent Ethics Committees and Institutional Review Boards SECTION Ill PRODUCT-SPECIFIC REGULATORY PROCESSES 21. Biosimilars 22. In Vitro Diagnostics and Biotech Medical Devices 23. Combination Products 24.

Regulatory Policy and Public Health Policy.