Fundamentals of Biologicals Regulation

Dr. Sheets is currently a board member and Executive Committee Member (Vice President for Human Biologicals) of the International Alliance of Biologicals Standardization. She is former Vaccine Scientific and Regulatory Specialist at the National Institute of Allergy and Infectious Diseases. Dr. Sheets served 9 years as a Scientific Reviewer in the Viral Vaccines branch of the Division of Vaccines and Related Products Applications at the Center for Biologics Evaluation and Research at the FDA. From 2006-2014, served as Co-Chair of the World Health Organization’s Study Group on Cell Substrates and as Chair of the Adventitious Agents Sub-committee.

Section I: Regulatory Process1. Introduction2. Discovery and Development of Biologicals3. International Harmonization4. Pre-IND Profess, Guidance from Regulators in Advance of a Clinical Trials Application5. Clinical Trials Approvals and Investigational New Drug Applications6. Marketing Authorization Processes7. Special Regulatory Programs8. Post-Marketing Changes to an Approved Application or Variations9. Compliance and Inspections10. Good "X" Practices

Section II: Regulatory Science11. Preclinical Safety and Toxicology12. Preclinical Proof-of-Concept and Pharmacology, Animal Use Ethics13. Genetically Modified Organisms and Institutional Biosafety Committees14. Risk Assessments15. Chemistry, Manufacturing, and Controls Information (CMC) and Process Validation16. Analytics, Analytical Validation, Lot Release, and National Control Laboratories17. Regulatory Aspects of Clinical Trials18. Ethics of Clinical Trials and the Informed Consent Process19. Institutional Review Board Processes (Ethics Committees)20. Biosimilars21. In Vitro Diagnostics22. Regulatory Policy and Public Health Policy