Fundamentals of Biologicals Regulation

<p>About the authors<br>Foreword<br>Preface<br>How to obtain documents from ICH and US</p><h2>SECTION I: Regulatory process</h2>1 Introduction to the regulatory process for biologicals and to international regulatory convergence<br>2 Discovery and development<br>3 Communications and formal meetings with regulators<br>4 Clinical trial authorization and investigational new drug applications<br>5 Marketing authorization<br>6 Alternative regulatory pathways and special programs<br>7 Variations or changes to an approved application<br>8 Good &ldquo;X&rdquo; Practices<br>9 Audits and regulatory compliance inspections<br>Written assignments exercise<br>Assignment Scenarios<br> <h2>SECTION II: Regulatory science</h2>10 Preclinical safety and toxicology<br>11 Preclinical pharmacology, proof‑of‑principle<br>12 Institutional biosafety committees and regulation of genetically modified organisms<br>13 Risk assessments<br>14 Quality by design and product design, construction, development, manufacture, and process validation<br>15 Lot release, analytics, and analytical validation<br>16 Regulatory aspects of clinical trials<br>17 Pharmacovigilance, safety reporting, and risk minimization<br>18 Clinical trial ethics, human subjects protections, and the informed consent process<br>19 Independent ethics committees and institutional review boards<br> <h2>SECTION III: Specific product types</h2><p>20 Biosimilars<br>21 Cell and gene therapies<br>22 In vitro diagnostics and biotech medical devices<br>23 Combination products<br><br>Glossary<br>Index</p>