x Regulatory Affairs Professionals Society (RAPS)
Section IV: Clinical Trials
Chapter 15: Conducting Clinical Trials: Drug Application Types, Data Requirements and Obtaining Marketing Approval...................... 167
Sharry Arora, MPharm, RAC-Drugs Viktória Pásztor, MS Bayan A. Arar, BPharm, RPh
Chapter 16: Phases of Development (1,2,3,4)............................................................................................................................................... 177
Rowena Cook, MS, RAC-Global Amanda McEwen, MRes Shuli Cui, MS, RAC-US Stefanie Fasshauer, MBA
Chapter 17: Enhancing Diversity in Clinical Trials. .....................................................................................................................................215
Monique Carter, MS, RAC, FRAPS Zaida Recinos-Vasquez, MSPS, MSRAQA Leonor Pessanha Saldanha, PhD, MSc
Chapter 18: Health Authority Interactions................................................................................................................................................... 231
Chauneen Leah Wood, MS, RAC-US Azzurra Ravizza, MS
Chapter 19: Pediatrics. ..................................................................................................................................................................................255
Linda McBride, RPh, RAC-US
Chapter 20: Regional-Specific Studies.......................................................................................................................................................... 271
Mantej (Nimi) Chhina, PhD, JD, MSc Marjorie Zettler, PhD, MPH
Section V: Marketing Authorization
Chapter 21: Framework for Benefit-Risk Assessment. .................................................................................................................................283
Cristina Damatarca, MD, PgDip
Chapter 22: eCTD and Digital Applications................................................................................................................................................ 295
Amrita Ghosh, RAC-US Danini Marin, MSc Katelyn Mulligan, MS
Chapter 23: Expedited Approval Pathways................................................................................................................................................... 305
Yingying Liu, MS Kathrin Schalper, PhD, RAC-CAN, RAC-Devices, RAC-EU, RAC-US Ching Li, PhD Christinne V. Villanueva, MS Hongbo Pan, MBA
Grzegorz Podrygajlo, PhD
Chapter 24: Dossier Requirements................................................................................................................................................................ 353
Jesshanie Tabaniag, RPh Kholoud Mamdouh Abdelfattah, MSc Stefanie Fasshauer, MBA Danini Marin, MSc and Prashant Bhatia, MSc
Section VI: Postmarketing Authorization
Chapter 25: Postauthorization Commitments.............................................................................................................................................. 395
Linda McBride, RPh, RAC-US
Chapter 26: Transfers and Renewals. ............................................................................................................................................................405
Linda McBride, RPh, RAC-US
Chapter 27: Product Extensions, Variations, and Supplements. ....................................................................................................................425
Linda McBride, RPh, RAC-US
Chapter 28: Compliance. ..............................................................................................................................................................................447
Siegfried Schmitt, PhD Barbara Rusin, MS Anne Marie Woodland, MS, RAC-EU, RAC-US
Chapter 29: Recalls. ......................................................................................................................................................................................463
Siegfried Schmitt, PhD
Section IV: Clinical Trials
Chapter 15: Conducting Clinical Trials: Drug Application Types, Data Requirements and Obtaining Marketing Approval...................... 167
Sharry Arora, MPharm, RAC-Drugs Viktória Pásztor, MS Bayan A. Arar, BPharm, RPh
Chapter 16: Phases of Development (1,2,3,4)............................................................................................................................................... 177
Rowena Cook, MS, RAC-Global Amanda McEwen, MRes Shuli Cui, MS, RAC-US Stefanie Fasshauer, MBA
Chapter 17: Enhancing Diversity in Clinical Trials. .....................................................................................................................................215
Monique Carter, MS, RAC, FRAPS Zaida Recinos-Vasquez, MSPS, MSRAQA Leonor Pessanha Saldanha, PhD, MSc
Chapter 18: Health Authority Interactions................................................................................................................................................... 231
Chauneen Leah Wood, MS, RAC-US Azzurra Ravizza, MS
Chapter 19: Pediatrics. ..................................................................................................................................................................................255
Linda McBride, RPh, RAC-US
Chapter 20: Regional-Specific Studies.......................................................................................................................................................... 271
Mantej (Nimi) Chhina, PhD, JD, MSc Marjorie Zettler, PhD, MPH
Section V: Marketing Authorization
Chapter 21: Framework for Benefit-Risk Assessment. .................................................................................................................................283
Cristina Damatarca, MD, PgDip
Chapter 22: eCTD and Digital Applications................................................................................................................................................ 295
Amrita Ghosh, RAC-US Danini Marin, MSc Katelyn Mulligan, MS
Chapter 23: Expedited Approval Pathways................................................................................................................................................... 305
Yingying Liu, MS Kathrin Schalper, PhD, RAC-CAN, RAC-Devices, RAC-EU, RAC-US Ching Li, PhD Christinne V. Villanueva, MS Hongbo Pan, MBA
Grzegorz Podrygajlo, PhD
Chapter 24: Dossier Requirements................................................................................................................................................................ 353
Jesshanie Tabaniag, RPh Kholoud Mamdouh Abdelfattah, MSc Stefanie Fasshauer, MBA Danini Marin, MSc and Prashant Bhatia, MSc
Section VI: Postmarketing Authorization
Chapter 25: Postauthorization Commitments.............................................................................................................................................. 395
Linda McBride, RPh, RAC-US
Chapter 26: Transfers and Renewals. ............................................................................................................................................................405
Linda McBride, RPh, RAC-US
Chapter 27: Product Extensions, Variations, and Supplements. ....................................................................................................................425
Linda McBride, RPh, RAC-US
Chapter 28: Compliance. ..............................................................................................................................................................................447
Siegfried Schmitt, PhD Barbara Rusin, MS Anne Marie Woodland, MS, RAC-EU, RAC-US
Chapter 29: Recalls. ......................................................................................................................................................................................463
Siegfried Schmitt, PhD