Fundamentals of Pharmaceutical and Biologic Regulations: A Global Perspective
vi Regulatory Affairs Professionals Society
Charles E. Lambert, PhD, DABT, ERT
Principal
Intrinsik
Yingying Liu, MSc
Associate Director
CSL
Danini Y. Marin, MSc
Regulatory Affairs Consultant
Jewell D. Martin, MBA, MA, PMP,
RAC-US
Director of US R&D and Regulatory
Policy
BioMarin Pharmaceutical Inc.
Karin McIntosh, MPharm, RAC-Drugs
Head of Regulatory Affairs
Orca Bio
Ben McLaughlin, MSE
Principal Consultant
Amylaza Consulting
Marcello Milano, MSc
Director, R&D and Regulatory Policy
BioMarin UK Ltd
Katelyn Jean Mulligan, EMBA, MS
Associate Director, Regulatory Affairs
Nefro Avillion Clinical Development
Kingman Ng, PhD
Executive Director
Eli Lilly and Company
Cathleen A. O’Connell, PhD, MS, RPh
Retired Regulatory Executive and
Associate Professor
Komalkumar Patel, MS
Associate Director, Pharmaceutical
Development
Experic LLC
Ajay Babu Pazhayattil, DBA, MPharm,
CPGP
President
cGMP World
Kalaiselvan Ponnusamy, MVSc, DIBTP,
DICVP, DABT
Assistant Director
Syngene International Limited
Zaida Recinos-Vasquez, MS, MS
Senior Manager, Regulatory Global
CMC Strategist
Pfizer Inc.
Brian M. Roche, PhD, DSP, DABT
General Manager
Charles River Laboratories
Darlene (Dar) Rosario, MBA, BS,
RAC-US
Principal Consultant, Regulatory Affairs
CMC and Combination Products
Velocity Consulting
Barbara A. Rusin, MS
Owner/ Independent GxP Consultant
Phoenix Select Regulatory Consulting,
LLC
Leonor Saldanha, PhD, MS
Regulatory Affairs Manager
Thermofisher Scientific
Brante P. Sampey, PhD, DABT
Director, Toxicology
Intrinsik
Jennifer K. Saxe, PhD, MBA
Global Lead, Environmental
Sustainability and Safety
Kenvue
Kathrin Schalper, PhD, RAC-Devices,
RAC-US, RAC-CAN, RAC-EU
Principal Consultant, Regulatory Affairs
Senita Consulting, LLC
Neel Kamal Sharma, PhD, MS
Sr. Toxicologist
MacroGenics, Inc.
Salah Shawky, DrBA
Biologicals registration unit manager
Egyptian Drug Authority
Beat U. Steffen, MSc, MBA,
RAC-Devices, FRAPS
Founder &Principal Consultant
confinis ag
Consuela Stewart
Owner and Principal Consultant
Kezoshi Regulatory Consulting
Ramesh Subramani, DVM, DABT,
ERT, DSP, RAC-US
Preclinical Consultant
Jesshanie Tabaniag
Regulatory Program Management
Professional- International
Roche Products Limited
Sagar Thakali, PhD, IBERA
Environmental Steward
Kenvue
Pallavi Trivedi, MPH
Associate Director, Regulatory Affairs
Novo Nordisk A/S
Stephanie Turri Lockman, MS
Associate Director, Global Labeling
Product Leader
Johnson &Johnson
Rudradutt Singh Vaghela, PhD,
RAC-Drugs
Senior Regulatory Affairs Professional
Novo Nordisk A/S
Tyler Vandivort, PhD, DABT,
RAC-Drugs
Associate Director, Regulatory Affairs
Lead
UCB Pharma
Nikolaos Zacharias, MS
Regulatory Affairs Team Leader
Yuwei Zhang, MD, PhD, MPH, MBA
Director, Innovation &Digital Health
Northern Medical Center
Section Editors
This edition builds on the work of the
section editors, whose contributions in the
prior edition are deeply appreciated:
Kimberly Belsky, MS, FRAPS Devanshi
Maharaja, MSc, MTech Daniel G.
Mannix, PhD, FRAPS Flora Siami,
MPH Kip Vought.
vi Regulatory Affairs Professionals Society
Charles E. Lambert, PhD, DABT, ERT
Principal
Intrinsik
Yingying Liu, MSc
Associate Director
CSL
Danini Y. Marin, MSc
Regulatory Affairs Consultant
Jewell D. Martin, MBA, MA, PMP,
RAC-US
Director of US R&D and Regulatory
Policy
BioMarin Pharmaceutical Inc.
Karin McIntosh, MPharm, RAC-Drugs
Head of Regulatory Affairs
Orca Bio
Ben McLaughlin, MSE
Principal Consultant
Amylaza Consulting
Marcello Milano, MSc
Director, R&D and Regulatory Policy
BioMarin UK Ltd
Katelyn Jean Mulligan, EMBA, MS
Associate Director, Regulatory Affairs
Nefro Avillion Clinical Development
Kingman Ng, PhD
Executive Director
Eli Lilly and Company
Cathleen A. O’Connell, PhD, MS, RPh
Retired Regulatory Executive and
Associate Professor
Komalkumar Patel, MS
Associate Director, Pharmaceutical
Development
Experic LLC
Ajay Babu Pazhayattil, DBA, MPharm,
CPGP
President
cGMP World
Kalaiselvan Ponnusamy, MVSc, DIBTP,
DICVP, DABT
Assistant Director
Syngene International Limited
Zaida Recinos-Vasquez, MS, MS
Senior Manager, Regulatory Global
CMC Strategist
Pfizer Inc.
Brian M. Roche, PhD, DSP, DABT
General Manager
Charles River Laboratories
Darlene (Dar) Rosario, MBA, BS,
RAC-US
Principal Consultant, Regulatory Affairs
CMC and Combination Products
Velocity Consulting
Barbara A. Rusin, MS
Owner/ Independent GxP Consultant
Phoenix Select Regulatory Consulting,
LLC
Leonor Saldanha, PhD, MS
Regulatory Affairs Manager
Thermofisher Scientific
Brante P. Sampey, PhD, DABT
Director, Toxicology
Intrinsik
Jennifer K. Saxe, PhD, MBA
Global Lead, Environmental
Sustainability and Safety
Kenvue
Kathrin Schalper, PhD, RAC-Devices,
RAC-US, RAC-CAN, RAC-EU
Principal Consultant, Regulatory Affairs
Senita Consulting, LLC
Neel Kamal Sharma, PhD, MS
Sr. Toxicologist
MacroGenics, Inc.
Salah Shawky, DrBA
Biologicals registration unit manager
Egyptian Drug Authority
Beat U. Steffen, MSc, MBA,
RAC-Devices, FRAPS
Founder &Principal Consultant
confinis ag
Consuela Stewart
Owner and Principal Consultant
Kezoshi Regulatory Consulting
Ramesh Subramani, DVM, DABT,
ERT, DSP, RAC-US
Preclinical Consultant
Jesshanie Tabaniag
Regulatory Program Management
Professional- International
Roche Products Limited
Sagar Thakali, PhD, IBERA
Environmental Steward
Kenvue
Pallavi Trivedi, MPH
Associate Director, Regulatory Affairs
Novo Nordisk A/S
Stephanie Turri Lockman, MS
Associate Director, Global Labeling
Product Leader
Johnson &Johnson
Rudradutt Singh Vaghela, PhD,
RAC-Drugs
Senior Regulatory Affairs Professional
Novo Nordisk A/S
Tyler Vandivort, PhD, DABT,
RAC-Drugs
Associate Director, Regulatory Affairs
Lead
UCB Pharma
Nikolaos Zacharias, MS
Regulatory Affairs Team Leader
Yuwei Zhang, MD, PhD, MPH, MBA
Director, Innovation &Digital Health
Northern Medical Center
Section Editors
This edition builds on the work of the
section editors, whose contributions in the
prior edition are deeply appreciated:
Kimberly Belsky, MS, FRAPS Devanshi
Maharaja, MSc, MTech Daniel G.
Mannix, PhD, FRAPS Flora Siami,
MPH Kip Vought.