Postapproval Changes for Drugs: A Practical Guide
xii
Faustin Ndindayino, PhD
CEO and Managing Director
Afrobridge Pharma Ltd.
Mali
Chapters 19 and 22
Hongbo Pan, MBA
Head of China RA and R&D Site (Shanghai
and Beijing)
CSL Behring
Chapter 17
Hadeer Abdulbasir Sayed
EMEA Regulatory Affairs Lifecycle Manager
Egypt
Chapters 13 and 14
Kathrin Schalper, PhD, RAC-US, RAC-EU,
RAC-CAN, RAC-Devices
Principal Consultant, Regulatory Affairs and
Managing Member
Senita Consulting, LLC
US
Chapter 10
Seema Singh, MSc
Group Leader Regulatory Affairs and CMC
Mitsubishi Tanabe Pharma Corp.
Japan
Chapter 9
Shakti Tripathy, MPharm
Regulatory Affairs
Dr. Reddy’s Laboratories Ltd.
India
Chapter 2
Pallavi Trivedi, MPH, RAC-US
Senior Manager
Viatris
Chapters 3 and 21
Blaine Van Leuven, MS, RAC
Director, Regulatory CMC
Premier Consulting
US
Chapter 6
Julie Watchorn, MSc, RAC-EU
Senior Regulatory Affairs Consultant
Parexel
Ireland
Chapters 11 and 21
Fatima Zaid Abu Zanat, MSc, RPh, RAC-
Drugs, RAC-Devices
Regional Director of Regulatory Affairs and
Scientific Office
Middle East, Turkey, and Africa
Ispen
UAE
Chapter 18
Jing Zhou, MS
Manager, Regulatory CMC
PTC Therapeutics
US
Chapter 15