v
Chapter 10
Jan-Paul van Loon, MSc, PhD
Senior QA/RA Engineer
Demcon
Netherlands
Gert Bos, MSc, PhD, FRAPS
Chief Scientific Officer, Executive
Director, and Partner
Qserve Group
Netherlands
Chapter 11
Anu Gaur, PhD, MBA, MSRA,
RAC
Faculty, Regulatory Affairs
Graduate Program
College of Professional Studies (CPS)
Northeastern University
US
Chapter 12
Kurt M. Stahl
Senior Toxicologist
MacroGenics, Inc.
US
Jennifer G. Brown, PhD, RAC
Director of Toxicology
MacroGenics, Inc.
US
Chapter 13
Andrea Armando, RAC
Corporate Director, Regulatory
Affairs
DiaSorin
Italy
Chapter 14
Joscelyn Bowersock, MSc
Therapeutics Implementation Lead
L7 Informatics
US
Richard Vincins, CQP, MCQL,
CBA, CQA, RAC
Vice President Global Regulatory
Affairs
Oriel STAT A MATRIX
UK
Chapter 15
Bocar Guisse, MSc
Manager, Regulatory Affairs, CMC
Canada
Fraidianie Sévigné
Director, Regulatory Affairs, CMC
Canada
Chapter 16
Debra Goetchius
Associate Director, Global Labeling
Implementation
Janssen Research and Development,
LLC
US
Chapter 17
Stephen Antonelli, PhD
Senior Director, Regulatory CMC
Cogent Biosciences, Inc.
US
Michael Craig
Principal Consultant
Parexel International
Ireland
Chapter 18
Joanne S. Hawana, MS, JD
Member
Mintz, Levin, Cohn, Ferris,
Glovsky, and Popeo, PC
US
Bethany J. Hills, MPH, JD
Partner and Co-Chair, FDA and
Life Science Compliance Practice
Morrison and Foerster LLP
US
Benjamin M. Zegarelli, MS, JD
Of Counsel
Mintz, Levin, Cohn, Ferris,
Glovsky, and Popeo, PC
US
Chapter 19
Anu Gaur, PhD, MBA, MSRA,
RAC
Faculty, Regulatory Affairs
Graduate Program
College of Professional Studies
(CPS)
Northeastern University
US
Bettina Merz-Nideroest, MPharm
Hospital Pharmacist
Central Pharmacy at DRK
Kliniken Berlin
Germany
Andrea Zobel, PhD
Senior Director, Personalized
Supply Chain
AmerisourceBergen World Courier
Germany