v Regulatory Writing: An Overview
Author Acknowledgments
The Regulatory Affairs Professionals Society (RAPS) would like to express appreciation to the following subject
matter experts who shared their experience and knowledge and volunteered their time by contributing to this
book. RAPS also would like to recognize the work of the first edition authors who laid the groundwork for this
second edition.
Kayla Ambroziak, PharmD
Medical Writer
Evidera
US
Mariam Aslam
Independent Consultant
UK
Danny A. Benau, MSOD, PhD
Director, Biomedical Writing
Programs
Misher College of Arts and
Sciences
University of the Sciences in
Philadelphia
US
Gert Bos, MSc, PhD, FRAPS
Executive Director and Partner
Qserve Consultancy BV
Netherlands
Jenny Boyar, PhD
Medical Writer
Medtronic
US
Michelle Carey, PhD
Principal Medical Writer,
FSP 360
Syneos Health
US
Steve Carr
Director, Medical Writing
Janssen Research and
Development
US
Jenny Chen, MD, PhD, RAC
Senior Medical Director, Clinical
Development
Genmab Inc.
US
Evelyn De La Vega Stewart,
MSc, RAC
President
EDS Regulatory Consulting Inc.
US
Brooke Diorio
Associate Director, Clinical
Project Scientist
Janssen Pharmaceutical Co.
US
John M. Ellison, MS
Manager, Regulatory Medical
Writing
Janssen Research and
Development, LLC
US
Helle-Mai Gawrylewski
Principal
Hawkwood Consulting LLC
US
Eileen M. Girten, MS
Adjunct Assistant Professor,
Biomedical Writing
University of the Sciences
US
Jennifer Grodberg, PhD, RAC
Regulatory Affairs Consultant
Jennifer Grodberg Regulatory
Consulting
US
Nathalie Innocent, MS, RAC
Senior Manager Regulatory
Affairs
Pfizer
US
Jocelyn Jennings, MS, RAC
Senior Director, Regulatory
Affairs and Quality Assurance
Mycovia Pharmaceuticals, Inc.
US
Deborah Leonard, RN, MS
Director of Medical Writing
Kyowa Kirin Pharmaceutical
Development, Inc.
US
Author Acknowledgments
The Regulatory Affairs Professionals Society (RAPS) would like to express appreciation to the following subject
matter experts who shared their experience and knowledge and volunteered their time by contributing to this
book. RAPS also would like to recognize the work of the first edition authors who laid the groundwork for this
second edition.
Kayla Ambroziak, PharmD
Medical Writer
Evidera
US
Mariam Aslam
Independent Consultant
UK
Danny A. Benau, MSOD, PhD
Director, Biomedical Writing
Programs
Misher College of Arts and
Sciences
University of the Sciences in
Philadelphia
US
Gert Bos, MSc, PhD, FRAPS
Executive Director and Partner
Qserve Consultancy BV
Netherlands
Jenny Boyar, PhD
Medical Writer
Medtronic
US
Michelle Carey, PhD
Principal Medical Writer,
FSP 360
Syneos Health
US
Steve Carr
Director, Medical Writing
Janssen Research and
Development
US
Jenny Chen, MD, PhD, RAC
Senior Medical Director, Clinical
Development
Genmab Inc.
US
Evelyn De La Vega Stewart,
MSc, RAC
President
EDS Regulatory Consulting Inc.
US
Brooke Diorio
Associate Director, Clinical
Project Scientist
Janssen Pharmaceutical Co.
US
John M. Ellison, MS
Manager, Regulatory Medical
Writing
Janssen Research and
Development, LLC
US
Helle-Mai Gawrylewski
Principal
Hawkwood Consulting LLC
US
Eileen M. Girten, MS
Adjunct Assistant Professor,
Biomedical Writing
University of the Sciences
US
Jennifer Grodberg, PhD, RAC
Regulatory Affairs Consultant
Jennifer Grodberg Regulatory
Consulting
US
Nathalie Innocent, MS, RAC
Senior Manager Regulatory
Affairs
Pfizer
US
Jocelyn Jennings, MS, RAC
Senior Director, Regulatory
Affairs and Quality Assurance
Mycovia Pharmaceuticals, Inc.
US
Deborah Leonard, RN, MS
Director of Medical Writing
Kyowa Kirin Pharmaceutical
Development, Inc.
US