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A
Acker, AJ

Annexon Biosciences

Akra, Bassil

Akra Team GmbH

Alexander, Derecka

American Association for the Advancement of Science/USDA

Amiri, Farhad

Parexel International

Apostolaros, Maria

PhRMA

Asally, Razan

Saudi Food and Drug Authority

Axtell, Patrick

FDA

B
Bain, Susan

University of Southern California

Beakes-Read, Ginny

Janssen Pharmaceuticals

Belsky, Kimberly

Planning Committee Chair Convergence 2023

Benton, Kimberly

Dark Horse Consulting Group

Bent, Robyn

FDA

Bhatt, Monika

Siemens Healthineers

Bischoff-Everding, Peter

European Commission, Directorate-General Health and Food safety

Blank, Tony

AtriCure, Inc.

Bly, Sarah

Worldwide Clinical Trials

Borg, John

Malta Medicines Authority

BOS, GERRIT WILLEM

Qservegroup

Bos, Gert

Qserve Group

Bowen, Linda

Seagen Inc.

Bozsik, Balazs

SGS North America Inc.

Brown, Paul

Food and Drug Administration

Brown, Phil

ABHI

Brown, Scott

1WorldSync, Inc.

Bugin, Kevin

FDA

Burde, Stefan

TÜV SÜD America Inc.

Butlen, Florence

European Medicines Agency

C
Caldwell, Brittany

Caldy, Victoria

Cisema

Caños, Daniel

US Food and Drug Administration

Carino, Susan

Integrated Project Management Company, Inc.

Carnielli, Marta

TUV Sud GmbH

Carr, Cameron

Kalypso: A Rockwell Automation Company

Castéras, Vincent

nexialist

Chadwick, David

Independent

Chance, Kamali

KC Biopharmaceutical Consulting

Chang, Janice

TransCelerate BioPharma Inc.

Chan, Jenny

Abbott

Chan, Joseph

Bayer

Chollet, Amélie

CHORGHADE, Veena

PTC Therapeutics, Inc.

Christl, Leah

Amgen

Colburn, Scott

US Food and Drug Administration

Colvin, Heather

Johnson & Johnson MedTech

Coulter, Josh

Pfizer

Croker, Alysha

Health Canada

Cron, Sandra

Organon

Crowley, Jay

USDM Life Sciences

D
Dalton, Allison

The George Washington University

DeGennaro, Torrie

RQM+

Delatte, Marcus

Allucent

Delorme, Corinne

nexialist

DeNiro, Nynne

Acolad Life Sciences

Desai, Mona

Desai RA Consultants, LLC

Dhami, Ritu

Network Partners Group

DiAngelo, Laura

POLITICO's AgencyIQ

Dormeyer, Matthias

Granzer Regulatory Consulting & Services GmbH

Drago, Daniela

NDA Partners

Duarte, Joao

Alexion, AstraZeneca Rare Disease

DuVal, Mark

DuVal & Associates, P.A.

Dyson, Claire

DQS Medizinprodukte UK Ltd

E
EGELEBO, CHRISTOPHER

US Food and Drug Administration

Ekuta, Jethro

Alexion, AstraZeneca Rare Disease

Elmore, Tabitha

Pharming Healthcare, Inc.

Enright, Gareth

National Standards Authority of Ireland

Espinasse, Claire

Evans, Courtney

F
Fink, Matthias

Akra Team Inc.

Franco, Pedro

Merck KGaA

Friend, Danielle

Janssen

Fuh, Kenneth

TÜV SÜD GmbH

G
Gadagkar, Hrishikesh

RQM Plus

Gaffney, Alexander

POLITICO's AgencyIQ

Gamerman, Jamie

FDA

Gerald, Brittany

Moderna

Ghosh, Abhijit

Gianoutsos, James

Rimsys

Gimbel, Jonathan

RQM+

Gingery, Derrick

The Pink Sheet

Giroud, Danielle

MD-CLINICALS SA

Goates, Scott

Abbott

Gomes, Cammilla

Roche

Gooley, Ryan

Sedgwick

Govindaiah, Padma

ArisGlobal

Gowda, Grace

University of Georgia

Goyal, Shefali

Organon

Graham, Heather

Certara

Gravanis, Iordanis

European Medicines Agency

Greidanus, Joy

Celegence

Gupta, Nishchay

Genentech

H
Halliday, Suzanne

BSI

Harrington, Gerry

Haubenreisser, Sabine

European Medicines Agency

Hawkins, Lisa

Network Partners

Heckman, Niedre

Takeda

Helman, Richelle

MEDIcept

Herzog, Kathy

DuVal & Associates, P.A.

Hewitt, James

TÜV SÜD

Hinds, David

BioMarin Pharmaceutical Inc.

Hoekstra -van den Bosch, Sabina

TÜV SÜD Medical Health Services

Hoekstra-van den Bosch, Sabina

TÜV SÜD

Holborow, Richard

BSI

Holzman, Jeff

Item Alignment Inc.

Holzmann, Catherine

GMED Certification Division

Honegger, Thibault

NETRI

Hovestadt, Leo

Elekta

Huemer, Karl-Heinz

khhconsulting

Hughes, Christie

Qserve Group

Hussong, Virginia

FDA Center for Biologics Evaluation and Research

Hutchinson, Thomas

QRE MedTech LLC

I
Inamdar, Sanika

Obsidian Therapuetics

Ingle, Priyanka

Bayer Pharmaceuticals

Islaih, Mohammed

Zimmer Biomet

Iyer, Megha

Thermo Fisher Scientific

J
Jamis, Lina

Synthego Corporation

Jeary, Theresa

BSI Group

Jeiter, Tonia

TÜV SÜD Product Service GmbH

Jennings, Jocelyn

Mycovia Pharmaceuticals, Inc.

Jew, Korinne

Medtronic

Joneckis, Christopher

US FDA

Jump, Michelle

MEDSEC

Jung, Yoon Sik

University of Southern California

K
Kaminski, Erez

Ketryx Corporation

Kanani, Kunal

Annexon Biosciences

Kapasi, Naushad

Clarivate

Kaplan, Kim

ISACA

Kaspar, Ben

MMS Holdings

Katta, jayanth

BSI

Khera, Aman

Worldwide Clinical Trials

Khorshidi, Azam

DEKRA

King, Hamish

Cisema

Klum, Susanne

Dr. Ebeling & Assoc. GmbH

Knight, Yvonne

US Food and Drug Administration

Koduri, Chaitanya

United States Pharmacopeia

Kunkoski, Elizabeth

FDA

Kurdyn, Szymon

DQS Medizinprodukte GmbH

Kyria, Elena

Elemed

L
Laan, Alex

BSI Group The Netherlands B.V.

Langevin, Nicholas

Sumitomo Pharma America, Inc.

Larsson, Kristina

European Medicines Agency

Laslop, Andrea

Austrian Medicines and Medical Devices Agency

Leander, Niels

NNIT

Lee, Jill

Novo Nordisk

Lehoczki, Arpad

GlobalVision

Lejcher, Marielle

Fang Consulting

Liberti, Lawrence

Li, Jingrui

The University of Southern California

Lin, Rita

Agilis by Kymanox

Loh, Evangeline

Emergo by UL

Lozito, Antonella

Moderna

M
Mahapatra, Soumya

Essenvia

Maloney, Rani

Integrated Project Management

Mandaokar, Saumya

USC

Marcal, Anabela

European Medicines Agency

Marchaim, Hagit

HMC-Regulation

Marks, Peter

United States Food and Drug Administration

Martin, Jewell

BioMarin Pharmaceuticals, Inc.

Massoud, Alexandra

Exact Sciences

Mayer-Nicolai, Christine

Merck KGaA, Darmstadt, Germany

McBride, Linda

IAA Consulting LLC

McDole-Russell, Monika

Medtronic Endoscopy

McMaster, Owen

Food and Drug Administration

McMillan, Robin

Abbott

McMoil, Bill

Regulatory Affairs Professionals Society (RAPS)

Mead, Douglass

CP Pathways LLC

Mead, Rachel

BSI Group

Mendelsohn, Jesse

Model N

Messmer, Kirsten

POLITICO’s AgencyIQ

Michel, Sarah

Velvet Chainsaw Consulting

Middleton, Rosanne

Lifescan

Millet, Stephane

Acolad Life Sciences

Mitchell, Renee

Boston Scientific

Moeller, Ludger

MDSS GmbH

Momonoi, Yoko

Takeda Pharmaceuticals

Moon, Linda

BSI Group

Morel, Keith

Qserve Group

Morrison, Nancy

RQM+

Motta, Daniëlle

Qserve Group BV

N
Naccache, Mayss

World Federation of Hemophilia

Naguib, Gabriella

GlobalVision

Naughton, Jennifer

RAPS

Nesbitt, Emily

Ng Ain Kin, Jennifer

Abbott Laboratories

Nichols, Etienne

Greenlight Guru

Nikolova, Antonina

Allucent

Nwokedi, Mary

PhRMA

O
O'Connor, Mallory

Mallinckrodt

Oliver, Erin

Haleon

Osmani, Amin

Cedience Inc.

O'Sullivan, Kathleen

Bayer

P
Palagi, Gregory

Integrated Project Management, Inc.

Pangu, Abhijit

Pharnext

Papadopoulos, Philipp

The FlexPro Group

Patel, Purvi

BSI Group

Patten, Tom

NSAI

Peay, Free

Peay Regulatory Affairs Consulting, LLC

Perkins, Vada

Bayer Pharmaceuticals

Pilgrim, Ken

Emergo by UL

Plueschke, Kelly

European Medicines Agency (EMA)

Pokrop, Frank

QuidelOrtho

Pool, Larry

Cook Incorporated

Pothet, Caroline

European Medicines Agency

Potter, Andrew

US FDA

Prawdzik, Sally

Health Canada

Prevoo, Judith

BSI

Pribluda, Victor

United States Pharmacopeia

Prieto Yerro, Maria

Spanish Agency for Medicines and Medical Devices

Pritchard, Lisa

DuVal & Associates, P.A.

R
Racic, Amra

Veeva Systems

Racolta, Adriana

Seagen, Inc

Ray, Amrit

Principled Impact

Richardson, Peter

European Medicines Agency (EMA)

Robinson, Jamie

Genentech, Inc.

Robinson, Kelly

Health Canada

Rocha, Luis

Allucent

Rodriguez, Gail

US Food and Drug Administration

Roy, Dhritikshama

Essenvia

S
Salditt, Diana

Salditt Regulatory Consulting LLC

Salerno, Mary Jo

US Food and Drug Administration

San Jose, Cassandra

Biogen

Sandhu, Punam

Jazz Pharmaceuticals

Saner, Gary

LexisNexis Reed Tech

Savoie, Brian

RAPS

Schwartz, Suzanne

US FDA

Scogland, Brian

Veeva MedTech

Sharma, Khushboo

Accumulus Synergy

Shiryaev, Alexey

DNV Product Assurance AS

Shurig, Darwin

Shurig Solutions, Inc

Sietsema, William

Lisata Therapeutics

Singh, Guriqbal

Regweb Consulting Services Inc.

Singh, Kamana

APS Pharma Solutions, LLC

Sirois, Jay

Consumer Health Products Association

Siroka, Brian

MEDIcept Inc.

Smith, Alex

Hogan Lovells LLP

Sommerer, Sophie

Health Canada

Soo, Chin-Wei

Genentech and Roche

Speicher, Susan

UpToDate, Inc.

Standish, Trevor

Certara

Stange, Andreas

TUV SUD

Stefko, Melissa

The FlexPro Group

Stewart, Susan

Candel Therapeutics

Stowell, Yoshiko

Neuron23, Inc.

Suleman, Dinar

Lifescan

Summers, Lindsey

Day One Biopharmaceuticals

T
Tan, Lucy

Abbott

Tarver, Michelle

U.S. Food and Drug Administration/ CDRH

Terrell, Danielle

Food and Drug Administration

Thakker, Vishal

BSI Group

Torfin, Jacqueline

Quality and Regulatory Expert Partners, LLC

Torr, Marcus

Purdie Pascoe

Torset-Bonfillou, Florianne

GMED North America

Trautman, Kimberly

MEDIcept

Triest, Myriam

CMC-RX Consulting

V
van Grol-Lawlor, Olga

Boston Scientific

VanderBand, Hillary

Abbott Laboratories

Vandivort, Tyler

Amplicore Inc

Vaughn, Janet

Teva Pharmaceuticals

Vollebregt, Erik

Axon Lawyers

W
Walther, Elisabeth

US Food and Drug Administration

Wang, Junyang

EMD Serono

Ward, Diane

Qserve Group US

Wardle, Paul

Beacon Associates, LLC

Waterland, Robert

Certara Drug Development Solutions

Welch, Chelsea

ARUP Laboratories

Whalley, Chris

Seattle Genetics

Whitehead, Alfred

Klick Consulting

Wiersma, Anja

mi-CE consultancy

Wierzba, Mike

GSK

Williams, Cham

IQVIA

Wiseman, Bridget

IQVIA

Wong, Amanda

Haleon Canada

Woodcock, Janet

United States Food and Drug Administration

Wright, Waylon

Celegence

Wu, Michelle

NyquistAI

Y
Ye, Helen

Accestra Consulting

Z
Zaibel, Rivka

ADRES, Advanced Regulatory Services Israel Ltd.

Zdrojewski, Immo

Moderna

Zhu, Jocelyn

BradyKnows Medical Group

Ziolkowski, Olivia

Takeda Pharmaceuticals

Ziskoven, Christoph

TÜV Rheinland LGA Products GmbH