Agenda at a Glance

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Pre-Conference Workshop

Monday, May 24, 2021

All Times in Eastern Standard Time

10:00 am EST

Lisa Mulcahy
Principal Consultant
Mulcahy Consulting, LLC

2:00 pm EST

Main Conference Day One

Tuesday, May 25, 2021

10:45 am EST

Marion Mays
Vice President, Expert Services and Consulting Solutions
Phlexglobal

11:00 am EST

Keynote Panel

Ne’Dra Bell
TMF Support Analyst
LMK Clinical Research Consulting
Jeanmarie Mathieu
TMF Project Manager
LMK Clinical Research Consulting
David Gaines
TMF Support Analyst
LMK Clinical Research Consulting

11:30 am EST

Priya Chaturvedi
VP, Clinical Quality Assurance
Eisai

12:00 pm EST

12:30 pm EST

Wendy Trimboli
Sr. Director, Clinical Operations Process, Systems & Inspection Readiness
ACADIA Pharmaceuticals Inc.

1:00 pm EST

Gabriela Gottlieb
Clinical Quality Assurance Manager
Terumo Medical Corporation

1:30 pm EST

Karen Roy
Chief Strategy Officer
Phlexglobal
Sarah Tucker
Senior Vice President Customer Management
Phlexglobal

2:00 pm EST

2:30 pm EST

Barbara Novak
Associate Director, Systems & Process Management, Clinical Operations
Kyowa Kirin Pharmaceuticals

3:00 pm EST

Dawn Niccum
Sr. Director, QA and Compliance
Inseption Group

3:30 pm EST

Panel

Angela Hudson Davis
Director, Inspection Management
Regeneron
Rebecca Clancy
Director of Quality Assurance
Neurelis

4:00 pm EST

Main Conference Day Two

Wednesday, May 26, 2021

10:45 am EST

Marion Mays
Vice President, Expert Services and Consulting Solutions
Phlexglobal

11:00 am EST

Sasha El Castra
CEO/CFO/Chair
CrO Biosciences

11:30 am EST

Soraya Nossoughi
TMF Lead
Regeneron Pharmaceuticals

12:00 pm EST

12:30 pm EST

Donna Dorozinsky
President & CEO
Just in TIME GCP

1:00 pm EST

Panel

Dawn Niccum
Sr. Director, QA and Compliance
Inseption Group
Adora Nwazota
Quality Professional
Abbott
Amy Lounsbury
Research Director
MNGI Digestive Health

1:30 pm EST

Gordon D. Bedford
Regulatory Documentation Specialist
Evelo Biosciences

2:00 pm EST

2:30 pm EST

Karen Roy
Chief Strategy Officer
Phlexglobal

3:00 pm EST

Panel

Barbara Novak
Associate Director, Systems & Process Management, Clinical Operations
Kyowa Kirin Pharmaceuticals

3:30 pm EST

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