Agenda at a Glance

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Day One

Wednesday, February 24, 2021

All Times in Eastern Standard Time

9:45 am EST

Karen Roy
Chief Strategy Officer
Phlexglobal
Wendy Trimboli
Sr. Director, Clinical Operations Process, Systems & Inspection Readiness
ACADIA Pharmaceuticals Inc.

10:15 am EST

Donatella Ballerini
Document and Training Manager, Global Rare Disease R&D
Chiesi Pharmaceuticals

10:45 am EST

Sharon Ames
Director Client Solutions
Phlexglobal
Stephanie Mayew
Sr Manager of Clinical Operations
PRA

11:15 am EST

11:45 am EST

Joanne Malia
Director, Clinical Documentation Management
Regeneron

12:30 pm EST

Panel

Pawel Rucki
Senior Manager, TMF Operations Clinical Operations Excellence
GW Pharmaceuticals
Stephanie Viscomi
Associate Director, TMF Operations
Alexion Pharmaceuticals
Dawn Niccum
Sr. Director, QA and Compliance
Inseption Group

1:15 pm EST

1:45 pm EST

Amy Klawitter
Director, Integrated Clinical Management
Evotec

2:15 pm EST

Maria Palombini
Director, Communities & Opportunities Development; Healthcare Life Sciences Practice Leader
IEEE-Standards Association

2:45 pm EST

3:15 pm EST

Day Two

Thursday, February 25, 2021

9:45 am EST

Karen Roy
Chief Strategy Officer
Phlexglobal
Wendy Trimboli
Sr. Director, Clinical Operations Process, Systems & Inspection Readiness
ACADIA Pharmaceuticals Inc.

10:00 am EST

Lisa Mulcahy
Principal Consultant
Mulcahy Consulting, LLC

10:45 am EST

Wendy Trimboli
Sr. Director, Clinical Operations Process, Systems & Inspection Readiness
ACADIA Pharmaceuticals Inc.
Karen Roy
Chief Strategy Officer
Phlexglobal

11:15 am EST

11:45 am EST

Panel

Donna Dorozinsky
President & CEO
Just in TIME GCP
Jim Markley
Project Lead
Just in Time GC
Mallorie Sayre
Manager, eTMF
Moderna

12:30 pm EST

Panel

Laura Naranjo
Associate Director, TMF Operations Clinical Systems & Records Global Clinical Operations & Planning
Daiichi Sankyo
Barbara Novak
Associate Director, Systems & Process Management, Clinical Operations
Kyowa Kirin Pharmaceuticals
Aaron Grant
VP Solutions Consulting
Phlexglobal

1:30 pm EST

2:15 pm EST

Mark Choe
eTMF SME

3:15 pm EST

3:45 pm EST

Day Three

Friday, February 26, 2021

9:30 am EST

Karen Roy
Chief Strategy Officer
Phlexglobal
Wendy Trimboli
Sr. Director, Clinical Operations Process, Systems & Inspection Readiness
ACADIA Pharmaceuticals Inc.

9:45 am EST

Andrew Bentley
QA Manager
MiNA Therapeutics

10:15 am EST

Dawn Niccum
Sr. Director, QA and Compliance
Inseption Group

10:45 am EST

Rachelle Longest
Solutions Architect II
Transperfect Trial Interactive

11:15 am EST

11:45 am EST

Supriya Shoroff
Head of TMF Operations
AMAG Pharmaceuticals

12:15 pm EST

Sergi Hernandez Ranzani
Clinical Quality Assurance Specialist
Grifols

12:45 pm EST

Panel

Dawn Lundin
Compliance Director
Perelman School of Medicine, University of Pennsylvania
Amy Lounsbury
Research Director
MNGI Digestive Health
Ronla Prince
TMF Services Lead, Document and Unified Clinical System, Processes and Enabling Solutions
AstraZeneca
Anusha Rameshbabu
Trial Master File Process Specialist
Alexion Pharmaceuticals
Marion Mays
Vice President, Expert Services and Consulting Solutions
Phlexglobal

1:45 pm EST

2:15 pm EST

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