Agenda at a Glance

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Day One

Tuesday, September 15, 2020

10:30 am

10:45 am

Keynote:

Tamika Jackson
Chief Executive Officer
CrO Biosciences

11:15 am

Martina Duevel
Systems Excellence Project Leader
Bayer AG

11:45 am

Panel Session

Aryn Knight, BS, CCRP
Administrative Director, Center for Clinical Research
Texas Heart Institute
Chrystal Payne
Clinical Document Manager
Clovis Oncology
Dawn Lundin
Compliance Director
Perelman School of Medicine, University of Pennsylvania
Barbara Novak
System and Process Management Lead, Clinical Operations
Kyowa Kirin Pharmaceuticals
Marie-Christine Poisson-Carvajal
Head of TMF & Registry Operations, Information Management, Operations Center of Excellence (CoE), Global Product Development
Pfizer Inc
Gillian Gittens
Director, e-Clinical Strategy & Solutions
TransPerfect

12:45 pm

1:15 pm

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

1:45 pm

Jamie Marie Toth, CPM, MS
Director, Head of TMF Operations, Clinical Development Operations
Daiichi Sankyo, Inc.

2:15 pm

2:30 pm

Rick Arlow
CEO
Complion

3:00 pm

Case Study

Lauren Watson
Clinical Consultant

3:30 pm

Gillian Gittens
Director, e-Clinical Strategy & Solutions
TransPerfect

4:00 pm

Day Two

Wednesday, September 16, 2020

10:00 am

10:15 am

Paul Fenton
President and CEO
Montrium

10:45 am

Ruby Scott
TMF Project Manager
LMK Clinical Research Consulting

11:15 am

Stephanie Viscomi
Associate Director, TMF Operations
Alexion Pharmaceuticals

11:45 am

12:15 pm

Karen Roy
Chief Strategy Officer
Phlexglobal

12:45 pm

Panel

Sholeh Ehdaivand
President and CEO
LMK Clinical Research Consulting
Laura Naranjo
Associate Director, TMF Operations Clinical Systems & Records Global Clinical Operations & Planning
Daiichi Sankyo

1:30 pm

Joanne Malia
Director, Clinical Documentation Management
Regeneron

2:00 pm

2:30 pm

Case Study

Ronla Prince
TMF Services Lead, Document and Unified Clinical System, Processes and Enabling Solutions
AstraZeneca

3:00 pm

Jim Markley
Project Lead
Just in Time GC

3:30 pm

Panel

Hobson Lopes
Manager, Clinical Archive Management, Regeneron Pharmaceuticals
Regeneron Pharmaceuticals
Gordon Bedford
Regulatory Documentation Specialist
Evelo Biosciences
Marion Mays
Vice President, Expert Services and Consulting Solutions
PHLEXGLOBAL

4:15 pm

4:45 pm

Day Three

Thursday, September 17, 2020

10:00 am

10:15 am

Lisa Mulcahy
Principal Consultant
Mulcahy Consulting, LLC

11:00 am

Case Study

Lori Ridge
Senior Trial Master File Project Manager, Global Clinical Operations
Mylan

11:30 am

12:15 pm

Dawn Niccum
Sr. Director, QA and Compliance
Inseption Group

12:45 pm

Rachelle Longest
Clinical System Specialist
Smith & Nephew

1:15 pm

1:45 pm

Case Study

Larry Fish
Head of Clinical Compliance Operations
CSL Behring

2:15 pm

Supriya Shoroff, MS
Associate Director - TMF, Clinical Operations
AMAG Pharmaceuticals, Inc.

2:45 pm

Day Four

Friday, September 18, 2020

10:00 am

10:15am

Donna Dorozinsky
President & CEO
Just in TIME GCP

10:45am

Priya Chaturvedi
VP, Clinical Quality Assurance
Eisai

11:15 am

11:45 pm

Joana Loresto
Clinical Documentation Manager
Rigel Pharmaceuticals

12:15 pm

Anusha Rameshbabu
Trial Master File Process Specialist
Alexion Pharmaceuticals
Stephanie Viscomi
Associate Director, TMF Operations
Alexion Pharmaceuticals

1:00 pm

Case Study

Shannon Simpson
Trial Master File Manager
PATH’s Center for Vaccine Innovation and Access

1:30 pm

2:00 pm

Case Study

Gabriela Gottlieb
Clinical Quality Assurance Manager
Terumo Medical Corporation

2:30 pm

Panel Discussion

Gordon Bedford
Regulatory Documentation Specialist
Evelo Biosciences
Dawn Niccum
Sr. Director, QA and Compliance
Inseption Group
Ronla Prince
TMF Services Lead, Document and Unified Clinical System, Processes and Enabling Solutions
AstraZeneca
Saurabh Kothari
Director of Regulatory Affairs
Evelo Biosciences
Alexander Markiel
Director
Nektar Therapeutics
Rita Verma
Head of Global Clinical Affairs
Natus

3:30 pm

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