Agenda at a Glance

Download Brochure

Day One

Tuesday, September 15, 2020

10:30 am

10:45 am

Keynote: The Ten Most Important Risk Factors to Address in order to Maintain “Real Time” Inspection-Ready TMFs

Tamika Jackson
Chief Executive Officer
CrO Biosciences

11:15 am

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 Lupa
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

12:45 pm

1:00 pm

Martina Duevel
Systems Excellence Project Leader
Bayer AG

1:30 pm

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

2:00 pm

2:15 pm

Rick Arlow
CEO
Complion

2:45 pm

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

3:15 pm

Case Study

Lauren Watson
Clinical Consultant

3:45 pm

Day Two

Wednesday, September 16, 2020

10:30 am

10:45 am

Ruby Scott
TMF Project Manager
LMK Clinical Research Consulting

11:15 am

Joanne Malia
Director, Clinical Documentation Management
Regeneron

11:45 am

12:00 pm

Karen Roy
Chief Strategy Officer
Phlexglobal

12:30 pm

Sholeh Ehdaivand
President and CEO
LMK Clinical Research Consulting

1:00 pm

Stephanie Viscomi
Associate Director, TMF Operations
Alexion Pharmaceuticals

1:30 pm

1:45 pm

Case Study

Ronla Prince
TMF Services Lead, Processes and Enabling Solutions, Development Operations
AstraZeneca

2:15 pm

2:45 pm

3:15 pm

Panel

Hobson Lopes
Manager, Clinical Archive Management, Regeneron Pharmaceuticals
Regeneron Pharmaceuticals

4:00 pm

Day Three

Thursday, September 17, 2020

10:30 am

10:45 am

Case Study

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

11:15 am

Khemraj Hirani, MPharm, PhD, RAC, CIP, CCRP, RPH, MBA
Associate Vice Chair for Research and Regulatory Compliance, Department of Medicine, Director, Regulatory Affairs Quality Assurance
University of Miami Diabetes Research Institute

11:45 am

12:15 pm

12:30 pm

Dawn Niccum
Sr. Director, QA and Compliance
Inseption Group

1:00 pm

Rachelle Longest
Clinical System Specialist
Smith & Nephew

1:30 pm

Case Study

2:00 pm

2:30 pm

Case Study

Larry Fish
Head of Clinical Compliance Operations
CSL Behring

3:00 pm

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

3:30 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

Case Study

Carol Stotebury
Associate Director, Clinical Records Management
ImmunityBio

11:45 am

12:00pm

Sharon Brower
CQA, Head of Clinical Training, Process & Continuous, Global Development Operations
Bristol Myers Squibb

12:30 pm

Joana Loresto
Clinical Documentation Manager
Rigel Pharmaceuticals

1:00 pm

Case Study

1:30 pm

1:45pm

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

2:15 pm

Case Study

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

2:45 pm

Case Study

Gabriela Gottlieb
Clinical Quality Assurance Manager
Terumo Medical Corporation

3:15 pm

Panel Discussion

Dawn Niccum
Sr. Director, QA and Compliance
Inseption Group

3:30 pm

Download Brochure
Copyright © 2020 Lincoln Health Network | Terms and Conditions | Privacy Policy