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Compliance and Regulatory Updates
Innovations
Partnerships
Quality Management
TMF Health
Zoom Roundtable
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Blake Adams
Florence
VP Marketing
Donatella Ballerini
CHIESI FARMACEUTICI S.p.A
Document & Training Manager, Global Rare Diseases
Wendy Beeby
Takeda Pharmaceuticals
Director, Clinical Document Management and Trial Support
Dr. Andrew Bentley
MiNA Therapeutics
Quality Assurance Manager
Colleen Butler
Syneos Health Global Headquarters
Global Head of TMF, Senior Director, TMF Operations
Priya Chaturvedi, PhD.
Eisai, Inc.
VP, Clinical Quality Assurance
Kathie Clark
Ennov
Product Director, CTMS and eTMF
Katrien Clinckx
Galapagos
Director, Head TMF Operations & Clinical Support
Ashlyn Deshaies
TG Therapeutics, Inc.
Clinical and TMF Operations Manager
Dr. Martina Duevel
Bayer AG Research & Development, Pharmaceuticals System Integration
Systems Excellence Project Leader,
Sholeh Ehdaivand
LMK Clinical Research Consulting
President and CEO
Betsy Fallen
BAFallen Consulting LLC
Principal
Liz Farrell
Biogen
Associate Director, Global Safety and Regulatory Sciences Records...
Ralph Feaga
AstraZeneca
TMF Operations Lead/Archivist
Tim Galvin
Medidata
Director of Product Management
Rebecca Halbur, A.L.M.
Biogen
Assoc. Director, Trial Master File (TMF) Systems
Nick Hargaden
Agios Pharmaceuticals
Associate Director, Clinical Systems
Barbara Hepworth-Jones
GSK
Director, Clinical Development Regulations and Advocacy, Quality &...
Etienne Hinton
Duke Clinical Research Institute
Clinical Trial Coordinator I
Alison Hussain
TransPerfect
Senior Project Manager
Kent Johnson
Arcus Biosciences
Associate Director of Records Management
Chris Jones
GlaxoSmithKline
Interim Head - Clinical Documentation, RD Clinical Operations
Russell Joyce
Heath Barrowcliff Consulting Ltd.
Director & Principal Consultant
Daniel Koppers
Phlexglobal
Head Of Research And Development
Christa Lewiski
Seqirus
Study File Manager (TMF Head)
Dylan Loch
Complion
Director, Industry Business Development
Hobson Lopes
Regeneron Pharmaceuticals, Inc.
Manager, Clinical Archive Management
Fiona MacKenzie
Alnylam Pharmaceuticals
Manager, TMF
Joanne Malia
Regeneron Pharmaceuticals, Inc.
Director, Clinical Documentation Management
Stephanie Mayew
PRA Health Sciences
Manager of Clinical Operations
Chris McSpiritt
Veeva Systems
Senior Director, Vault Clinical
Marisa Minetti
Chiesi
Head of Late Phase Clinical Trial Administration
M. Christine Morris
TransPerfect
Executive Director, Life Sciences Solutions
Barbara A. Novak, BS MT(ASCP)
Kyowa Kirin Pharmaceutical Development, Inc.
Systems and Process Management Lead Clinical Operations - NA/EU
Lisa D. Mulcahy, B.S.
Mulcahy Consulting, LLC
Owner, Principal Consultant
Mick Mullane
National Institute of Health Research (NIHR)
Innovation Lead
Laura Naranjo, M.S.J
Daiichi Sankyo
Associate Director, TMF Operations
Darshan Patel
IQVIA Technologies
Customer Success Manager, Global Delivery Services
Marie-Christine Poisson-Carvajal
Pfizer
Head of TMF and Registry
Ronla Prince
AstraZeneca
TMF Services Lead, Global Clinical Solutions, Development Operations
Ty Quinn
Florence
VP/GM Sponsors + CROs
Anusha Rameshbabu
Alexion Pharmaceuticals, Inc.
Trial Master File (TMF) Process Specialist
Eldin Rammell
Plexglobal
Head of Quality Assurance
Angel Ramos, Jr., CRM, IGP, MLIS
Daiichi Sankyo, Inc.
Manager, Clinical Records Management, Clinical Systems & Records,...
Leanne Rice
GSK
Clinical Documentation Manager
Karen Roy
Phlexglobal
Chief Strategy Officer
Pawel Rucki
GW Pharmaceuticals
Senior Manager, TMF Operations Clinical Operations Excellence
Mallorie Sayre
Moderna
eTMF Manager, Clinical Operations
Krista Serratore
Alimentiv Inc.
Team Lead, TMF Operations
Supriya Shoroff, MS
AMAG Pharmaceuticals, Inc.
Associate Director - TMF, Clinical Operations
Jay Smith
TransPerfect
Head of Product, Trial Interactive
Vittoria Sparacio
Novartis
Global Head, Clinical Document Governance & Management
Jamie Marie Toth, CPM, MS
Daiichi Sankyo, Inc
Senior Director, Clinical Systems & Records, Global Clinical...
Wendy Trimboli
ACADIA Pharmaceuticals Inc.
Senior Director Clinical Operations Process, Systems & Inspection...
Noeleen Valenzuela
Alnylam UK Limited
Associate Director, TMF and Document Management
Allison Varjavandi
Astellas
Director, Global Central Medical Files
LoriAnn M. Verna, RN, BSN
Just in Time GCP
Director, TMF Operations and Quality Assurance
Stephanie Viscomi
Alexion Pharmaceuticals, Inc.
Associate Director, TMF Operations
Courtney Wells
Avadel Pharmaceuticals
Vice President, Clinical Operations