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Clinical Quality Oversight Forum, A Virtual Experience
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Expert Presentation
Interactive
Networking Break
Panel Discussion
Priya Annamalai
ASTELLAS
Director, Inspection Program
Arti Bajpai
YOUR ENCORE QUALITY CENTER OF EXCELLENCE
Managing Expert
Nancy Bitters
EMD SERONO
GCP/GVP Inspection Lead
Oren Cohen, M.D.
COVANCE
Chief Medical Officer and Global Head, Clinical Pharmacology
Grace Crawford
ASTRAZENECA
Global Head, Clinical Quality and Compliance
Donna Dorozinsky
JUST IN TIME GCP
President and CEO
Lynn M. Evans
JOHNSON & JOHNSON
Head of Quality Planning and Strategy, BioResearch Quality and...
David Fryrear
ASTELLAS
Senior Vice President, Head of Clinical and Research Quality Assurance
Henry Galio
VEEVA SYSTEMS
Senior Director, Vault CTMS
Kathy Goldstein, PharmD, RPh, CCRA
REGENERON PHARMACEUTICALS, INC.
Senior Director, GCP Quality Management Lead
Celeste M. Gonzalez, B.S., CVT, RQAP-GCP, CCRP
BOSTON SCIENTIFIC
Principal Specialist, Clinical Quality Assurance
Sheila Gwizdak, M.S.
HALLORAN CONSULTING GROUP
Vice President, Quality
Jill Heinz, MHS, CCRC, CRCP
FAMILY CARE RESEARCH and INJURY CARE RESEARCH
President
Joel Kordyak
PRA HEALTH SCIENCES
Executive Director, Product Delivery
Sheri Kuss
PFIZER
Director, Clinical Quality Lead
Maryann Livolsi, MSN, RN
BILL AND MELINDA GATES MEDICAL RESEARCH INSTITUTE
GCP Compliance Leader
Dylan Loch
COMPLION
Director, Industry Business Development
Ken Lownie
AGATHA INC.
Head of Operations: Americas
Ralph Mazenko
MERCK
Executive Director, Clinical Quality
Cheryl McCarthy, CQA, CBA, RQAP-GCP
IRONWOOD PHARMACEUTICALS
Director, Research Quality
Margaret McShane
YOUR ENCORE CLINICAL CENTER OF EXCELLENCE
Managing Expert
Chris McSpiritt
VEEVA SYSTEMS
Senior Director, Vault Clinical
Barbara A. Novak, BS, MT(ASCP)
KYOWA KIRIN PHARMACEUTICAL DEVELOPMENT, INC.
Systems and Process Management Lead/Clinical Operations – NA/EU
Stacey Pipala
NOVARTIS
Head, Regulatory Compliance and Risk Management
Sharon S. Reinhard, M.S.
CSL BEHRING
Vice President, R&D QA
Devry Spreitzer
ASTELLAS
Senior Director, Data Integrity Quality Assurance
Sean Storms
CSL BEHRING
Senior Director, Trial and Quality Systems
Michael Torok, Ph.D.
ASTELLAS
Clinical Quality Assurance Head
Jolie Weintraub
MERCK
Associate Vice President, Clinical Quality Assurance
Michael Wieczerzak
EMD SERONO
Associate Director, Clinical Quality Management
