Quality Oversight of Clinical Vendors

Faculty

Katie Alberta
Senior Director Worldwide QA, Good Clinical & Pharmacovigilance Practices
TEVA PHARMACEUTICALS
Strategy & Operations / Life Science
Deloitte Consulting LLP
Angela Berns
Associate Director and Head of Vendor Program, Clinical Quality Assurance
UCB BIOSCIENCES INC.
Carol Bognar
Senior Director, GCP Services
THE WEINBERG GROUP INC.
Senior Director, Clinical Operations
MILLENIUM: THE TAKEDA ONCOLOGY COMPANY
Branch Chief, Good Clinical Practice Branch 1, Division of Scientific Investigations
OFFICE OF COMPLIANCE, FDA/CDER
Donna Edgerton
Senior Director, Clinical Quality Standards QA
MILLENNIUM: THE TAKEDA ONCOLOGY COMPANY
Marta Fields
Director, Clinical Quality Assurance
SEATTLE GENETICS
Gayatri Girwarr (GG), MD
President/Owner and CEO
GG PHARMA CONSULTING, INC.
VP, Corporate QA and Compliance
CELTIC THERAPEUTICS DEVELOPMENT
Annette Horner
Senior Director, Clinical Compliance
COMPLIANCE IMPLEMENTATION SERVICES (CIS)
Maryann Livolsi, MSN, RN
Director, R&D Compliance & Process
SHIRE
Expert Clinical Trial Head, Respiratory, Clinical Development & Medical Affairs
NOVARTIS PHARMACEUTICALS CORPORATION
Joanne S. Malia
Associate Director, Medical Research Process Management
PURDUE PHARMA, LP
David Marks, RQAP-GCP
Global Vice President, Quality Management
RESEARCH PHARMACEUTICAL SERVICES, INC. (RPS)
Office of Special Investigations and Government Liaison
PPD
Director, Medical Operations, Senior Director, Clinical Operations
IRX THERAPEUTICS
Munish Mehra
Managing Director
GLOBAL DRUG DEVELOPMENT EXPERTS
Kenneth G. Olovich, RPh, MBA
Chief Operations Officer, Chorus Resonance
a division of Lilly Research Laboratories
Richard Reeve
Senior Director, QA
ENDO PHARMACEUTICALS
Sharon S. Reinhard, MS
Associate Director, Clinical Quality Control
ENDO PHARMACEUTICALS
S. Michael Sharp, PhD, FRAPS
VP, Regulatory Quality and Clinical Affairs
AngioDynamics
Joanne Spallone
Global Head, Franchise QA, Primary Care & Translational Medicine
NOVARTIS PHARMACEUTICALS CORPORATION
Stan Szpindor, MS, Pharm
Director, Global R&D Quality Assurance
SHIRE PHARMACEUTICALS
Rod Thorell
Director of Quality Management and Compliance
PHT CORPORATION
Head, Vendor QA
PFIZER, INC.
Lead Advisor, Compliance Advice and Assurance
ASTRAZENECA
Liz Wool, CCRA, CMT
President & CEO
QD-QUALITY AND TRAINING SOLUTIONS, INC.; Member, Board of Trustees, ASSOCIATION OF CLINICAL RESEARCH PROFESSIONALS (ACRP)
Vice President, Clinical Operations
POZEN, INC.