GCP Inspection Readiness

Speakers

Liz Bodi
Liz Bodi

Principal Consultant, Organizational and Quality Solutions
HALLORAN CONSULTING GROUP

Caro Unger
Caro Unger

Director, Clinical Operations
KINNATE BIOPHARMA INC.

Chrissy J. Cochran, Ph.D.
Chrissy J. Cochran, Ph.D.
Director, Office of Bioresearch Monitoring Operations, ORA

FDA

Donna Dorozinsky
Donna Dorozinsky

President & CEO
JUST IN TIME GCP

Susan Greenbowe
Susan Greenbowe

Executive Director, Clinical QA
CHINOOK THERAPEUTICS

Susan Johansson
Susan Johansson

Senior Director, Clinical Operations
MATINAS BIOPHARMA

Dawn Lundin
Dawn Lundin

Head of Global Quality
MAPS PBC

Crissy MacDonald, Ph.D.
Crissy MacDonald, Ph.D.

Vice President, Client Delivery
WCG AVOCA

Dawn Niccum
Dawn Niccum

Executive Director, QA and Compliance
INSEPTION GROUP

Lynn O’Connell
Lynn O’Connell

Director, Clinical Quality Management, Global Clinical Operations and Planning
DAIICHI SANKYO

Loreena Sadowski
Loreena Sadowski
Senior Director RDQ-Clinical Inspection Management

BRISTOL-MYERS SQUIBB

Tim Stoddard
Tim Stoddard
Quality Consultant/Advisor; Previous Head of Quality,
FLATIRON HEALTH
Previous Clinical Quality Leader
SPARK THERAPEUTICS
Wendy Trimboli
Wendy Trimboli
Executive Director, Clinical Operations Process, Systems and Inspection Readiness
ACADIA PHARMACEUTICALS INC.
Paula Walker
Paula Walker
Quality Policy Chapter Lead, PDQ,
ROCHE
Former Head of Compliance,
MHRA
Michael Wieczerzak, MS, MBA, MPH, CCRP
Michael Wieczerzak, MS, MBA, MPH, CCRP

Associate Director, Clinical Quality Management Lead
EMD SERONO

Michele Weitz
Michele Weitz

Executive Director, Clinical Standards and Innovation
CLOVIS ONCOLOGY