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Wednesday, September 29 • 1:45pm - 2:45pm
PANEL: GCP Inspection Gossip

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Share Recent Experiences with Inspections and Other Engagement with Various Regulatory Authorities 
  • Discuss recent inspection experiences during the pandemic
    • Share communication with regulatory agencies during the pandemic
    • Were you part of a hybrid or remote inspection?  What did that look like?
  • Understand experiences with direct access to systems and the associated challenges

Speakers
avatar for Maryann Livolsi

Maryann Livolsi

Senior Director, GCP Quality Assurance, BILL & MELINDA GATES MEDICAL RESEARCH INSTITUTE
Accomplished leader in R&D Quality Assurance with effective management experience worked in small, mid-sized, large pharmaceutical/bio-pharmaceutical and a non-profit bio-pharmaceutical company, in depth knowledge in clinical trial management, GXP auditing, process gap analysis, SOP... Read More →
avatar for Jonathan Taylor

Jonathan Taylor

Vice President, Global Head Product Development Quality, ROCHE/GENENTECH
Over 20 years Quality Assurance experience (GLP, GCPv, GCP, PV) for major pharmaceutical and contract research companies.  Senior Management and Global Leadership Team experience.Experienced in conducting Investigator site, document, database, internal system, CRO, clinical laboratory... Read More →
avatar for Michele Weitz

Michele Weitz

Senior Director, Clinical Standards and Innovation, CLOVIS ONCOLOGY
A pragmatist on a mission to make clinical trial regulatory requirements meaningful and accessible to a tough crowd, Michele has worked as both an employee and consultant at pharmaceutical companies of all sizes—from 23 to 111,000 employees, in many therapeutic areas and around... Read More →
avatar for Donna Dorozinsky

Donna Dorozinsky

President and CEO, JUST IN TIME GCP
As the President & CEO of Just inTime GCP, Donna is responsible for running all facets of the business.   She is a business consultant who has over 30 years of experience in study operations that includes clinical operations, safety, data management, biostatistics, clinical supply... Read More →


Wednesday September 29, 2021 1:45pm - 2:45pm EDT