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Improve stakeholder engagement to explore a transition to maintain preparation standards, organized documentation, and continuous vigilance throughout your clinical trial
Clinical trial personnel constantly look for strategies to improve their inspection readiness operations. One of the keys to success involves proactively preparing for inspections to ensure that you are equipped for regulatory oversight at any moment. Another, larger scale practice includes creating a holistic culture within your organization through collaboration, innovation, and thoroughness. The 8th Clinical Trials Inspection Readiness Summit will provide invaluable resources and interactive discussions for attendees to help institute a culture of preparedness within their organization.
Artists / Speakers: Kristen Bennett Associate Director, Client Delivery, THE AVOCA GROUP, Nancy Bitters Inspection Management Lead, Biopharma, Global Research and Development Quality, EMD SERONO, Jamie Bridges Director, GDMS, Operational Excellence, MERCK, Sharon Brower Director, Training and Process and Continuous Improvement, BRISTOL-MYERS SQUIBB, Linda M. Coleman Director, Human Research Protection Program, YALE UNIVERSITY, Grace Crawford VP Clinical Quality and Compliance, MEDIMMUNE, Christina Deluca Associate Director, GCP Inspection Management, MERCK, Alyssa K. Gateman Associate Director, Yale Center for Clinical Investigations, Director Office of Quality Assurance and Training, YALE UNIVERSITY, Vinita Leslie Director, Trial Master File Process Owner, Regulatory Operations, BIOGEN, Ann McCabe Director, Process Excellence and Risk Management Clinical Development Operations, DAIICHI SANKYO, Lydia Milne Director Quality Systems Inspection Program, ASTELLAS, Julia Moore Associate Director, Clinical Operations, SANGAMO THERAPEUTICS, Laura Naranjo Manager, TMF Operations, DAIICHI SANKYO, Johanna Stamates Executive Director, Research Compliance and Quality Assurance, UNIVERSITY OF MIAMI, Katherine Taylor Director, GCP Inspection Management, MERCK, Ann Taylor Director, Inspection Readiness Lead, Clinical Development Quality, PFIZER, Michele Weitz Senior Director, GCP Compliance Operations, CLOVIS ONCOLOGY, INC., Michael Wieczerzak Associate Director, Clinical Quality Management, EMD SERONO
Time: 8:00 am to 5:00 pm
Early Bird Pricing — Register by June 28, 2019: USD 1895.0
Standard Pricing — Register after June 28, 2019: USD 2095.0
Onsite Pricing: USD 2195.0
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