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Past event: Clinical Trials Inspection Readiness Summit

Improve Stakeholder Engagement to Explore a Transition to Maintain Preparation Standards, Organized Documentation, and Continuous Vigilance Throughout Your Clinical Trial

During the clinical trial process, sponsor organizations need to be prepared for regulatory authorities that conduct inspections to ensure that your process is meeting GCP standards. This year, we will focus on collaboration, considering CRO's and clinical sites need to work with sponsors to pass inspections whether it is announced or unannounced.

The 8th Clinical Trials Inspection Readiness Summit is intended to arm attendees with strategies when designing and implementing a culture of preparedness. Through interactive sessions that discuss success strategies as well as the hardships that others have to deal with, you will have the opportunity to ensure you are properly prepared for your next inspection.

Top Five Reasons to Attend

  1. Use different perspectives of inspection readiness to improve clinical operations and guarantee success
  2. Promote and ensure compliance with all regulatory agencies and their regulations using new systems and innovative methodologies
  3. Ensure trials are organized with improved oversight and communication to protect study participants' rights, safety, and welfare
  4. Foster intelligent design of clinical trial inspection readiness procedures by identifying trends that improve and encourage inspection readiness from past inspection metrics
  5. Assure quality and compliance is paramount and convert inspection readiness from a singular activity to an organizational culture for successful clinical trials

Who Should Attend

This conference is designed for professionals from academia and pharmaceutical, medical device and biotechnology companies with responsibilities in the following areas:
  • Quality Assurance/Quality Control/Quality
  • Compliance/Quality Management
  • Clinical Operations/Research/Planning
  • Outsourcing/Development
  • Records/Data Management
  • R&D Operations
  • Clinical Trials Management
  • Global Compliance
  • Risk-Based/Centralized Monitoring
  • Clinical Research
  • Safety and Risk Management Operations
  • Internal/External Auditing
  • Clinical Project Management
  • Trial Master Files
  • Clinical Documentation
  • Clinical Site Management
  • Global Regulatory Affairs
  • CAPA Auditing
  • Adverse Event Management
  • Metrics and Benchmarks
  • Process Optimization
  • Site Performance Management

The conference may also be of interest to the following:
  • CROs
  • Inspection Readiness Software Providers
  • Data/Records/Archive Management Vendors
  • TMF Vendors
  • Quality Management Service Providers
  • Electronic Signature Companies
  • Regulations/Documentation/Inspection
  • Readiness Consultants


  • Stacey L. Basham, Assistant Director, R&D GCP Quality Assurance, ABBVIE
  • 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
  • Darshan Kulkarni, FDA Regulatory and Compliance Attorney, THE KULKARNI LAW FIRM
  • Vinita Leslie, Director, Trial Master File Process Owner, Regulatory Operations, BIOGEN
  • Tian Luo, Clinical Inspection Readiness Leader, SANOFI
  • Stephanie Mangigian, Commander, United Public Health Service, Certified Bioresearch Monitoring Specialist, FOOD AND DRUG ADMINISTRATION
  • Marion Mays, VP Client Solutions and Quality Assurance, PHLEXGLOBAL
  • Ann McCabe, Director, Process Excellence and Risk Management Clinical Development Operations, DAIICHI SANKYO
  • Lydia Milne, Director Quality Systems Inspection Program, ASTELLAS
  • Laura Naranjo, Manager, TMF Operations, DAIICHI SANKYO
  • Eric Rubinson, Director, R&D Solutions, INTRA-CELLULAR THERAPIES
  • Katherine Taylor, Director, GCP Inspection Lead/ GCP Inspection Management, MERCK
  • Nelson A. Vega, Manager, Quality Assurance, UNIVERSITY OF MIAMI
  • Michele Weitz, Senior Director, GCP Compliance Operations, CLOVIS ONCOLOGY, INC.
  • Michael Wieczerzak, Associate Director, Clinical Quality Management, EMD SERONO

Please fill in your name and email to receive the Conference Agenda of this event.


Sonesta Philadelphia Downtown Rittenhouse Square
1800 Market St, 19103
Philadelphia, PA, USA


Sonesta Philadelphia Downtown Rittenhouse Square
1800 Market Street
Philadelphia, PA 19103

Explore the comfort and fresh, contemporary vibe at Sonesta Philadelphia Downtown Rittenhouse Square. A premier choice among hotels in Philadelphia, enjoy spacious, modern accommodations and luxurious amenities while staying in the heart of downtown and only steps away from Rittenhouse Square.

To make reservations, guests can call 1-800-SONESTA (766-3782) and request the group rate for ExL's 2nd Trial Master File Institute-Philadelphia. To make reservations online Click Here

The group rate is available until July 23, 2019. Please book your room early, as rooms available at this rate are limited.
Event details
Organizer : ExL
Event type : Conference
Reference : ASDE-20430