Clinical Trials Inspection Readiness Summit


Philadelphia, PA, United States

As clinical trials are conducted, inspections ensure the quality and integrity of care, data and drug performance. As sponsors for clinical trials, pharmaceutical companies are required to ensure GCP guidelines are upheld by implementing inspection readiness. These inspections are conducted by regulatory authorities, which all have unique regulations and caveats. These nuances make inspection readiness a difficult and resource-consuming battle. Clinical trials must be prepared for visits from countless stakeholders over their course.

In our research within the pharmaceutical industry, organizational culture should prioritize inspection readiness as a major part of clinical trial success. Unfavorable inspection findings will cause issues that could delay trials or even shut down drug development. Concentrating on more areas of inspection readiness - such as metrics, data integrity, and technology - can guarantee these findings are never a surprise.

At the 8th Clinical Trials Inspection Readiness Summit, you will understand the importance of an organizational culture of inspection readiness and how to implement that cultural change. With two days of advanced sessions, roundtables, and case studies about effective documentation standards, the culture of preparedness and improved stakeholder engagement, you will shift your organization to a quality-first, quality-always culture.

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

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
  • 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 Lead/ 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

Venue

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.