With the pharmaceutical regulatory environment constantly evolving, it is extremely important to always be prepared for an inspection during a clinical trial. As sponsors of clinical trials, pharmaceutical companies are required to ensure GCP guidelines are upheld by implementing inspection readiness. Inspections are a crucial part of clinical trials, and it is extremely important that all companies are ready and properly follow GCP guidelines. Inspections are an ongoing process involving all stakeholders, and the real question is how/what can you do in your organization to reduce the frequency of inspections? By properly preparing for inspections, adopting and understanding all the requirements, and having good documentation and data management, companies will have a better chance of warding off inspections and have successful outcomes their trials.
The conference has grown over the past few years, and 2018 will expand on new topics, case studies and featured panel discussions. Don't miss out on the 7th Clinical Trials Inspection Readiness Summit on August 13 -14 in Philadelphia to learn how to maximize inspection readiness and trial successes through better documentation and operational standards.
Top Five Reasons to Attend
- Explore different perspectives on inspection readiness to improve clinical operations and guarantee success
- Analyze how to better prepare for inspections and outline the most important factors in maintaining a successful inspection readiness
- Discuss the impact and aligning of ICHE6 R2 to ensure compliance and risk management
- Implement the culture of inspection readiness and understand how to successfully improve clinical quality to ensure better documentation management
- Review the BlMO realignment and truly understand adopting and living according to new regulations
Who Should Attend
This conference is designed for professionals from academia, pharmaceutical, medical device, and biotechnology companies CROs with responsibilities in the following areas:
- Inspection Readiness Preparation/Quality Assurance/Quality Control/ Quality Compliance/Quality Management
- Clinical Operations/Research/Planning
- Clinical Outsourcing and Development
- Records/Data Management
- R&D Operations
- Trials Management/Research
- Global Compliance
- Risk-Based/Centralized Monitoring
- Safety and Risk Management Operations
- Site Performance Management
- Internal/External Auditing
- GCP, GVP
- Clinical Project Management
- Trial Master Files
- Clinical Documentation Management
- Global Regulatory Affairs
- CAPA Auditing
- Adverse Event Management
- Metrics and Benchmarks
- Process Optimization
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
- Readiness Consultants
Speakers
- Nancy Bitters, GCP Inspection Lead, EMD SERONO
- Jamie Bridges, Director, GDMS, Operational Excellence, MERCK
- Grace Crawford, VP Clinical Quality and Compliance, MEDIMMUNE
- Elias Dorfman, Clinical Quality Manager, MERCK
- Kathy Goldstein, Pharm.D., R.Ph., Senior Director, Clinical Quality Operations, R&D Quality and Compliance, ALEXION
- Gerry Grove, Director, Clinical Operations, Respiratory, Inflammatory and Autoimmunity, MEDIMMUNE
- Sheila Gwizdak, Director, Training and Quality Management, ALEXION
- Tipsuda Kongtong, Manager, Clinical Quality Assurance, EISAI
- Carrie Lauer, Senior Manager Clinical Operations, GE HEALTHCARE
- Ann McCabe, Director, Process Excellence and Risk Management Clinical Development Operations, DAIICHI SANKYO
- Laura Naranjo, Manager, TMF Operations, DAIICHI SANKYO
- Lydia Milne, Director Quality Systems Inspection Program, ASTELLAS
- Vaishali Shukla, Director, Due Diligence and Quality Integration, SHIRE
- Johanna Stamates, Executive Director, Research Compliance and Quality Assurance, UNIVERSITY OF MIAMI
- Katherine Taylor, GCP Inspection Lead, MERCK
- Steven B. Whittaker, Senior Consultant, Executive Director, THE AVOCA QUALITY CONSORTIUM
Please fill in your name and email to receive the conference agenda of this event.
Conference Day One - Monday, August 13
Conference Day Two - Teusday, August 14
The agenda is available as PDF under downloads at the right side of the page.
Venue
The venue is not yet available for this event.
Follow this event to be informed when the venue is available and stay informed on other changes.
Venue
The Inn at Penn, A Hilton Hotel3600 Sansom Street
Philadelphia, PA 19104
Enjoy beautifully appointed Ivy League accommodations in the culturally rich and diverse neighborhood of University City, within easy walking distance of some of the nation’s most prestigious medical, educational and corporate centers.
To make reservations over the phone, please call 215-823-6240 and request the negotiated rate for ''ExL's August Meetings.'' To make reservations online
Click HereYou must book your room by June 23, 2018, in order to receive the group rate. Please book your room early, as rooms available at this rate are limited.
