Proactive GCP Compliance

FDA is changing its focus on inspections and accountability. More quality system inspections are taking place during the conduct of studies, and increased enforcement actions are being considered against senior management for noncompliance. Globally, the regulatory environment is also changing with additional agencies conducting inspections. Inspection frequency, level of review and number of findings also continue to increase. Proactively building and maintaining an effective quality management system for GCPs has become more and more important to keep pace with these changes.

Is your company ready?

ExL Pharma’s premier gathering on Proactive GCP Compliance: Building in Quality to Meet New Requirements and Ensure Patient Safety is an opportunity for senior level clinical quality and compliance professionals to share their experiences with the changing enforcement paradigm both in the US and globally. A tougher, more visible FDA, determined to restore public trust, means increased scrutiny around sponsor oversight of trials, more rigorous standards around multi-national trials, and greater accountability from Sponsor senior management.

Address and Overcome the Challenges Facing:

• The FDA’s request for data-driven metrics
• Utilizing the right metrics to trend quality performance across a program
• The movement from being QA-driven to being quality management-driven
• The differences in ex-US inspection programs and their impact
• The streamlining around the issuance of Warning Letters and deadlines for close-out
• Ethics and regulations around conducting trials in emerging regions
• Interpreting and applying different countries’ regulations
• and more

The Shape of the Program Agenda
On Day One, we are pleased to offer two half-day pre-conference workshops:

1. Organizing Your Clinical Trial Data for Better Utilization and Decision-Making, led by The Troll Advisory Group
2. Meeting the Changing Paradigm for GCP Inspection Readiness, led by Johnson & Johnson and Wyeth

Day Two, the first day of the Main Conference, offers a series of presentations and panel discussions that focus on:

• GCP enforcement trends and our industry’s response, featuring officials from the FDA and EMEA
• The move to quality management systems and strategies that reflect the large, small, and virtual company models
• The trending of audit data
• The recent Guidances on investigator responsibility and adverse event reporting to IRBs

Finally, at the close of Day One, we offer you the opportunity to participate in moderated roundtable discussions on a variety of topics. Our goal is to make this conference rich with shared knowledge, case experience and expert recommendations.

On Day Three, we are pleased to announce a series of presentations on maintaining GCP compliance globally with presentations that represent inspectional trends from:

• The UK’s MHRA
• Health Canada
• The New Independent States of the Former Soviet Union
• China and other smaller, southeast Asia countries
• PMDA

We also discuss the ethics, quality and compliance issues surrounding emerging regions.

Don’t Get Caught in Reactionary Mode
Even a minor finding by regulatory authorities requires greater resource allocation and a shift in priorities that can impede daily operations. The quality bar has been raised, and our industry must follow. We look forward to helping you meet your GCP requirements through a proactive approach beginning on March 29th in Washington DC.