2nd Annual Proactive GCP Compliance

 

 

Now it its second year, ExL Pharma’s Proactive GCP Compliance conference aims to progress the shift toward building and maintaining an effective GCP quality management system to keep pace with US and global enforcement changes. As the industry turns its attention to risk management, vendor oversight, quality metrics, clinical CAPAs and global trials, this conference offers both executive strategy and practical guidance to help navigate change.

As the one and only annual gathering for senior level clinical quality and compliance professionals, our faculty brings you timely information on:

  • The FDA’s risk-based approach to inspections
  • Oversight of clinical trial vendors
  • Process improvement and quality metrics
  • Achieving GCP compliance globally, including the emerging regions of China, India and Latin America
  • How to best work with investigator sites to ensure compliance
  • Changes in the monitoring model, including a Clinical Trial Transformation Initiative (CTTI) update
  • Collaboration between QA and Clinical Operations
  • The latest on clinical CAPA implementation
  • New perspectives on:
    • Quality Management Systems
    • Methods for inspection readiness
    • International trial ethics
    • Inspections in the UK, China, India, Canada

And more!

MORE PROGRAM CHOICE IN 2011
With 18+ sessions led by over 30 expert speakers packed into our two main conference days, our 2nd annual conference offers a choice of concurrent sessions focused on Quality Management, Risk Management and Metrics, and Global Inspectional Approaches. (Consider bringing your colleagues to ensure you collect information from both tracks!)

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 April 4th in Arlington, VA.

JUSTIFY YOUR TRIP! 
If you have to first convince your boss it’s worth your time and the company’s money to go, you’re not alone. Past conference attendees have helped us create justification documents that will let you make your case on why this is a must attend conference for you. Feel free to download and customize the letter below as you see fit, adding immediate problems you’ll be able to solve and long-term initiatives you’ll be able to implement. Chances are good you’ll be able to do those things… and more after the conclusion of our 2011 event.

 

 

 

 

Who Should Attend

C-Level, Vice President, Director & Manager level executives from the following departments at Pharma/Biotech companies, CROs and other clinical trial service providers:

  • Clinical Quality Assurance
  • Clinical Quality Control
  • Compliance/Global Compliance
  • Global Quality
  • Regulatory Affairs
  • Safety & Risk Management/Operations
  • Clinical Operations
  • Clinical Project Management
  • Clinical Monitoring


This conference is also relevant to clinical QA/compliance professionals at:

  • CROs
  • Central, Imaging and ECG Core Labs
  • IRBs
  • IVRS vendors
  • Investigative Sites
  • Data management and computer software vendors
  • Safety Reporting vendors
  • ePROs