3rd Annual Proactive GCP Compliance

Now in it’s third year, ExL Pharma’s Proactive GCP Compliance conference continues to act as the only annual forum for both senior-level clinical quality and clinical operations executives to gather, learn and discuss strategies to achieve and maintain global GCP compliance. Reflecting the industry’s paradigm shift, the 2012 event focuses on risk-based approaches to clinical quality, driven by recently released US and European regulatory guidances.

The model for clinical research is changing, join us in April to learn how to build quality risk management approaches into your clinical operations to ensure quality research, GCP compliance and patient safety.

Featured Presentations Include:

INDUSTRY KEYNOTE ADDRESS
Modeling Quality within the Organization to Meet GCP Requirements

Jeffrey Kasher, PhD, Vice President & COO,Global Clinical Development,
ELI LILLY AND COMPANY

FDA AND EMA GUIDANCES
Comparing and Contrasting the Important Elements of the FDA’s Risk-Based Monitoring Guidance and the EMA’s Risk-Based Quality Management in Clinical Trials Reflection Paper

Joanne Spallone, Global Head, Franchise QA, Primary Care & Translational Medicine, NOVARTIS

CASE STUDY – INTEGRATED QUALITY MANAGEMENT PLAN
Pfizer Outlines their Pilot Program with the FDA to Implement an Integrated Quality Management Plan (IQMP)

David Nickerson, Senior Director, Clinical Quality Management,
PFIZER, INC.

EUROPEAN GCP INSPECTIONS
Effectively Planning and Preparing for European GCP Inspections

Paul Strickland, Director, Inspections & Intelligence, Global R&D Compliance, AMGEN UK, Chair, Audit Working Party,
EUROPEAN FORUM FOR GOOD CLINICAL PRACTICE (EFGCP)

CLINICAL CAPAS
Practical Approaches for Effectively Developing and Executing Clinical Corrective and Preventive Actions in the GCP Environment

Elizabeth Luczak, Vice President, Medical Regulatory Compliance, PFIZER, INC.

CASE STUDY - RISK-BASED MANAGEMENT PLAN
Writing and Executing a Risk-Based Management Plan for Clinical Programs

Sharon Reinhard, Associate Director, Compliance Operations and Oversight,
ENDO PHARMACEUTICALS

 

Who Should Attend

C-Level, Vice President, Director & Manager level executives from the following departments at Pharma/Biotech/Medical Device 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 from:

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