8th Proactive GCP Compliance – 8th Proactive GCP Compliance

Now in its eighth year, Exl’s Proactive GCP Compliance conference continues to act as the annual forum for senior-level clinical quality and clinical operations executives to gather, learn and discuss strategies to achieve and maintain global GCP compliance. Join us to learn how to effectively build quality risk management approaches into your clinical operations to optimize research, maintain GCP compliance, contain costs and ensure patient safety.

Conference Chair

April Rafkind, MSc, Director, Pharma Clinical Quality AssuranceNOVARTIS

Case Study Presentations

MERCK CASE STUDY, ONE YEAR LATER: SUCCESSFUL RBM IMPLEMENTATION

Reporting on the Progress of Executing a Risk-Based Monitoring Approach and Effectively Overcoming Implementation Challenges

Suzanne LukacAssociate Director, Risk-Based Monitoring ImplementationMERCK

ALEXION CASE STUDY: QUALITY BY DESIGN

Utilizing Quality by Design Principles to Optimize Compliance and Data Integrity

Kathy Goldstein, Senior Director, Development Quality Operations, R&D Quality and Compliance, ALEXION PHARMACEUTICALS

AGENSYS CASE STUDY: TRIAL MASTER FILE

Leveraging the Trial Master File as a Tool to Proactively Identify Risk Areas

Jennifer J. Poulakos, Ph.D., Director, Development Quality Assurance, AGENSYS, INC., an affiliate of ASTELLAS PHARMA, INC.

Full-Day Seminar

THE CHANGING LANDSCAPE OF CLINICAL QUALITY AND COMPLIANCE

Conceptualizing the Future State of Clinical Quality and Compliance, and Taking Actions Today to Get There

Celeste M. Gonzalez, B.S., CVT, RQAP-GCP, CCRP, Principal Specialist, Clinical Quality Assurance, BOSTON SCIENTIFIC
Dawn M. Niccum, BSN, M.S., RN, PMP, CCRA, RQAP-GCP, Associate Director, Quality, ENDOCYTE
James Streeter, Global Vice President Life Sciences Product Strategy, ORACLE HEALTH SCIENCES
Steven Talerico, M.S.Director, GCP Inspection Management (GIM), Global Inspections Lead, Global Clinical Trial Operations (GCTO), MERCK

celeste   

 

Testimonials

Testimonials

2016 Audience Profile

Who Should Attend

This conference is designed for professionals from pharmaceutical, biotechnology and medical device companies; CROs; and other clinical trial service providers whose responsibilities involve the following:

  • Good Clinical Practice (GCP)
  • Clinical Quality Assurance (CQA)
  • Clinical Quality Control (CQC)
  • Clinical Trial Operations/Management
  • Clinical Research
  • Quality Management/Global Quality Management
  • Audits/Inspections
  • Compliance/Global Compliance
  • Data Management/Systems Operations
  • Clinical Monitoring
  • Regulatory Affairs
  • Safety and Risk Management/Operations

The event is also relevant to clinical QA, compliance and operations professionals from:

  • Quality Service Providers and Consulting Companies
  • CROs
  • Central, Imaging and ECG Labs
  • Investigative Sites
  • IRBs
  • Data Management and Software Vendors
  • Safety Reporting Vendors