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Proactive GCP Compliance Conference

Effective Risk-Based Approaches for Optimizing Clinical Quality and Achieving Inspection Readiness

Philadelphia, PA, United States

Now in its eleventh year, our Proactive GCP Compliance conference continues to act as the 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. 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.


  • New tracked program offers a selection of sessions so you can optimize your learning experience and focus on topics important to you and your company
  • Your choice of half-day workshops to experience a hands-on approach for the following topics:
    -Proactive Risk Management at Emerging Companies
    -Trial Master File
    -Define Clinical Risks and Tolerance Thresholds
    -Vendor Oversight
  • Advance your risk management strategies with forward-thinking topics like Next Level Clinical Risk Management, Clinical Data Integrity, Training the Next Generation of Quality Professionals
  • More case studies providing real, practical experiences and solutions, on topics such as Quality Analytics, GCP Quality Risk at a Small Biotech, Training Quality Professionals, Shift to Quality Culture, and more.

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


  • Beatrice Anduze-Faris, BRISTOL-MYERS SQUIBB, Vice President, Global Clinical Compliance and Continuous Improvement
  • Sharon Crugnale, SAREPTA THERAPEUTICS, Executive Director, Head of Clinical Operations
  • Sheila Gwizdak, MS, HALLORAN CONSULTING GROUP, Vice President, Quality
  • Duncan Hall, TRIUMPH RESEARCH INTELLIGENCE (TRI), Chief Executive Officer and Founder
  • Laura Herbein, MERCK, Associate Director, MRL Quality Assurance, Strategy and Business...
  • MyLe Hoang, MERCK, Director, Quality Assurance, Infectious Disease/Vaccines
  • Todd Johnson, HALLORAN CONSULTING GROUP, Principal Consultant
  • Daniel Khordi, MERCK, Executive Director, Technology and Vendor QA
  • Maryann Livolsi, MSN, RN, BILL & MELINDA GATES MEDICAL RESEARCH INSTITUTE, Senior Director, GCP Quality Assurance
  • Crissy MacDonald, Ph.D., THE AVOCA GROUP, Executive Director, Client Delivery
  • Marion Mays, PHLEXGLOBAL, Vice President, Expert Services and Consulting Solutions
  • Craig Mooney, BRISTOL-MYERS SQUIBB, Director, IRT
  • Kathleen O'Donnell, BRISTOL-MYERS SQUIBB, Head, Global R&D Clinical QMS Process Improvement
  • Louis Pasquale, IQVIA, Director, Customer Success
  • Sharon S. Reinhard, M.S., MERCK, Executive Director, MRL Quality Assurance, Strategy and Business...
  • Angela Repa, BLUEBIRD BIO, Director, Proactive Clinical Excellence
  • Jonathan Rowe, aka The Clinical Risk Dude (Big GCP Lebowski), Former Executive Director, Head of Clinical Development Quality...
  • Dawn M. Niccum, M.S., RN PMP, CCRA RQAP-GCP, INSEPTION GROUP, Senior Director, Quality Assurance and Compliance
  • Joanne Spallone, NOVARTIS, Global Development Quality Audit Head
  • JT Tan, COMPLION, Sponsor/CRO Innovation Lead
  • Tom Verish, CSL BEHRING, Senior Director, Global Data Strategy and Innovation
  • Shelly Weeks-Townsend, M.S., CQA, ZYNERBA PHARMACEUTICALS, Director, Quality Assurance
  • Michael Wieczerzak, MS, MBA, CCRP, EMD SERONO, Associate Director, Clinical Quality Management
  • Theresa Wingrove, Ph.D., IMMUNOGEN, Senior Vice President, Regulatory Affairs and Quality
  • Alicia Wolny, BLUEBIRD BIO, Senior Manager, Inspection and Risk Management

Please fill in your name and email to receive the Conference Agenda of this event.


The Inn at Penn, A Hilton Hotel
3600 Sansom Street, 19104
Philadelphia, PA, USA

To make reservations over the phone, please call 215-823-6240 and request the negotiated rate for this 10th GCP Meeting.

You must book your room by February 25, 2020 in order to receive the group rate. Please book your room early, as rooms available at this rate are limited. To make reservations online click here.
Event details
Organizer : ExL
Event type : Conference
Reference : ASDE-21779