Proactive GCP Compliance Conference

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


Philadelphia, PA, United States

Now in its tenth 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.

Top Five Reasons to Attend

  1. This is the original GCP event and the only event with a longstanding history of delivering quality education and attracting a senior-level audience comprised of clinical quality, compliance, and operations professionals with the power to influence industry change.
  2. This influential event has become the annual gathering of senior-level clinical executives and acts as a candid forum to share experiences, conduct meaningful conversations and make valuable connections.
  3. Benefit from educational sessions on topics identified through intensive industry research to be the most critical issues surrounding and barriers to achieving GCP compliance, including identifying risk indicators, measuring compliance, risk-based monitoring, inspection readiness, quality by design, vendor oversight, clinical CAPAs, quality systems implementation and many more.
  4. Case study presentations from renowned industry leaders spearheading the development and implementation of proactive risk-based approaches to managing quality in clinical research, representing companies of all sizes.
  5. Customizable agenda allows you to choose your preferred topics and learning environment with interactive workshops, session tracks, educational presentations, interactive panels, intimate roundtables and ample networking opportunities.

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

Speakers

  • Nancy Bitters, Inspection Management Lead, Biopharma, Global Research and Development Quality, EMD SERONO
  • Reetu Dandora, Executive Director, Strategic Quality Oversight Lead, MRL QUALITY ASSURANCE
  • Greg Dombal, Chief Operating Officer, HALLORAN CONSULTING GROUP
  • Jason Donnelly, Director, Clinical Quality and Compliance, SCHOLAR ROCK, LLC
  • Deb Driscoll, Vice President, Quality Assurance, MERCK RESEARCH LABS
  • Celeste M. Gonzalez, B.S., CVT, RQAP-GCP, CCRP, Principal Specialist, Clinical Quality Assurance, BOSTON SCIENTIFIC
  • Sheila Gwizdak, Principal Consultant , HALLORAN CONSULTING GROUP
  • Dr. Jeff Kingsley, CEO, IACT HEALTH
  • Cheryl McCarthy, RQAP-GCP, CQA, CBA, Associate Director, R&D Quality and Compliance, BIOGEN
  • Dawn M. Niccum, M.S., RN, PMP, CCRA, RQAP-GCP, Senior Director, Quality Assurance and Compliance, INSEPTION GROUP
  • Dave Nickerson, Head of Clinical Quality Management, EMD SERONO
  • April Rafkind, M.Sc., Director, Pharma Clinical Quality Assurance, NOVARTIS
  • Sharon Reinhard, M.S., Clinical Compliance Solutions, Consultant on Assignment, MERCK
  • Karin Rezzonico, Associate Director, Clinical Quality Compliance, INSEPTION GROUP
  • Dan Walsh, Director, Clinical Oversight, MYLAN
  • Jolie Weintraub, Executive Director, Quality Assurance, Therapeutic Area Head-Oncology, MERCK
  • Michele Weitz, Senior Director, GCP Compliance Operations, CLOVIS ONCOLOGY, INC.
  • Steven Whittaker, Senior Consultant, THE AVOCA GROUP
  • Michael Wieczerak, Associate Director, Clinical Quality Management, EMD SERONO
  • Jane Wood, Quality Center of Excellence Lead, YOUR ENCORE
  • Liz Wool, President, WOOL CONSULTING GROUP, INC.
Workshops - Monday, March 18, 2019

Conference Day One
- Tuesday, March 19, 2019

Conference Day Two - Wednesday, March 20, 2019

Venue

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

Discover a huge variety of Philadelphia attractions and activities within minutes of The Inn at Penn, a Hilton hotel. We're right on the campus of the University of Pennsylvania. From museums and tours to art and cultural and family attractions, there's a whole vibrant city to discover.
Event details
Organizer : ExL Events
Venue : The Inn at Penn, A Hilton Hotel, Philadelphia, PA, United States
Event type : Conference
Reference : ASDE-19147