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ACRP Quality Congress

April 12, 2019  |  The Omni Nashville Hotel  |  Nashville, TN

 

Quality and Risk Management through Industry Collaboration

Back for its second year, the ACRP Quality Congress provides an unparalleled view of the changing clinical trial landscape and offers exclusive networking opportunities with management teams from sponsors, CROs, and sites.

This half-day program will equip you with transformational approaches to improving clinical research quality. Walk away with practical knowledge and experiences that can be incorporated and communicated across your organization through a variety of interactive, engaging sessions.

NOTE — This event is NOT included with Full Conference registration and requires a separate fee.

………..  


Facilitator Steve Whitaker, President and Independent Consultant at PharmaPM Consulting, LLC

As a benefit of the Avoca-ACRP partnership, AQC Members are invited to attend ACRP’s Quality Congress the morning of Friday, April 12, free of charge. Passes include admission to the opening ceremony in the exhibit hall, the afternoon Technology Track, and the Avoca-ACRP Quality Awards & Recognition Ceremony that evening.

Contact Caryn.Laermer@theavocagroup.com to secure your free pass. Total value: $499.

 

 

Preliminary Agenda

Friday, April 12, 2019

 

Welcome and Introductions
8:00-8:05am

  • Jim Kremidas, Executive Director, Association of Clinical Research Professionals

 

Regulatory Requirements for Quality Management Systems – Challenges and Opportunities for Integrating Across Investigative Sites, Sponsors, and Providers
8:05-8:30am

  • Kristen Bennett, Senior Consultant and Project Manager, The Avoca Group

Join us as we examine the requirements established by regulations (e.g. ICH E6 (R2)) and the challenges or opportunities to align quality management systems and risk management approaches across the stakeholder groups involved in executing global clinical trials.


 

Moderated Breakouts
8:30-9:00am

Explore in an intimate, interactive setting some of the most pressing topics facing clinical research operations, including:

  • Effective Quality Management Systems Across Sponsors, Providers, and Investigative Sites That Truly Benefit Patient Safety and Data Integrity
  • Integrated Risk Management Approaches – Aligning Sponsors, Providers, and Investigative Sites to Benefit Patient Safety and Data Integrity
  • Developing Talent and Competencies to Achieve Effective Quality Management Systems and Risk Management Approaches

 

Effective Quality Management Systems Across Sponsors, Providers, and Investigative Sites That Truly Benefit Patient Safety and Data Integrity
9:00-9:50am

  • Karri Venn, President, Research, LMC|Manna Research
  • Steve Whitaker, President, PharmaPM Consulting, LLC
  • Costa Panagos, President, IQVIA
  • Andy Lee, SVP, Head of Global Clinical Trial Operations, Merck

 

Break
9:50-10:10am


 

Integrated Risk Management Approaches – Aligning Sponsors, Providers, and Investigative Sites to Benefit Patient Safety and Data Integrity
10:10-11:00am

  • Steve Whitaker, President, PharmaPM Consulting, LLC
  • Donna Hellsten, Vice President, Quality Assurance, Quality and Enterprise Learning Group, PPD
  • Nicholas Focil, Managing Director, FOMAT Medical Research

 

Developing Talent and Competencies to Achieve Effective Quality Management Systems and Risk Management Approaches
11:00-11:50am

  • Steve Whitaker, President, PharmaPM Consulting, LLC
  • Susan Romberg, SVP Clinical Operations, Premier Research
  • Sue Murray, Vice President, Quality, Agios
  • Jeff Kingsley, DO, MBA, CPI, FACRP, CEO, IACT Health

 

Closing Comments
11:50am-12:00pm