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ACRP Quality Congress

Quality and Risk Management through Industry Collaboration

The 2019 Quality Congress is sponsored by HyperCore

The 2019 Quality Congress is sponsored by HyperCore

Music City Center, Room 202 B/C

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 ($399).

 

Preliminary Agenda

Breakfast
7:00-8:00am

Jim Kremidas, ACRP

Jim Kremidas, ACRP

Welcome and Introductions
8:00-8:05am

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

  • Jeff Kingsley, Founder and CEO, IACT Health

  • Mark Lacy, President and CEO, Benchmark Research


Kristen Bennett, The Avoca Group

Kristen Bennett, The Avoca Group

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:

Moderator Steve Whitaker, PharmaPM Consulting, LLC

Moderator Steve Whitaker, PharmaPM Consulting, LLC

  • 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


Andy Lee, Merck

Andy Lee, Merck

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

  • Ann Meeker-O’Connell, Vice President and Global Head QA, IQVIA

  • Andy Lee, SVP, Head of Global Clinical Trial Operations, Merck


Break
9:50-10:10am


Donna Hellsten, PPD

Donna Hellsten, PPD

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

  • Doug Schantz, Executive Director, Clinical Operations at AstraZeneca


Susan Romberg, Premier Research

Susan Romberg, Premier 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