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Tuesday, June 26 • 10:30am - 11:30am
#236: Executives Respond to the State of the Industry Report on Risk-Based Approaches in Clinical Trials: Opportunity or Threat?

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-18-580-L04-P; CME 1.00; IACET 1.00; RN 1.00

Part didactic presentation, part lively debate and discussion among an executive panel, dive deep into the state of risk in clinical trials and explore our data on risk assessment and risk-based approaches to clinical trial oversight and execution.

Learning Objectives

Identify the most recent information regarding the state of the industry for familiarity, use, impact and satisfaction with risk assessment and risk-based approaches in clinical research; Develop new perspectives on how to shape their individual and organizational perspectives and positioning with respect to changing regulatory requirements and evolving risk landscape.


Dennis Salotti


Neil McCullough

Elizabeth Luczak, MBA

avatar for Elizabeth Luczak

Elizabeth Luczak

Vice President, R&D Quality Assurance, Vertex Pharmaceuticals
Elizabeth is Vice President of R&D Quality Assurance at Vertex Pharmaceuticals. Prior to joining Vertex, she has held positions of increasing scope and responsibility within quality/compliance across a number of biopharma organizations; her most recent experience was at Covance/LabCorp... Read More →
avatar for Neil McCullough

Neil McCullough

Executive Vice President, Clinical Quality and Compliance, ICON Clinical Research
Dr. McCullough has vast experience leading global quality and compliance teams within the industry. His expertise in quality assurance, regulatory affairs, risk-based auditing, continuous improvement, and project management are relied upon by PPD and its clients to achieve high quality... Read More →
avatar for Dennis Salotti

Dennis Salotti

Chief Operating Officer, The Avoca Group
With 20 years in the pharmaceutical industry as a sponsor, provider, and consultant, Dennis Salotti's experience spans preclinical research, clinical operations, data management, quality assurance, eClinical, business operations, and strategic management. Prior to Avoca, he was Director... Read More →

Tuesday June 26, 2018 10:30am - 11:30am EDT
Room 205C Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  08: R and D Quality-Compliance, Forum