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Thursday, June 18 • 5:00pm - 6:00pm
#543 OD: ON DEMAND - Opportunities and Challenges for ICH E6 (GCP) Renovation

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Component Type: Forum
Level: Intermediate

This forum will describe findings and interpretation of a multi-regional survey and in-depth interviews, conducted to inform appropriate renovation of ICH E6 GCP.

Learning Objectives

Explain the results of a survey and in-depth interviews exploring issues and concerns related to ICH E6 (GCP); Discuss findings and insights based on results of multi-stakeholder, multi-regional, survey and in-depth interviews; Describe case studies illustrating obstacles in applying GCP to different types of trials and potential solutions.

Chair

Pamela Tenaerts, MD, MBA

Speaker

Panelist
M. Khair ElZarrad, PhD, MPH

Panelist
Janette Sylvia Panhuis, BSN, MBA, RN

Panelist
Dagmar R. Goertz



Speakers
avatar for Janette Panhuis

Janette Panhuis

Chief Operating Officer, Population Health Research Institute
Janette Panhuis is the Chief Operating Officer of Population Health Research Institute (McMaster) in Hamilton, Ontario, Canada. Ms. Panhuis joined PHRI in 2009 as the Director, Quality Assurance responsible for Quality Systems. Janette brings over 20 years of pharmaceutical research... Read More →
avatar for Dagmar Goertz

Dagmar Goertz

Director External Engagement and Business Insights, Janssen
Dagmar holds the role of Director External Engagement & Business Insights in BioResearch Quality & Compliance Organization at Janssen, Pharmaceutical Companies of Johnson & Johnson. She joined the healthcare industry in 1988. She gained several years of experience in pre-clinical/clinical... Read More →
avatar for M. Khair ElZarrad

M. Khair ElZarrad

Deputy Director, Office of Medical Policy, CDER, FDA
Dr. ElZarrad is the Deputy Director of the Office of Medical Policy (OMP) at FDA’s Center for Drug Evaluation and Research (CDER), where he leads the development, coordination, and implementation of medical policy programs and strategic initiatives. Dr. ElZarrad currently leads... Read More →
avatar for Pamela Tenaerts

Pamela Tenaerts

Executive Director, Clinical Trials Transformation Initiative (CTTI)
Dr. Tenaerts is the Executive Director at the Clinical Trials Transformation Initiative (CTTI) where she works closely with the Executive Committee to develop and implement strategies to accomplish CTTI’s mission. She provides senior level oversight of the day-to-day operations... Read More →


Thursday June 18, 2020 5:00pm - 6:00pm EDT
TBD Virtual Event Horsham, PA 19044
  08: R-D Quality-Compliance, Forum